Research Article

Efficacy of Acupuncture on Pain Severity and Frequency of Calf Cramps in Dialysis Patients: a Randomized Clinical Trial
1Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Shiraz, Iran
2Shiraz University of Medical Sciences, Shiraz, Iran
3Students Research Committee, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
4Department of Internal Medicine, Shiraz Medical School, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
5Physical Medicine and Rehabilitation, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran
6Shiraz Endocrine and Metabolism Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
J Acupunct Meridian Stud 2024; 17(2): 47-54
Published April 30, 2024 https://doi.org/10.51507/j.jams.2024.17.2.47
Copyright © Medical Association of Pharmacopuncture Institute.
Abstract
Objectives: We aimed to investigate the efficacy of acupuncture as a safe alternative to the management of pain severity and frequency of calf cramps in dialysis patients compared to a control group.
Methods: Fifty dialysis patients experiencing calf cramps who met the eligibility criteria were randomly allocated to two groups. Group A received routine management, including analgesic consumption, stretching exercises, and nine acupuncture sessions, including acupoints BL57, GV26, CV4, CV6, LV3, KI 1, LU7, LU9, and GB34. Group B underwent sham acupuncture therapy at locations other than the primary acupoints in addition to following the specified routine management. The pain severity was measured using the visual analog scale (VAS), and the daily frequency of calf cramps was evaluated at baseline and one month after treatment completion.
Results: VAS scores and the frequency of calf cramps were improved one month after treatment completion in both groups. However, the improvement was significant in group A (p < 0.001), while it was not statistically significant in group B (p > 0.05). There was also a significant difference between both groups regarding reducing pain and the frequency of calf cramps, which showed the efficacy of acupuncture compared to the control group (p < 0.0001).
Conclusion: Acupuncture can decrease pain and frequency of calf cramps in dialysis patients.
Keywords
INTRODUCTION
Chronic Kidney Disease (CKD) is a global health concern, affecting millions of people worldwide. Individuals suffering from CKD often require hemodialysis, an essential therapeutic modality [1]. Regrettably, this life-sustaining procedure is often accompanied by a myriad of complications, including the occurrence of muscle cramps and pain [2]. Muscle cramps are involuntary, painful contractions of skeletal muscles that can significantly impact the quality of life for CKD patients undergoing dialysis [3]. Pain is also a common symptom in CKD patients, with a prevalence of 40-60% in those undergoing hemodialysis [4]. The exact etiology of muscle cramps and pain in CKD patients is not fully understood, but it is believed to be multifactorial, involving factors such as electrolyte imbalances, volume depletion, and nerve dysfunction [5].
Current treatments for muscle cramps and pain in CKD patients include various pharmacological interventions. These may involve quinine, non-opioid analgesics like acetaminophen, topical painkillers, gabapentin, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, vitamin E, partial agonists of opioid receptors (such as buprenorphine), and nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, non-pharmacological approaches, including stretching exercises and massage, can be effective. However, these treatments may not be effective for all patients, and some may have undesirable side effects [6,7]. Therefore, there is a need for alternative therapies to manage muscle cramps and pain in CKD patients undergoing dialysis.
Acupuncture, a traditional Chinese medicine technique, has been used for thousands of years to treat various ailments, including pain and muscle cramps [8]. It involves the insertion of thin needles into specific points on the body, known as acupuncture points, to stimulate the flow of energy (Qi) and restore balance within the body [9]. Recent studies have suggested that acupuncture may be effective in reducing pain and improving the quality of life for patients with various conditions, including CKD [10,11]. However, the evidence for the effectiveness of acupuncture in treating muscle cramps and pain in CKD patients undergoing dialysis is limited and requires further investigation.
Previous research has demonstrated the potential benefits of acupuncture in CKD patients. For example, a meta-analysis found that acupuncture improved sleep quality and reduced the severity of restless leg syndrome in CKD patients undergoing hemodialysis [12]. Another study by Che-Yi et al. [13] revealed acupuncture reduced the refractory pruritus in uremic patients. However, these studies did not evaluate the exact effect of acupuncture on muscle cramps in such patients.
This clinical trial aimed to contribute to the growing body of evidence supporting the use of acupuncture as an alternative therapy for managing muscle cramps, especially calf cramps, in CKD patients undergoing dialysis. Our investigation into the effectiveness of acupuncture in these patients aimed to offer valuable insights that could guide clinical practice and enhance the quality of life for individuals with CKD.
MATERIALS AND METHODS
1. Study design
The ethical committee of Shiraz University of Medical Sciences and Iranian Registry Clinical Trial (IRCT) approval numbers were “IR.SUMS.MED.REC.1397.480” and “IRCT20181121041716N1,” respectively. The number of participants (50 dialysis patients) was calculated using Med-Calc software with α = 0.05, β = 0.2, and r = 0.35. They were recruited from hemodialysis units at two hospitals affiliated with Shiraz University of Medical Sciences from January 15, 2020, until July 31, 2020.
2. Inclusion criteria
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Patients with ages between 30-70 years and a diagnosis of CKD undergoing hemodialysis treatment.
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History of recurrent muscle cramps.
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Undergoing bicarbonate dialysis three times weekly, with each session lasting four hours.
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At least six months have passed since the initiation of dialysis.
