Lumbar spinal stenosis (LSS) is a common cause of pain and difficulty walking in elderly individuals. LSS is characterized by the constriction of the lumbar spinal canal and/or neural foramina which can compress the spinal nerve roots. Acquired LSS primarily arises from degenerative changes in the facet joint, ligament flavum, disc, and bone [1,2]. The underlying mechanisms of LSS is not fully understood. One theory suggests that osteophytes and adjacent tissue hypertrophy compress small arterioles, causing nerve ischemia [3]. Furthermore, LSS may impede proper venous drainage, resulting in increased venous pressure, accumulation of toxic metabolic byproducts, and potential damage to nerve roots [3].

Typical complaints of patients with degenerative LSS include back pain and discomfort in the lower extremities, resulting in neurogenic claudication. The major symptoms are exacerbated by walking or lumbar extension and alleviate during spine stabilization or lumbar flexion [3]. A history taking, physical examination, and cross-sectional imaging, such as magnetic resonance imaging or computed tomography, are generally used to diagnose LSS.

Pharmacopuncture and acupotomy are traditional integrative interventions commonly used in East Asian countries, including China and the Republic of Korea. Pharmacopuncture involves the injection of pharmacopuncture solutions extracted, refined, or diluted from animal-derived materials, herbal medicines, and other natural products. This treatment achieves therapeutic effects by injecting solutions into specific acupuncture points, including the Ashi points, muscle meridians, and intra-subcutaneous areas. This technique is widely utilized for managing musculoskeletal disorders in clinical practice and is expected to induce the synergistic effect of medicinal extract and acupuncture stimulation [4,5]. Study of 4 years of clinical data from Korean Medicine hospitals and clinics found that 98.6% of 33,145 inpatients and 77.6% of 373,755 outpatients received pharmacopuncture therapy [5]. According to survey among Korean Medicine doctors, the most common pharmacopuncture solutions used were bee venom, Hominis placenta, and herbal extracts such as Hwangryunheadok-tang and Jinseng [6]. Moreover, the majority of Korean Medicine doctors (94.3%) use pharmacopuncture as a treatment modality for managing LSS [7]. Acupotomy, also known as mini scalpel needle or needle-knife, combines acupuncture with synechotomy. Because of its sharp and flat blade featured at the tip of the needle, acupotomy is used for chronic musculoskeletal pain disorders by applying strong stimulation to the tissues affected by excessive tension, adhesions, fibrosis, or scar formation [8]. This therapeutic technique is widely utilized in clinical settings across East Asia, and several studies have shown that acupotomy has beneficial effects in LSS treatment [9,10].

In Korean Medicine clinical practice, multiple interventions, including acupuncture, pharmacopuncture, acupotomy, and physical therapy, are commonly employed in combination to treat patients with LSS, rather than relying solely on pharmacopuncture or acupotomy [7]. Nevertheless, pragmatic studies on combining pharmacopuncture, acupotomy, and conventional Korean Medicine treatments (CKMT) for LSS are lacking. Therefore, we designed this pragmatic randomized controlled trial to evaluate the effect of combining pharmacopuncture therapy and acupotomy in patients with LSS.

1. Study design

This study was designed as a pragmatic, assessor-blinded, randomized, controlled clinical trial with two parallel arms. A trial flowchart is shown in Fig. 1. The study was approved by the Institutional Review Board (IRB) of the Pusan National University Korean Medicine Hospital (PNUKMH) on 10 Feb 2023 (PNUKHIRB 2023-01-004). This clinical research protocol was based on the content registered and approved by the Clinical Research Information Service of the Republic of Korea (KCT0008557). This study protocol was established in accordance with the Standards for Reporting Interventions in Clinical Trials of Acupuncture and the Standard Protocol Items: Recommendation for Interventional Trials [11,12].

Figure 1. Study flowchart. VAS = visual analog scale; ZCQ = Zurich Claudication Questionnaire; RMDQ = Roland-Morris disability questionnaire; EQ-5D5L = EuroQol 5-dimension 5-level questionnaire; PGIC = Patients’ Global Impression of Change; AE = adverse events.

A total of 104 participants who met the eligibility criteria will be recruited from PNUKMH. After allocation, 14 visits over 14 weeks, including 6 weeks of treatment and 4 and, 8 weeks of follow-up, will be conducted according to scheduled appointments (Table 1). If concurrent medications (e.g., non-steroidal, anti-inflammatory drugs) or treatments (e.g., acupuncture, cupping, or injections) that may affect LSS are identified during screening, a wash-out period of at least 2 weeks will be required before participating.

