Trigger Point Acupuncture and Exercise for Chronic Low Back Pain in Older Adult: a Preliminary Randomized Clinical Trial

Yoichi Minakawa; Shogo Miyazaki; Hideaki Waki; Naruto Yoshida; Kaori Iimura; Kazunori Itoh

doi:10.51507/j.jams.2022.15.2.143

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Trigger Point Acupuncture and Exercise for Chronic Low Back Pain in Older Adult: a Preliminary Randomized Clinical Trial

Yoichi Minakawa^1,2,*, Shogo Miyazaki^1,2, Hideaki Waki^1,2, Naruto Yoshida^1,2, Kaori Iimura³, Kazunori Itoh⁴

¹Department of Acupuncture and Moxibustion, Faculty of Health Care, Teikyo Heisei University, Tokyo, Japan
²Research Institute of Oriental Medicine, Teikyo Heisei University, Tokyo, Japan
³Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
⁴Department of Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Kyoto, Japan

Correspondence to:

Yoichi Minakawa
Department of Acupuncture and Moxibustion, Faculty of Health Care, Teikyo Heisei University, Toshimaku, Tokyo, Japan
E-mail y.minakawa@thu.ac.jp

Received: September 19, 2021; Revised: October 26, 2021; Accepted: December 4, 2021

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 2022; 15(2): 143-151

Published April 30, 2022 https://doi.org/10.51507/j.jams.2022.15.2.143

Abstract

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

Background: Exercise therapy is the first choice non-pharmacotherapeutic approach for musculoskeletal pain; however, it often interferes with the implementation and continuation of exercise due to fear-avoidance behaviors. Trigger point acupuncture (TrPAcp) has been reported to reduce musculoskeletal pain.
Objectives: To examine the efficacy of exercise combined with TrPAcp compared to exercise alone for older patients with chronic low back pain (CLBP), the most common subjective symptom reported by old people of both sexes in Japan.
Methods: In this single-center randomized controlled trial conducted at Teikyo Heisei University, 15 men and women aged ≥ 65 years with low back pain for at least 3 months who met the eligibility criteria were included. The Ex+TrPAcp group received exercise and trigger point acupuncture, while the Ex group received only exercise for 3 months. The main outcome, pain intensity, was measured using the numerical rating scale (NRS). Improvement was defined as a decrease in NRS of ≥ 2 or less than moderate (NRS < 4).
Results: The analysis included 7 of 8 cases in the Ex+TrPAcp group and 7 of 7 cases in the Ex group. NRS improved in 6 of 7 and 1 of 7 patients in the intervention and control groups, respectively, with a significant difference between groups (p = 0.03, φ = 0.71). Regarding adverse events due to acupuncture, one patient (14.3%) complained of heaviness after acupuncture. Nothing specific was reported with exercise.
Conclusion: Compared with Ex alone, Ex+TrPAcp may be more effective therapy for older people with CLBP who do not have an exercise habit.

Keywords

Acupuncture therapy, Dry needling, Trigger points, Walking exercise, Low back pain, Chronic pain

Trial registration: This trial was registered at the University hospital Medical Information Network Clinical Trials

INTRODUCTION

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

The world’s population is expected to age rapidly over the next half century, and there are concerns about rising medical and long-term care costs. In Japan, which has the highest aging rate in the world, “low back pain” is a subjective symptom that most older adults, both men and women, complain of, and measures are being taken through national health promotion (Health Japan 21) [1]. The management of pain in older people includes the need for therapeutic drug dose adjustment in accordance with the physiological changes that occur with aging [2] and consideration of the increased risk of falls due to the use of multiple drugs [3], among other factors. Therefore, treatment methods that incorporate both pharmacological and non-pharmacological therapies are strongly recommended [4]. Among non-pharmacological therapies, exercise therapy is recommended as a first-choice therapy because it has been shown to be effective in reducing pain and improving physical function [5-8]. However, musculoskeletal pain can lead to avoidance of physical activity due to exercise-associated fear of pain [9]. In addition, pain catastrophizing can worsen the psychological state and lead to a vicious cycle of further exacerbation and chronic pain [10]. In order for patients to proactively practice exercise therapy, it is important to give them a sense of self-efficacy by making them aware of their pain reduction, which is the most important expectation of patients, in addition to providing patient education to break away from fear-avoidance thinking and communicating well enough to prescribe appropriate exercises [9,11].