3. Exclusion criteria
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History of diabetes, smoking or alcohol consumption, current infectious diseases, skin lesions, acute rheumatoid arthritis, open foot ulcers, fractures, burns, deep vein thrombosis in the limbs/arms, or limb amputation as they interfered with the location of acupoints as well as the evaluation of pain intensity and the frequency of muscle cramps related to renal disease and dialysis.
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History of specific anticoagulant agents as they might increase the risk of bleeding during our intervention (acupuncture).
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History of analgesic consumption since it might interfere with the evaluation of the pain intensity.
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Patients with active lumbosacral radiculopathy, spinal stenosis, peripheral neuropathy, restless leg syndrome, anemia (ferritin levels less than 50), congestive heart failure, motor neuron diseases, chronic neuromuscular disabilities, dystonia or tetany, which could induce or mimic symptoms similar to muscle cramps.
Only participants who met all the eligibility criteria were included in the study.
4. Randomization and blinding
This was a double-blind clinical trial study in which patients were allocated to two groups using blocked randomization assignment and parallel design to investigate the effect of acupuncture on the pain severity and the frequency of calf cramps in CKD patients undergoing dialysis. The randomization sequence was produced using Microsoft Excel at a 1:1 allocation and a random block size of six. Researchers who followed patients by asking about their pain intensity using the Visual Analog Scale (VAS) and the frequency of calf cramps were blinded to the group allocations. In addition, all patients were blinded to the group allocations (acupuncture or sham acupuncture therapy) and the detailed procedure (such as the number and the location of acupoints). We confirmed that patients in both groups would receive reasonable management with similar protocols regarding analgesic consumption and stretching exercises.
5. Interventions
After obtaining written informed consent from the participants and administering routine treatments for muscle cramps and dialysis, the participants were randomly assigned to one of the two groups. It was possible to withdraw from the study willingly at any time. The intervention group (group A) received nine acupuncture sessions (three times a week) lasting for 15 minutes before hemodialysis. They also received routine management, including acetaminophen consumption with a dosage of 500 mg three times a day combined with daily stretching exercise for bilateral gastrocnemius and soleus muscles in three sets with a frequency of 5-10 repetitions. keeping the stretching position for 20-40 seconds each time. The control group (group B) underwent sham acupuncture therapy in locations other than the main acupoints with the very superficial insertion of the previously mentioned needles for nine sessions (three times a week) lasting for 15 minutes before hemodialysis as well as routine management including acetaminophen consumption and stretching exercises with the same protocols discussed for group A.
6. Acupuncture procedure
For patients in both groups, researchers thoroughly explained how the acupuncture would be performed and its possible complications. Before the hemodialysis, patients were placed in a supine and comfortable position, and acupuncture was performed using 25 × 25 Dong Bang Korean needles. During this period, the patient was monitored for serious problems, including lightheadedness, bleeding, itching, rash and erythema. Needles were finally removed from the patient’s body and discarded in safety boxes. For group A, acupuncture was done in nine distinct acupoints (BL57, GV26, CV4, CV6, LV3, KI 1, LU7, LU9 and GB34) and was performed bilaterally for seven of the points (BL57, GV26, LV3, KI 1, LU7, LU9 and GB34). The procedure was completed under clean conditions and lasted for 15 minutes. Sessions were completed three times a week (for nine sessions over three weeks) approximately 15 minutes before each hemodialysis appointment. Acupoints included:
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BL57: between the medial and lateral bellies of the gastrocnemius muscle, in the center of the calf or 8 cun under the popliteal transverse crease.
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GV26: at the base of the teeth between the upper lip and the nose.
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LV3: between the biggest toe and the second toe of each foot.
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CV4: at the center of the abdomen about four finger widths below the navel.
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CV6: at the center of the abdomen about two finger widths below the navel.
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KI 1: in the depression of the mid-sole between the second and third metatarsal bones.
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LU7: superior to the styloid process of the radial bone or 1.5 cun above the distal transverse crease of the wrist between the extensor pollicis longus and brevis tendons.
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LU9: lateral side of the radial artery and medial to the abductor pollicis longus tendon.
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GB34: lateral side of the leg, anterior and below the head of the fibula, 2 cun under the knee.
These points correspond to specific energy channels in the body, facilitating energy flow in these areas. Their efficacy in hemodialysis patients was confirmed in previous studies [14,15].
For group B, sham acupuncture therapy of unrelated locations with a very superficial depth of needle insertion was performed with the same duration and number of sessions as group A.
7. Variables and dialysis procedure
Variables such as blood pressure, pump cycles, and transmembrane pressure (TMP) impacted the severity and frequency of muscle cramps. Therefore, all patients underwent dialysis using a dialyzer containing 2 ml of NaHCO3 at 37℃. Patients were instructed to refrain from eating and drinking to control blood pressure variables before and during dialysis. Dialysis sessions were conducted with a TMP set at 500 and pump cycles at 300 ml per minute.
8. Outcome measurements
Demographic information, including age, gender, and duration of hemodialysis treatment, was obtained from the patients and recorded in the questionnaires. In this clinical trial, we used the VAS to assess the pain intensity of the muscle cramps in CKD patients undergoing dialysis. The VAS is a widely used and validated tool for measuring pain intensity. It is a straight horizontal line of fixed length, usually 100 mm, with a zero score as no pain and a score of 10 indicating the greatest pain severity. The ends are defined as the extreme limits of the pain orientated from the left (best) to the right (worst). The patient marks on the line the point that they feel represents their perception of their current state. Then, the VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks [16]. Moreover, muscle cramps were clinically diagnosed based on typical muscle spasms commonly in the calf muscles accompanied by sudden and intense pain lasting seconds to minutes, which were not associated with recent exercise. Individuals might observe the formation of firm tissue masses beneath the skin. It is also defined as involuntary repetitive firing of motor unit action potentials with high rates (up to 150 per second) resulting in a continuous muscle contraction [17]. Therefore, the average pain intensity (by the VAS) and the daily frequency of calf cramps were assessed in our study for both groups before and one month after the treatment protocol completion. Finally, the results were compared between and within groups.
9. Data analysis
The patients’ characteristics were presented in terms of frequencies and percentages for categorical variables, while continuous variables were described using the mean and standard deviation. To assess the normality of the data, the Kolmogorov-Smirnov test was employed. Since the data distribution at baseline was normal and there were no significant deviations after treatment protocol completion in both groups, independent t-tests and paired sample t-tests were used to evaluate differences in outcomes between and within the two groups. In addition, the Chi-Square technique was used to assess qualitative variables such as sex (Table 1 and Supplementary Table 1). The statistical analysis was done using SPSS software (version 24.0; IBM, Armonk, NY). A significance level of p < .05 was set for all analyses.
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Table 1 . Demographic data
Variable Total Intervention Control p-value Number of patients 49 24 25 Age (range), mean ± SD, year (39-69), 54.88 ± 7.01 (44-69), 55.33 ± 6.56 (39-67), 54.44 ± 7.52 0.66 Sex, male: female, n (%) 23 (46%):26 (53%) 11 (45%):13 (54%) 12 (48%):13 (52%) 0.87 Dialysis duration (range), mean ± SD, months (6-24), 12.2 ± 4.74 (6-24), 11.33 ± 4.51 (6-24), 13.04 ± 4.89 0.21 VAS score at baseline, mean ± SD (5-8), 6.63 ± 0.76 (6-8), 6.83 ± 0.7 (5-8), 6.44 ± 0.82 0.078 Frequency of calf cramps/day at baseline, mean ± SD (1-5), 3.46 ± 0.67 (1-5 times/day), 3.04 ± 0.95 (3-5 times/day), 3.88 ± 0.40 0.20 VAS = Visual Analog Scale.
After data collection, the collected data was subjected to rigorous analysis, and the findings are presented here. The study included a total of 50 individuals who were randomly assigned to groups A and B (comprising 25 participants in each group). Since one patient in group A could not continue the management protocol because of poor compliance for follow-up, the final data analysis was performed on a total of 49 patients (comprised of 24 participants in group A and 25 in group B). The consort diagram is shown in Fig. 1.
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Figure 1.Consort flow chart.
RESULTS
Table 1 presents the baseline data, including age, gender, and duration of dialysis for participants in both the intervention and control groups. No statistically significant differences were observed in the demographic characteristics between these two groups. The average age of all participants was 54.88 ± 7.01 years, with a male-to-female ratio of 0.86 (46% males and 53% females). The duration of hemodialysis ranged from 6 to 24 months, with a mean of 12.2 months for all patients.
The average baseline scores on the VAS for pain intensity were 6.83 ± 0.7 for group A and 6.44 ± 0.82 for group B. These scores did not significantly differ between the two groups (p = 0.078). One month after the treatment protocol completion, the scores decreased within each group, but the decrease was not statistically significant for group B (p = 0.20) despite significant improvement detected for group A (p < 0.001). Furthermore, we observed a significant difference between the two groups, with group A showing a notably greater reduction after the intervention (4.7 ± 0.74 for group A versus 6.12 ± 0.6 for group B and a p-value < 0.0001) (Fig. 2).
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Figure 2.Visual Analog Scale (VAS) scores for pain intensity before and after the intervention in dialysis patients. In the acupuncture group, the intervention comprises nine sessions of 15-minute acupuncture over three weeks in dialysis patients. Patients received acupuncture before each dialysis. In the control group, the intervention is given on the sham acupuncture points. (see methods for further details).
Regarding the baseline daily frequency of calf cramps (3.04 ± 0.95 for group A and 3.88 ± 0.40 for group B), there was no significant difference between the groups (p = 0.20). The scores were decreased within each group one month after treatment protocol completion (0.77 ± 0.72 for group A and 3.72 ± 0.74 for group B); however, the reduction was not statistically significant in group B (p = 0.161) in contrast to a significant improvement detected for group A (p < 0.001. A comparative analysis also revealed a significantly greater reduction in group A when compared to group B (p < 0.0001) (Fig. 3).
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Figure 3.Frequency of calf cramp before and after the intervention in dialysis patients. In the acupuncture group, the intervention comprises nine sessions of 15-minute acupuncture over three weeks in dialysis patients. Patients received acupuncture before each dialysis. In the control group, the intervention is given on the sham acupuncture points. (see methods for further details). ***p < 0.001 for acupuncture group before and one month after intervention and p < 0.0001 for comparison of (acupuncture and control) one month after intervention using paired sample T test and independent T test.
No complications were reported in either group during the treatment protocols.
DISCUSSION
The present clinical trial aimed to investigate the effects of acupuncture on pain intensity and the frequency of muscle cramps among dialysis patients. The results demonstrated a significant reduction in group A, who received acupuncture, compared to the control group. These findings were consistent with several previous studies that have reported the beneficial effects of acupuncture on muscle cramps and pain in dialysis patients.