On the other hand, previous studies [12,13] reported that regular weekly trigger point acupuncture for older patients with chronic low back pain without neurological deficits significantly reduced pain and improved the degree of daily life impaired by low back pain compared with sham acupuncture, which provides the sensation of acupuncture but does not penetrate the skin, or acupuncture to areas (tender points) other than trigger points. Thus, we hypothesized that acupuncture therapists could complement exercise therapy with trigger point acupuncture to reduce pain, as well as comprehensive and regular patient education and exercise prescription.

The purpose of this study was to investigate whether the combination of exercise and trigger point acupuncture for chronic low back pain in older people who do not exercise regularly can reduce pain and improve pain catastrophizing and psychological state compared to only exercise.

MATERIALS AND METHODS

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

1. Study design

This study was a randomized controlled trial conducted on older adult patients with chronic low back pain. The study was conducted at Teikyo Heisei University (Tokyo, Japan) from September 2020 to January 2021 after approval by the Teikyo Heisei University Ethics Committee (R01-098-1). The clinical trial information of this study has been registered in the UMIN-CTR (ID: UMIN000041398).

2. Patients

Participants who met the following eligibility criteria and did not meet the exclusion criteria were recruited through web advertisements.

1) Inclusion criteria

Age ≥ 65 years.
Chronic musculoskeletal pain for more than 3 months. (NRS ≥ 4, excluding trauma such as fractures and treatments requiring surgery).
No problem with cognitive function.
Person who are not on welfare (public assistance)
Person who can agree even if assigned to control group.
Those who did not allow pharmacotherapy and non-pharmacotherapy changed during the study period. The person must be able to agree not to discontinue any treatment that has been receiving for at least 1 month prior to entering the study.

2) Exclusion criteria

Participation (or plans to participate) in other studies or trials at the same time.
Regular exercise (exercise for 30 min or more at least twice a week for at least 1 year).
Deemed inappropriate for this study by the investigator.

3. Setting

All data were collected at a single center (Teikyo Heisei University).

4. Intervention

The Ex+TrPAcp group received exercise and trigger point acupuncture, while the Ex group received only exercise for 3 months.

Exercise was prescribed according to the methods of Yamada et al. [14] and Hirase et al. [15]. Participants were instructed to wear a pedometer (Yamasa EX-500, Yamasa Tokei Keiki, Ltd., Tokyo, Japan) at all times, except when sleeping or bathing, and to record their daily step count in a diary before bedtime. They were instructed to communicate to the researcher, weekly by e-mail, the number of steps recorded in the daily logbook and any adverse events resulting from the exercise. The researcher calculated the average daily step count for 1 month and provided feedback to the participants twice to increase their average daily step count by 10% compared to the previous month.

Acupuncture was applied to the trigger points, as described in previous studies by Itoh et al. [12,13]. The trigger point was identified from the muscle (quadratus lumborum muscle, iliocostalis lumborum muscle, iliopsoas muscle, gluteus maximus muscle, gluteus medius muscle, gluteus minimus muscle, piriformis muscle, semitendinosus muscle, semimembranosus muscle, soleus muscle) where the trigger point existed based on the movement of the lower back and hip joint and the location of the pain, and the tender point that existed on the taut band was searched by palpation of the muscle. The trigger point was defined as the area where the patient reported symptoms when the point was compressed (Table 1).

Table 1 . Trigger points in both groups at baseline

Muscle	Ex+TrPAcp (N = 7)	Ex (N = 7)
Quadratus Lumborum	10	7
Iliocostalis Lumborum	2	3
Gluteus medius	3	5
Gluteus minimus	0	1
Gluteus maximus	1	3
Iliopsoas	0	2
Piriformis	0	1

Ex+TrPAcp = The group received exercise and trigger point acupuncture; Ex = The group received only exercise.

For acupuncture therapy, disposable stainless steel needles (50 mm, No. 18 or 60 mm, No. 25, Seirin, Japan) were used. The acupuncture manipulations were the retaining needle technique and the single acupuncture technique with a manual. In the retaining needle technique, needles were inserted into the muscle against the trigger point and then left in place for 10 min. After the retaining needle technique was completed, the movement of the lower back and hip joints was checked. If their low back pain was not reduced, the acupuncture needle was inserted again to the target muscle of the detected trigger point, and stimulation was applied to remove it immediately (the single acupuncture technique). Responses to acupuncture stimulation, such as de-qi and local twitch responses, were not considered. The patients were instructed to receive the above trigger point acupuncture therapy approximately once a week for a maximum of 12 sessions. The acupuncture treatments were performed by one acupuncturist who had 15 years of clinical experience.

5. Outcome measures and assessments

The outcomes listed below were assessed before and after the intervention. The number of people who improved after each intervention was determined based on the cutoff values for outcome measures, and the groups were compared. The Ex+TrPAcp group was also assessed for the primary outcome before each acupuncture treatment and was asked about any adverse events caused by the acupuncture treatment. In the Ex+TrPAcp group, those who did not receive acupuncture were assessed retrospectively after the intervention.

6. Primary outcome

1) Numerical Rating Scale

The subjective assessment of pain was conducted using a numerical rating scale (NRS). The NRS is an 11-point scale ranging from “no pain (0)” to “the worst pain imaginable (10),” with higher scores indicating greater pain. In accordance with previous studies, “improvement” was defined as a decrease of two or more points from pre- to post-intervention [16] or a decrease to less than moderate (NRS < 4) after intervention [17].

7. Secondary outcome

1) Roland Morris Disability Questionnaire

The Japanese version of the Roland Morris Disability Questionnaire (RMDQ) [18]. The RMDQ is comprised of 24 items, with higher scores (on a scale of 0-24) indicating a more impaired condition. In accordance with a previous study [19], “improvement” was defined as a decrease of 30% or more from pre- to post-intervention.

2) Hospital Anxiety and Depression Scale

Anxiety and depression were assessed using the Japanese edition of the Hospital Anxiety and Depression Scale (HADS) [20]. The HADS comprises 14 items on two subscales, with higher scores (anxiety: 0-21, depression: 0-21) indicating a higher degree of anxiety or depression. In accordance with a previous study [20], a total score of 11 on each anxiety and depression subscale was used as the cutoff value.

3) Pain Catastrophizing Scale

Catastrophic thoughts related to pain were evaluated using the Japanese version of the Pain Catastrophizing Scale (PCS) [21].

The PCS comprises 13 items, with higher scores (on a scale of 0-52) indicating a higher catastrophic thought. In accordance with previous studies, a score of 30 was used as the cutoff value [22] and “improvement” was defined as a decrease of 6.71 or more [16].

4) EuroQol 5 Dimension

The Japanese version of the EuroQol 5 Dimension (EQ-5D) was used to assess the impact of health-related quality of life [23,24]. The EQ-5D is comprised of five items, with higher scores (on a scale of 0-1) indicating a higher quality of life.

In accordance with a previous study [16], “improvement” was defined as an increase of 0.08 or more from pre- to post-intervention.

5) Pain Self Efficacy Questionnaire

Self-efficacy was assessed using the Japanese version of the Pain Self-Efficacy Questionnaire (PSEQ) [25]. The PSEQ is comprised of 10 items, with higher scores (on a scale of 0-60) indicating higher self-efficacy for pain. In accordance with a previous study [16], “improvement” was defined as an increase of 6.48 or more from pre- to post-intervention.