For instance, a pilot study explored the effects of electroacupuncture on muscle cramps in liver cirrhosis patients, revealing significant improvement without impacting liver function [18]. Acupressure has also been investigated as a non-pharmacological intervention in hemodialysis patients, showing significant reductions in upper extremity pain and improved quality of life [19]. Similarly, another study reported decreased muscle cramps through acupressure among hemodialysis patients [16]. Acupuncture has also been examined for symptom management in hemodialysis patients, demonstrating feasibility and safety in a prospective observational pilot study [20]. Additionally, a systematic review highlighted acupuncture’s positive impact on quality of life, fatigue, and sleep in patients with CKD [17]. Furthermore, a randomized controlled trial investigated the effect of acupuncture on functional capacity and muscle strength in patients undergoing hemodialysis, with significant improvements observed [21].
The mechanism underlying the effectiveness of acupuncture in reducing muscle cramps and pain in CKD dialysis patients is not yet fully understood. However, several theories have been proposed. One possible explanation is that acupuncture stimulates the release of endogenous opioids, which are known to have analgesic effects [22]. Besides, acupuncture may modulate the activity of the autonomic nervous system, thereby reducing muscle cramps and pain [23].
Another potential explanation for the observed effects of acupuncture on muscle cramps in CKD dialysis patients is the improvement of microcirculation. A study by Zhang et al. found that acupuncture improved microcirculation in the lower extremities of hemodialysis patients, which could contribute to reducing muscle cramps [24]. Acupuncture has also been shown to have anti-inflammatory effects, which may also play a role in alleviating muscle cramps and pain in CKD dialysis patients [25].
Acupuncture has several advantages over other non-pharmacological interventions for muscle cramps in CKD dialysis patients. For instance, a study by Miller et al. [26] found that stretching exercises effectively reduced muscle cramps in dialysis patients. However, acupuncture may be more convenient and less time-consuming for patients, as it can be performed during dialysis sessions [27]. In addition, acupuncture has been shown to have fewer side effects compared to pharmacological treatments for muscle cramps, such as quinine [6].
The present study’s methodology was robust, with a well-defined intervention and control group. The randomization process ensured no significant differences in demographic characteristics between the two groups, strengthening the validity of the results.
1. Study limitations
It is important to note that the sample size was relatively small, which might limit the generalizability of the findings. Future studies with larger sample sizes would be needed to confirm the results of this study. Another limitation was a relatively short follow-up duration. Further investigations with extended follow-up periods would be necessary to evaluate acupuncture’s short-term and long-term effects in such patients. The lack of investigation of mineral and vitamin deficiencies, which could be predisposing factors for muscle cramps, was another limitation of this study. Moreover, the assessment of calf cramps primarily relied on subjective measures, specifically the participants’ self-reported pain intensity and frequency. Supplementing these subjective measures with objective techniques such as electromyography or muscle tension recordings could have yielded more precise and quantitative data regarding the impact of acupuncture on calf cramps. Finally, the inability to analyze the data from patients with poor follow-up could be another limitation. Further study with less missing data would be suggested as well.
In conclusion, the present clinical trial demonstrated that acupuncture effectively reduced calf cramps and pain in dialysis patients. These findings were consistent with previous research and supported the use of acupuncture as a safe and effective non-pharmacological intervention for muscle cramps in this patient population. Further research would be needed to confirm these findings and elucidate the underlying mechanisms of acupuncture’s effects on muscle cramps and pain in dialysis patients.
CONCLUSIONS
Acupuncture had more efficacy in decreasing pain severity and frequency of calf cramps among dialysis patients compared to sham acupuncture therapy. It could be a safe and cost-beneficial alternative to management in such patients.
ACKNOWLEDGEMENTS
This study was part of a thesis of Maryam Vejdanpak (number: 16915-01-01-97). The medical ethical committee of Shiraz University of Medical Sciences and Iranian Registry Clinical Trial (IRCT) approval numbers were “IR.SUMS.MED.REC.1397.480” and “IRCT20181121041716N1” respectively. The authors would like to thank center for development of clinical research of Namazee hospital for data analysis.
SUPPLEMENTARY MATERIAL
Supplementary data to this article can be found online at https://doi.org/10.51507/j.jams.2024.17.2.47.
FUNDING
The authors received no financial support for the research, authorship or publication of this article.
AUTHORS’ CONTRIBUTIONS
All authors had equal contribution in all aspects of this research.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
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Related articles in JAMS

Article
Research Article
J Acupunct Meridian Stud 2024; 17(2): 47-54
Published online April 30, 2024 https://doi.org/10.51507/j.jams.2024.17.2.47
Copyright © Medical Association of Pharmacopuncture Institute.
Efficacy of Acupuncture on Pain Severity and Frequency of Calf Cramps in Dialysis Patients: a Randomized Clinical Trial
Leila Sadat Mohamadi Jahromi1 , Maryam Vejdanpak2
, Rezvan Ghaderpanah3
, Seyed Hassan Sadrian3
, Alireza Dabbaghmanesh4
, Sharareh Roshanzamir5,*
, Mohammadhossein Dabbaghmanesh6
1Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Shiraz, Iran
2Shiraz University of Medical Sciences, Shiraz, Iran
3Students Research Committee, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
4Department of Internal Medicine, Shiraz Medical School, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
5Physical Medicine and Rehabilitation, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran
6Shiraz Endocrine and Metabolism Research Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
Correspondence to:Sharareh Roshanzamir
Physical Medicine and Rehabilitation, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran
E-mail sharareh.roshanzamir@gmail.com
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Patients with chronic kidney disease, as a common disorder, usually necessitate the implementation of hemodialysis. Muscle cramps are one of the most disabling complications affecting their quality of life.