6) Athens Insomnia Scale

Sleep was assessed using the Japanese version of the Athens Insomnia Scale (AIS) [26]. The AIS is comprised of eight items, with higher scores (on a scale of 0-32) indicating higher insomnia. In accordance with previous studies, a score of 6 or more was used as the cutoff value [26] and “improvement” was defined as a decrease of 6.71 or more [16].

7) Locomo 25

Locomo 25 [27] was used to assess locomotive syndrome. The Locomo 25 is comprised of 25 items, with higher scores (on a scale of 0-100) indicating a decline in physical function. In accordance with previous studies, a score of 16 or more was used as the cutoff value [27] and “improvement” was defined as an increase of 9.31 or more [16].

8. Randomization

Assignment to the Ex+TrPAcp or Ex group was performed randomly based on a computer-generated random number by a researcher who had no contact with the participants.

9. Statistical and analytical methods

For the primary and secondary outcomes, comparisons between groups were made using the contingency table test (chi-square test of independence), and the effect size index (φ coefficient) was calculated. For other group comparisons, contingency tables were tested or normality was tested, and a two-sample t-test or Mann-Whitney’s test was applied, with a significance level of 5%. IBM SPSS Statistics 19 (IBM, Tokyo, Japan) was used for the statistical analysis.

RESULTS

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

1. Participant flow (flowchart)

Fig. 1 shows the flowchart of the participants. The participants were recruited through web advertisements from September to October 31, 2020. Of the 69 patients, 8 and 7 of 15 who met the eligibility criteria and gave consent were randomly assigned to the Ex+TrPAcp group and Ex group, respectively, and 14 were included in the analysis, excluding one who dropped out. The reason for dropping out was that they wanted to refrain from going out during the COVID-19 spread; therefore, they dropped out at the end of the second acupuncture session.

Figure 1.Flowchart. Flowchart showing the process of each stage of a randomized controlled trial (inclusion, allocation to intervention, follow-up, and data analysis).

2. Baseline data

Table 2 shows the participant characteristics at baseline. There was a significant difference between the Ex+TrPAcp and Ex groups in the RMDQ and PSEQ scores. None of the patients with HADS-A and HADS-D exceeded the cutoff value (11 or more) for definitive diagnosis. The PCS exceeded the cutoff value (30 or more) for catastrophic thinking for 1 in the Ex group and 2 in the Ex+TrPAcp group. AIS was above the cut-off value (6 or more) for sleep disturbance in four patients (57.1%) in the Ex group and six patients (85.7%) in the Ex+TrPAcp group. Locomo 25 was above the cutoff value (16 or more) for being considered to have locomotive syndrome in three (42.9%) in the Ex group and seven (100%) in the Ex+TrPAcp group.

Table 2 . Baseline characteristics of patients

Characteristics	Ex+TrPAcp (N = 7)	Ex (N = 7)	p-value
Age (yr)^a	71.00 ± 4.47	70.29 ± 5.35	0.79
Sex, no. (%)
Male (n)	4 (57.14)	5 (71.43)	1.00
Female (n)	3 (42.86)	2 (28.57)
Height (cm)^a	165.57 ± 8.08	161.14 ± 11.20	0.41
Weight (kg)^a	65.61 ± 9.33	61.06 ± 13.79	0.48
Body-fat percentage (%)^a	27.99 ± 5.06	24.24 ± 4.29	0.16
Body-mass index^a	23.87 ± 2.10	23.09 ± 3.26	0.60
No previous acupuncture experience (n)	4 (57.14)	1 (14.29)	0.27
Duration of pain (month)^b	120.00 (36.00-180.00)	84.00 (24.00-516.00)	0.85
Number of trigger points^b	2.00 (2.00-5.00)	2.00 (1.00-2.00)	0.34
Numerical Rating Scale^b	5.00 (4.00-7.00)	5.00 (4.00-6.00)	0.89
RMDQ score^a	10.43 ± 2.30	5.71 ± 3.30	0.01
HADS
HADS-A^a	3.86 ± 1.77	3.14 ± 3.24	0.62
HADS-D^a	5.57 ± 2.15	3.29 ± 2.69	0.10
PCS^a	28.43 ± 7.59	20.14 ± 10.06	0.11
EQ-5D score^b	0.96 (0.84-0.96)	0.91 (0.73-0.96)	0.47
PSEQ^a	33.14 ± 12.76	47.29 ± 3.68	0.03
AIS^a	6.86 ± 2.04	5.86 ± 3.89	0.56
Locomo 25^b	27.00 (18.00-34.00)	12.00 (8.00-40.00)	0.12

^aMeans ± SD, ^bMedian (IQR).

Ex+TrPAcp = The group received exercise and trigger point acupuncture; Ex = The group received only exercise; RMDQ = The Japanese version of the Roland Morris Disability Questionnaire; HADS = The Japanese edition of the Hospital Anxiety and Depression Scale; HADS-A = The Japanese edition of the Hospital Anxiety and Depression Scale -anxiety; HADS-D = The Japanese edition of the Hospital Anxiety and Depression Scale - depression; PCS = The Japanese version of the Pain Catastrophizing Scale; EQ-5D = The Japanese version of the EuroQol 5 Dimension; PSEQ = The Japanese version of the Pain Self-Efficacy Questionnaire; AIS = The Japanese version of the Athens Insomnia Scale.

3. Implementation of acupuncture

In the Ex+TrPAcp group, five patients (71.4%) received acupuncture 12 times, the maximum allowable, one patient (14.3%) received acupuncture 11 times, and one patient (14.3%) never received acupuncture. The reason the two patients did not receive acupuncture was that the treatment date did not match. Fig. 2 shows the survival curve for the cumulative low back pain (NRS ≥ 4) rate during the follow-up period in seven patients in the Ex+TrPAcp group: three patients reported improvement in their back pain at week 3, and one patient each at weeks 5, 6, and 8.

Figure 2.Survival curve for the rate of cumulative low back pain (NRS ≥ 4) in the Ex+TrPAcp group (n = 7) during the follow-up period. The figure shows the survival curve for the rate of cumulative low back pain (NRS ≥ 4) in the Ex+TrPAcp group over the intervention period. The vertical axis shows the rate of cumulative low back pain, and the horizontal axis shows the time course. The NRS score was assessed before each acupuncture session. However, patient 7, who did not receive acupuncture, was assessed retrospectively after the intervention period. NRS = Numerical Rating Scale; Ex+TrPAcp = The group received exercise and trigger point acupuncture.

4. Implementation of the exercise

There was a significant difference in the mean number of steps per day during the first month of the intervention: 4,352 ± 2,109 in the Ex group and 6,447 ± 1,158 in the Ex+TrPAcp group. In the month after receiving feedback to increase by 10% from this 1-month average daily step count, the Ex group had 4,705 ± 1,946 and the Ex+TrPAcp group 6,541 ± 1,601, and in the month after receiving feedback to increase another 10%, the Ex group had 4,998 ± 1,945 and the Ex+TrPAcp group 6,909 ± 2,050. The average number of steps per day increased by 22.3% in the Ex group and 9.1% in the Ex+TrPAcp group during the last month compared to the first month. In addition, two participants (28.6%) in both the Ex and Ex+TrPAcp groups were able to fully carry out the exercise (increase the average daily step count by at least 10% from the previous month).

5. Outcomes and estimation

Table 3 shows the results of the comparison between the groups.

Table 3 . Comparison of participants with improved primary and secondary outcomes after the intervention