Objectives: We aimed to investigate the efficacy of acupuncture as a safe alternative to the management of pain severity and frequency of calf cramps in dialysis patients compared to a control group.
Methods: Fifty dialysis patients experiencing calf cramps who met the eligibility criteria were randomly allocated to two groups. Group A received routine management, including analgesic consumption, stretching exercises, and nine acupuncture sessions, including acupoints BL57, GV26, CV4, CV6, LV3, KI 1, LU7, LU9, and GB34. Group B underwent sham acupuncture therapy at locations other than the primary acupoints in addition to following the specified routine management. The pain severity was measured using the visual analog scale (VAS), and the daily frequency of calf cramps was evaluated at baseline and one month after treatment completion.
Results: VAS scores and the frequency of calf cramps were improved one month after treatment completion in both groups. However, the improvement was significant in group A (p < 0.001), while it was not statistically significant in group B (p > 0.05). There was also a significant difference between both groups regarding reducing pain and the frequency of calf cramps, which showed the efficacy of acupuncture compared to the control group (p < 0.0001).
Conclusion: Acupuncture can decrease pain and frequency of calf cramps in dialysis patients.
Keywords: Acupuncture, Chronic kidney disease, Hemodialysis, Muscle cramp
INTRODUCTION
Chronic Kidney Disease (CKD) is a global health concern, affecting millions of people worldwide. Individuals suffering from CKD often require hemodialysis, an essential therapeutic modality [1]. Regrettably, this life-sustaining procedure is often accompanied by a myriad of complications, including the occurrence of muscle cramps and pain [2]. Muscle cramps are involuntary, painful contractions of skeletal muscles that can significantly impact the quality of life for CKD patients undergoing dialysis [3]. Pain is also a common symptom in CKD patients, with a prevalence of 40-60% in those undergoing hemodialysis [4]. The exact etiology of muscle cramps and pain in CKD patients is not fully understood, but it is believed to be multifactorial, involving factors such as electrolyte imbalances, volume depletion, and nerve dysfunction [5].
Current treatments for muscle cramps and pain in CKD patients include various pharmacological interventions. These may involve quinine, non-opioid analgesics like acetaminophen, topical painkillers, gabapentin, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, vitamin E, partial agonists of opioid receptors (such as buprenorphine), and nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, non-pharmacological approaches, including stretching exercises and massage, can be effective. However, these treatments may not be effective for all patients, and some may have undesirable side effects [6,7]. Therefore, there is a need for alternative therapies to manage muscle cramps and pain in CKD patients undergoing dialysis.
Acupuncture, a traditional Chinese medicine technique, has been used for thousands of years to treat various ailments, including pain and muscle cramps [8]. It involves the insertion of thin needles into specific points on the body, known as acupuncture points, to stimulate the flow of energy (Qi) and restore balance within the body [9]. Recent studies have suggested that acupuncture may be effective in reducing pain and improving the quality of life for patients with various conditions, including CKD [10,11]. However, the evidence for the effectiveness of acupuncture in treating muscle cramps and pain in CKD patients undergoing dialysis is limited and requires further investigation.
Previous research has demonstrated the potential benefits of acupuncture in CKD patients. For example, a meta-analysis found that acupuncture improved sleep quality and reduced the severity of restless leg syndrome in CKD patients undergoing hemodialysis [12]. Another study by Che-Yi et al. [13] revealed acupuncture reduced the refractory pruritus in uremic patients. However, these studies did not evaluate the exact effect of acupuncture on muscle cramps in such patients.
This clinical trial aimed to contribute to the growing body of evidence supporting the use of acupuncture as an alternative therapy for managing muscle cramps, especially calf cramps, in CKD patients undergoing dialysis. Our investigation into the effectiveness of acupuncture in these patients aimed to offer valuable insights that could guide clinical practice and enhance the quality of life for individuals with CKD.
MATERIALS AND METHODS
1. Study design
The ethical committee of Shiraz University of Medical Sciences and Iranian Registry Clinical Trial (IRCT) approval numbers were “IR.SUMS.MED.REC.1397.480” and “IRCT20181121041716N1,” respectively. The number of participants (50 dialysis patients) was calculated using Med-Calc software with α = 0.05, β = 0.2, and r = 0.35. They were recruited from hemodialysis units at two hospitals affiliated with Shiraz University of Medical Sciences from January 15, 2020, until July 31, 2020.
2. Inclusion criteria
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Patients with ages between 30-70 years and a diagnosis of CKD undergoing hemodialysis treatment.
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History of recurrent muscle cramps.
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Undergoing bicarbonate dialysis three times weekly, with each session lasting four hours.
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At least six months have passed since the initiation of dialysis.
3. Exclusion criteria
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History of diabetes, smoking or alcohol consumption, current infectious diseases, skin lesions, acute rheumatoid arthritis, open foot ulcers, fractures, burns, deep vein thrombosis in the limbs/arms, or limb amputation as they interfered with the location of acupoints as well as the evaluation of pain intensity and the frequency of muscle cramps related to renal disease and dialysis.