Outcome	Ex+TrPAcp (N = 7)	Ex (N = 7)	Effect size (p-value)
Primary outcome
Number of patients whose NRS decreased by more than 2 or less than 4, no./total no. (%)	6/7 (85.71)	1/7 (14.29)	φ = 0.71 (p = 0.03)
Secondary outcomes
Number of patients whose RMDQ decreased by 30% or more, no./total no. (%)	5/7 (71.43)	2/7 (28.57)	φ = 0.43 (p = 0.29)
Number of patients who decreased by 6.71 or more among those judged to have catastrophic thoughts in PCS, no./total no. (%)	2/2 (100.00)	0/1 (0.00)	φ = 1.00 (p = 0.33)
ΔEQ-5D of ≥ +0.08, no./total no. (%)	3/7 (42.86)	1/7 (14.29)	φ = 0.32 (p = 0.56)
ΔPSEQ of ≥ +6.48, no./total no. (%)	3/7 (42.86)	1/7 (14.29)	φ = 0.32 (p = 0.56)
Number of patients whose AIS decreased from 6 points or more to 1.90 or more, no./total no. (%)	3/6 (50.00)	1/4 (25.00)	φ = 0.25 (p = 0.57)
Number of patients whose Locomo 25 decreased from 16 points or more to 9.31 or more, no./total no. (%)	3/7 (42.86)	0/3 (0.00)	φ = 0.43 (p = 0.48)

Ex+TrPAcp = The group received exercise and trigger point acupuncture; Ex = The group received only exercise; NRS = Numerical Rating Scale; RMDQ = The Japanese version of the Roland Morris Disability Questionnaire; PCS = The Japanese version of the Pain Catastrophizing Scale; EQ-5D = The Japanese version of the EuroQol 5 Dimension; PSEQ = The Japanese version of the Pain Self-Efficacy Questionnaire; AIS = The Japanese version of the Athens Insomnia Scale; Φ = phi coefficient.

1) Primary outcome

There was a significant difference in the number of patients who decreased their NRS, the primary outcome, by more than 2 or less than 4 between the two groups: 1 (14.3%) in the Ex group and 6 (85.7%) in the Ex+TrPAcp group. The φ coefficient, which is an index of the effect size, was 0.71.

2) Secondary outcome

The secondary outcome, RMDQ score, decreased by 30% or more after the intervention compared to before the intervention in two (28.6%) in the Ex group and five (71.4%) in the Ex+TrPAcp group. Among those judged to have catastrophic thoughts in the PCS, the number of those who decreased by 6.71 or more after the intervention compared to before the intervention was 0 (0%) in the Ex group and 2 (100%) in the Ex+TrPAcp group. The EQ-5D increased by 0.08 or more after the intervention compared to before the intervention in one patient (14.3%) in the Ex group and three (42.9%) in the Ex+TrPAcp group. The PSEQ increased by more than 6.48 after the intervention compared to before the intervention in one patient (14.3%) in the Ex group and three (42.9%) in the Ex+TrPAcp group. Of those with AIS of 6 points or more before the intervention, AIS of one patient (25.0%) in the Ex group and three (50.0%) in the Ex+TrPAcp group decreased by 1.9 points or more after the intervention. Of those who scored 16 or more points on the Locomo 25 before the intervention, the scores of 0 (0%) in the Ex group and three (42.9%) patients in the Ex+TrPAcp group decreased by 9.31 or more after the intervention. No significant differences were observed in any of the secondary outcomes.

6. Harms

Regarding adverse events due to acupuncture, one patient (14.3%) complained of heaviness after acupuncture. Nothing specific was reported with exercise.

DISCUSSION

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

1. Data Interpretation

Regular intervention of trigger point acupuncture up to 12 times in 3 months in addition to exercise for older people who do not exercise regularly and chronic low back pain showed significant improvement in the subjective intensity of low back pain compared with the intervention of exercise only.

Trigger points are thought to be sensitization sites for polymodal receptors [28], and we suggest that acupuncture stimulation of sensitized polymodal receptors activates the analgesic system, reduces muscle tension, and improves blood flow, thereby reducing pain. As for the psychological state and physical function, few participants showed abnormal values in outcome measures. However, the percentage of patients who showed a tendency toward improvement in each item was higher in the Ex+TrPAcp group than in the Ex group, suggesting that the benefits may be equal to or greater than those of exercise alone.

The average number of daily steps counted during the intervention period was approximately 2,000 steps higher in the Ex+TrPAcp group (approximately 6,400-6,900 steps) than in the Ex group (approximately 4,300-4,900 steps). This suggests that “going out to receive acupuncture therapy” itself became a motivation for behavioral change and physical activity. In addition, its impact might be greater than the number of steps increased by the exercise in this study. The steps increased by 645 steps on average in the Ex group and 462 steps on average in the Ex+TrPAcp group.

Therefore, we conclude that the addition of trigger point acupuncture can complement exercise therapy when prescribing exercise therapy for older people with chronic low back pain who do not have an exercise habit.

2. Generalizability

The total cost of acupuncture treatment was calculated to be JPY 30,439-40,571 per patient, based on the average amount paid by patients for acupuncture treatments in Japan (JPY 3,001-4,000) [29]. In the Ex+TrPAcp group, the increase in Quality-adjusted life years (QALYs) from pre- to post-intervention was 0.045 (0; death, 1; perfect health), indicating that the cost of increasing one QALY by acupuncture was JPY 676,422-901,578. This amount is much lower than the willingness to pay JPY 5,000,000 per QALY in Japan [30], indicating that trigger point acupuncture is cost-effective for older people with chronic back pain. As shown in Fig. 2, the effect of acupuncture appeared from the third week after the start of the intervention, and by the eighth week, low back pain had improved in all participants who received acupuncture regularly, suggesting that the intervention period and frequency were appropriate.

3. Limitations

First, because we did not set up an acupuncture group such as the one using sham acupuncture for blinding, the results obtained may include thought bias and the Hawthorne effect. In addition, in this design, it is uncertain whether the effect is due to acupuncture only, the increased amount of exercise performed, or a combination of the two. Therefore, it is necessary to design a study that takes these factors into account. Second, during the period of this study, the coronavirus disease 2019 infection was widespread, and the amount of physical activity decreased due to refraining from going out, which may have affected the effect of exercise therapy. In addition, for the same reason, we did not prescribe exercise therapy that requires face-to-face or group instruction; therefore, its effectiveness is unknown. There was a difference in the average number of steps per day between the groups; however, since the average number of steps per day before the intervention was not known, the possibility that this was not due to the intervention cannot be denied. Third, since we did not have a follow-up period, we were not able to confirm how long the effect will last or whether the exercise therapy will be continued by patients. Fourth, due to the small number of patients in this study, the differences between groups observed at baseline and the effect of the two patients who did not receive acupuncture on the analysis are unknown. Therefore, future studies with a larger sample size should be designed based on the results of this study.

CONCLUSIONS

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

In older adults with chronic low back pain and no exercise habit, regular intervention of trigger point acupuncture up to 12 times in 3 months in addition to exercise therapy showed significant improvement in the subjective intensity of low back pain compared with exercise therapy alone, indicating that it may complement exercise therapy.

ACKNOWLEDGEMENTS

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

We sincerely thank Tahara Iori, Ishibashi Shinya, and Taniguchi Hiroki, who graciously collaborated with us in conducting this study. We would like to thank Editage (www.editage.com) for English language editing.

FUNDING

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

This study was conducted with the assistance of Teikyo Heisei University Research Encouragement Grant (19THU006).

AUTHORS' CONTRIBUTIONS

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

YM, SM, HW, NY, KII, and KIT conceived the study design and were involved in data interpretation. YM, HW, and NY represent data curation. YM obtained the funding acquisition. SM contributed to the data analysis. All authors critically edited the drafts of this manuscript and approved the final version of the manuscript for publication.

CONFLICT OF INTEREST

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INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

The authors declare no conflict of interest.

References

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Abstract
INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS
FUNDING
AUTHORS' CONTRIBUTIONS
CONFLICT OF INTEREST
References

Ministry of Health, Labour and Welfare. Comprehensive survey of living conditions (2019). 2019. Available at: https://www.mhlw.go.jp/toukei/saikin/hw/k-tyosa/k-tyosa19/dl/06.pdf [Date accessed: February 20, 2021].
Abdulla A, Adams N, Bone M, Elliott AM, Gaffin J, Jones D, et al. Guidance on the management of pain in older people. Age Ageing 2013;42 Suppl 1:i1-57.
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