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History of specific anticoagulant agents as they might increase the risk of bleeding during our intervention (acupuncture).
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History of analgesic consumption since it might interfere with the evaluation of the pain intensity.
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Patients with active lumbosacral radiculopathy, spinal stenosis, peripheral neuropathy, restless leg syndrome, anemia (ferritin levels less than 50), congestive heart failure, motor neuron diseases, chronic neuromuscular disabilities, dystonia or tetany, which could induce or mimic symptoms similar to muscle cramps.
Only participants who met all the eligibility criteria were included in the study.
4. Randomization and blinding
This was a double-blind clinical trial study in which patients were allocated to two groups using blocked randomization assignment and parallel design to investigate the effect of acupuncture on the pain severity and the frequency of calf cramps in CKD patients undergoing dialysis. The randomization sequence was produced using Microsoft Excel at a 1:1 allocation and a random block size of six. Researchers who followed patients by asking about their pain intensity using the Visual Analog Scale (VAS) and the frequency of calf cramps were blinded to the group allocations. In addition, all patients were blinded to the group allocations (acupuncture or sham acupuncture therapy) and the detailed procedure (such as the number and the location of acupoints). We confirmed that patients in both groups would receive reasonable management with similar protocols regarding analgesic consumption and stretching exercises.
5. Interventions
After obtaining written informed consent from the participants and administering routine treatments for muscle cramps and dialysis, the participants were randomly assigned to one of the two groups. It was possible to withdraw from the study willingly at any time. The intervention group (group A) received nine acupuncture sessions (three times a week) lasting for 15 minutes before hemodialysis. They also received routine management, including acetaminophen consumption with a dosage of 500 mg three times a day combined with daily stretching exercise for bilateral gastrocnemius and soleus muscles in three sets with a frequency of 5-10 repetitions. keeping the stretching position for 20-40 seconds each time. The control group (group B) underwent sham acupuncture therapy in locations other than the main acupoints with the very superficial insertion of the previously mentioned needles for nine sessions (three times a week) lasting for 15 minutes before hemodialysis as well as routine management including acetaminophen consumption and stretching exercises with the same protocols discussed for group A.
6. Acupuncture procedure
For patients in both groups, researchers thoroughly explained how the acupuncture would be performed and its possible complications. Before the hemodialysis, patients were placed in a supine and comfortable position, and acupuncture was performed using 25 × 25 Dong Bang Korean needles. During this period, the patient was monitored for serious problems, including lightheadedness, bleeding, itching, rash and erythema. Needles were finally removed from the patient’s body and discarded in safety boxes. For group A, acupuncture was done in nine distinct acupoints (BL57, GV26, CV4, CV6, LV3, KI 1, LU7, LU9 and GB34) and was performed bilaterally for seven of the points (BL57, GV26, LV3, KI 1, LU7, LU9 and GB34). The procedure was completed under clean conditions and lasted for 15 minutes. Sessions were completed three times a week (for nine sessions over three weeks) approximately 15 minutes before each hemodialysis appointment. Acupoints included:
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BL57: between the medial and lateral bellies of the gastrocnemius muscle, in the center of the calf or 8 cun under the popliteal transverse crease.
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GV26: at the base of the teeth between the upper lip and the nose.
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LV3: between the biggest toe and the second toe of each foot.
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CV4: at the center of the abdomen about four finger widths below the navel.
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CV6: at the center of the abdomen about two finger widths below the navel.
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KI 1: in the depression of the mid-sole between the second and third metatarsal bones.
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LU7: superior to the styloid process of the radial bone or 1.5 cun above the distal transverse crease of the wrist between the extensor pollicis longus and brevis tendons.
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LU9: lateral side of the radial artery and medial to the abductor pollicis longus tendon.
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GB34: lateral side of the leg, anterior and below the head of the fibula, 2 cun under the knee.
These points correspond to specific energy channels in the body, facilitating energy flow in these areas. Their efficacy in hemodialysis patients was confirmed in previous studies [14,15].
For group B, sham acupuncture therapy of unrelated locations with a very superficial depth of needle insertion was performed with the same duration and number of sessions as group A.
7. Variables and dialysis procedure
Variables such as blood pressure, pump cycles, and transmembrane pressure (TMP) impacted the severity and frequency of muscle cramps. Therefore, all patients underwent dialysis using a dialyzer containing 2 ml of NaHCO3 at 37℃. Patients were instructed to refrain from eating and drinking to control blood pressure variables before and during dialysis. Dialysis sessions were conducted with a TMP set at 500 and pump cycles at 300 ml per minute.
8. Outcome measurements
Demographic information, including age, gender, and duration of hemodialysis treatment, was obtained from the patients and recorded in the questionnaires. In this clinical trial, we used the VAS to assess the pain intensity of the muscle cramps in CKD patients undergoing dialysis. The VAS is a widely used and validated tool for measuring pain intensity. It is a straight horizontal line of fixed length, usually 100 mm, with a zero score as no pain and a score of 10 indicating the greatest pain severity. The ends are defined as the extreme limits of the pain orientated from the left (best) to the right (worst). The patient marks on the line the point that they feel represents their perception of their current state. Then, the VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks [16]. Moreover, muscle cramps were clinically diagnosed based on typical muscle spasms commonly in the calf muscles accompanied by sudden and intense pain lasting seconds to minutes, which were not associated with recent exercise. Individuals might observe the formation of firm tissue masses beneath the skin. It is also defined as involuntary repetitive firing of motor unit action potentials with high rates (up to 150 per second) resulting in a continuous muscle contraction [17]. Therefore, the average pain intensity (by the VAS) and the daily frequency of calf cramps were assessed in our study for both groups before and one month after the treatment protocol completion. Finally, the results were compared between and within groups.
9. Data analysis
The patients’ characteristics were presented in terms of frequencies and percentages for categorical variables, while continuous variables were described using the mean and standard deviation. To assess the normality of the data, the Kolmogorov-Smirnov test was employed. Since the data distribution at baseline was normal and there were no significant deviations after treatment protocol completion in both groups, independent t-tests and paired sample t-tests were used to evaluate differences in outcomes between and within the two groups. In addition, the Chi-Square technique was used to assess qualitative variables such as sex (Table 1 and Supplementary Table 1). The statistical analysis was done using SPSS software (version 24.0; IBM, Armonk, NY). A significance level of p < .05 was set for all analyses.
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&md=tbl&idx=1' data-target="#file-modal"">Table 1 Demographic data.
Variable Total Intervention Control p-value Number of patients 49 24 25 Age (range), mean ± SD, year (39-69), 54.88 ± 7.01 (44-69), 55.33 ± 6.56 (39-67), 54.44 ± 7.52 0.66 Sex, male: female, n (%) 23 (46%):26 (53%) 11 (45%):13 (54%) 12 (48%):13 (52%) 0.87 Dialysis duration (range), mean ± SD, months (6-24), 12.2 ± 4.74 (6-24), 11.33 ± 4.51 (6-24), 13.04 ± 4.89 0.21 VAS score at baseline, mean ± SD (5-8), 6.63 ± 0.76 (6-8), 6.83 ± 0.7 (5-8), 6.44 ± 0.82 0.078 Frequency of calf cramps/day at baseline, mean ± SD (1-5), 3.46 ± 0.67 (1-5 times/day), 3.04 ± 0.95 (3-5 times/day), 3.88 ± 0.40 0.20 VAS = Visual Analog Scale..
After data collection, the collected data was subjected to rigorous analysis, and the findings are presented here. The study included a total of 50 individuals who were randomly assigned to groups A and B (comprising 25 participants in each group). Since one patient in group A could not continue the management protocol because of poor compliance for follow-up, the final data analysis was performed on a total of 49 patients (comprised of 24 participants in group A and 25 in group B). The consort diagram is shown in Fig. 1.
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Figure 1. Consort flow chart.
RESULTS
Table 1 presents the baseline data, including age, gender, and duration of dialysis for participants in both the intervention and control groups. No statistically significant differences were observed in the demographic characteristics between these two groups. The average age of all participants was 54.88 ± 7.01 years, with a male-to-female ratio of 0.86 (46% males and 53% females). The duration of hemodialysis ranged from 6 to 24 months, with a mean of 12.2 months for all patients.
The average baseline scores on the VAS for pain intensity were 6.83 ± 0.7 for group A and 6.44 ± 0.82 for group B. These scores did not significantly differ between the two groups (p = 0.078). One month after the treatment protocol completion, the scores decreased within each group, but the decrease was not statistically significant for group B (p = 0.20) despite significant improvement detected for group A (p < 0.001). Furthermore, we observed a significant difference between the two groups, with group A showing a notably greater reduction after the intervention (4.7 ± 0.74 for group A versus 6.12 ± 0.6 for group B and a p-value < 0.0001) (Fig. 2).
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Figure 2. Visual Analog Scale (VAS) scores for pain intensity before and after the intervention in dialysis patients. In the acupuncture group, the intervention comprises nine sessions of 15-minute acupuncture over three weeks in dialysis patients. Patients received acupuncture before each dialysis. In the control group, the intervention is given on the sham acupuncture points. (see methods for further details).
Regarding the baseline daily frequency of calf cramps (3.04 ± 0.95 for group A and 3.88 ± 0.40 for group B), there was no significant difference between the groups (p = 0.20). The scores were decreased within each group one month after treatment protocol completion (0.77 ± 0.72 for group A and 3.72 ± 0.74 for group B); however, the reduction was not statistically significant in group B (p = 0.161) in contrast to a significant improvement detected for group A (p < 0.001. A comparative analysis also revealed a significantly greater reduction in group A when compared to group B (p < 0.0001) (Fig. 3).
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Figure 3. Frequency of calf cramp before and after the intervention in dialysis patients. In the acupuncture group, the intervention comprises nine sessions of 15-minute acupuncture over three weeks in dialysis patients. Patients received acupuncture before each dialysis. In the control group, the intervention is given on the sham acupuncture points. (see methods for further details). ***p < 0.001 for acupuncture group before and one month after intervention and p < 0.0001 for comparison of (acupuncture and control) one month after intervention using paired sample T test and independent T test.
No complications were reported in either group during the treatment protocols.
DISCUSSION
The present clinical trial aimed to investigate the effects of acupuncture on pain intensity and the frequency of muscle cramps among dialysis patients. The results demonstrated a significant reduction in group A, who received acupuncture, compared to the control group. These findings were consistent with several previous studies that have reported the beneficial effects of acupuncture on muscle cramps and pain in dialysis patients.
For instance, a pilot study explored the effects of electroacupuncture on muscle cramps in liver cirrhosis patients, revealing significant improvement without impacting liver function [18]. Acupressure has also been investigated as a non-pharmacological intervention in hemodialysis patients, showing significant reductions in upper extremity pain and improved quality of life [19]. Similarly, another study reported decreased muscle cramps through acupressure among hemodialysis patients [16]. Acupuncture has also been examined for symptom management in hemodialysis patients, demonstrating feasibility and safety in a prospective observational pilot study [20]. Additionally, a systematic review highlighted acupuncture’s positive impact on quality of life, fatigue, and sleep in patients with CKD [17]. Furthermore, a randomized controlled trial investigated the effect of acupuncture on functional capacity and muscle strength in patients undergoing hemodialysis, with significant improvements observed [21].
The mechanism underlying the effectiveness of acupuncture in reducing muscle cramps and pain in CKD dialysis patients is not yet fully understood. However, several theories have been proposed. One possible explanation is that acupuncture stimulates the release of endogenous opioids, which are known to have analgesic effects [22]. Besides, acupuncture may modulate the activity of the autonomic nervous system, thereby reducing muscle cramps and pain [23].
Another potential explanation for the observed effects of acupuncture on muscle cramps in CKD dialysis patients is the improvement of microcirculation. A study by Zhang et al. found that acupuncture improved microcirculation in the lower extremities of hemodialysis patients, which could contribute to reducing muscle cramps [24]. Acupuncture has also been shown to have anti-inflammatory effects, which may also play a role in alleviating muscle cramps and pain in CKD dialysis patients [25].
Acupuncture has several advantages over other non-pharmacological interventions for muscle cramps in CKD dialysis patients. For instance, a study by Miller et al. [26] found that stretching exercises effectively reduced muscle cramps in dialysis patients. However, acupuncture may be more convenient and less time-consuming for patients, as it can be performed during dialysis sessions [27]. In addition, acupuncture has been shown to have fewer side effects compared to pharmacological treatments for muscle cramps, such as quinine [6].
The present study’s methodology was robust, with a well-defined intervention and control group. The randomization process ensured no significant differences in demographic characteristics between the two groups, strengthening the validity of the results.
1. Study limitations
It is important to note that the sample size was relatively small, which might limit the generalizability of the findings. Future studies with larger sample sizes would be needed to confirm the results of this study. Another limitation was a relatively short follow-up duration. Further investigations with extended follow-up periods would be necessary to evaluate acupuncture’s short-term and long-term effects in such patients. The lack of investigation of mineral and vitamin deficiencies, which could be predisposing factors for muscle cramps, was another limitation of this study. Moreover, the assessment of calf cramps primarily relied on subjective measures, specifically the participants’ self-reported pain intensity and frequency. Supplementing these subjective measures with objective techniques such as electromyography or muscle tension recordings could have yielded more precise and quantitative data regarding the impact of acupuncture on calf cramps. Finally, the inability to analyze the data from patients with poor follow-up could be another limitation. Further study with less missing data would be suggested as well.
In conclusion, the present clinical trial demonstrated that acupuncture effectively reduced calf cramps and pain in dialysis patients. These findings were consistent with previous research and supported the use of acupuncture as a safe and effective non-pharmacological intervention for muscle cramps in this patient population. Further research would be needed to confirm these findings and elucidate the underlying mechanisms of acupuncture’s effects on muscle cramps and pain in dialysis patients.
CONCLUSIONS
Acupuncture had more efficacy in decreasing pain severity and frequency of calf cramps among dialysis patients compared to sham acupuncture therapy. It could be a safe and cost-beneficial alternative to management in such patients.
ACKNOWLEDGEMENTS
This study was part of a thesis of Maryam Vejdanpak (number: 16915-01-01-97). The medical ethical committee of Shiraz University of Medical Sciences and Iranian Registry Clinical Trial (IRCT) approval numbers were “IR.SUMS.MED.REC.1397.480” and “IRCT20181121041716N1” respectively. The authors would like to thank center for development of clinical research of Namazee hospital for data analysis.
SUPPLEMENTARY MATERIAL
Supplementary data to this article can be found online at https://doi.org/10.51507/j.jams.2024.17.2.47.
FUNDING
The authors received no financial support for the research, authorship or publication of this article.
AUTHORS’ CONTRIBUTIONS
All authors had equal contribution in all aspects of this research.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
Fig 1.

Fig 2.

Fig 3.

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Table 1 . Demographic data.
Variable Total Intervention Control p-value Number of patients 49 24 25 Age (range), mean ± SD, year (39-69), 54.88 ± 7.01 (44-69), 55.33 ± 6.56 (39-67), 54.44 ± 7.52 0.66 Sex, male: female, n (%) 23 (46%):26 (53%) 11 (45%):13 (54%) 12 (48%):13 (52%) 0.87 Dialysis duration (range), mean ± SD, months (6-24), 12.2 ± 4.74 (6-24), 11.33 ± 4.51 (6-24), 13.04 ± 4.89 0.21 VAS score at baseline, mean ± SD (5-8), 6.63 ± 0.76 (6-8), 6.83 ± 0.7 (5-8), 6.44 ± 0.82 0.078 Frequency of calf cramps/day at baseline, mean ± SD (1-5), 3.46 ± 0.67 (1-5 times/day), 3.04 ± 0.95 (3-5 times/day), 3.88 ± 0.40 0.20 VAS = Visual Analog Scale..
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