VAS = visual analog scale; ZCQ = Zurich Claudication Questionnaire; RMDQ = Roland-Morris disability questionnaire; EQ-5D5L = EuroQol 5-dimension 5-level questionnaire; PGIC = Patients’ Global Impression of Change..

&md=tbl&idx=1' data-target="#file-modal"">Table 1

Schedule of enrollment, interventions, and assessments.

		Study period
		Treatment phase			Follow-up phase
Visit	Screening	V1	V2-V11	V12	V13	V14
Week	–2-0W	1 W	1-6 W	6 W	10 W	14 W
ENROLLMENT
Informed consent	√
Inclusion/exclusion criteria	√
Demographic characteristics	√
Medical history	√
Lab test	√			√
L-spine CT/MRI	√
Physical examination	√
Vital sign	√	√	√	√	√	√
Random allocation		√
Interventions		√	√	√
ASSESSMENTS
VAS	√	√		√	√	√
ZCQ		√		√	√	√
RMDQ		√		√	√	√
Maximum walking distance		√		√	√	√
EQ-5D index		√		√	√	√
PGIC				√		√
Safety assessment		√	√	√	√	√

VAS = visual analog scale; ZCQ = Zurich Claudication Questionnaire; RMDQ = Roland-Morris disability questionnaire; EQ-5D5L = EuroQol 5-dimension 5-level questionnaire; PGIC = Patients’ Global Impression of Change..

2. Participants

1) Inclusion criteria

Individuals who meet the following criteria will be included in this study: (1) Aged 40 years and older but younger than 75 years; (2) Confirmed to have lumbar spinal stenosis on imaging examination (CT or MRI); (3) Pain or discomfort in the lumbar, lower limb, or buttock ≥ 40 mm (on a 0 to 100 mm VAS); (4) Individuals with clinical manifestations of lumbar spinal stenosis, such as neurogenic claudication or symptoms that change with posture; (5) Individuals who have received a final diagnosis of lumbar spinal stenosis based on comprehensive physical examination, medical history, and imaging examination results; (6) Individuals who voluntarily participated after being informed of the study purpose and procedure and provided written informed consent.

2) Exclusion criteria

Participants who meet the following characteristics will be excluded: (1) Individuals diagnosed with congenital or developmental lumbar spinal stenosis; (2) Individuals diagnosed with spinal disorders other than lumbar spinal stenosis may cause lower back and radiating pain (e.g., vertebral tumors, Cauda equina syndrome, spinal infections, and ankylosing spondylitis); (3) Individuals with major structural problems in the spine may experience lower back and radiating pain (e.g., acute thoracolumbar fractures, spinal dislocation, and spondylolisthesis); (4) Individuals with a history of spinal surgery, such as spinal fusion or laminectomy; (5) Individuals taking anticoagulants or antiplatelet drug, or with bleeding disorders that may affect hemostasis; (6) Individuals with acupuncture hypersensitivity, metal allergies, severe atopic dermatitis, keloid skin, or other skin hypersensitivity; (7) Chronic diseases (e.g., chronic kidney disease, diabetic neuropathy, stroke, myocardial infarction, dementia, and epilepsy) may affect treatment outcomes or research results; (8) Individuals taking medications (e.g., steroids, immunosuppressants) that may affect treatment outcomes or research results; (9) Pregnant or lactating women or those planning to become pregnant; (10) Other individuals deemed inappropriate by the researchers.

3) Sample size

A pilot study (n = 40) [13] was conducted to compare the add-on effects of pharmacopuncture treating patients with LSS. The intergroup difference in the mean change of VAS for low back pain between the experimental group (pharmacopuncture therapy + CKMT) and the control group (CKMT) was 12.8 (95% confidence interval 2.2 to 23.3) at the primary endpoint, which is immediately after the 5 weeks treatment. In a similar study (n = 146) [14], the effectiveness of the experimental group (acupotomy) and the control group (acupuncture) was compared. The between-group difference in the mean change in VAS for low back and/or leg pain was 11.13 (95% confidence interval –17.49 to –4.77) at the primary endpoint, which was at 4 weeks post-randomization (after 2 weeks post-intervention). In this clinical trial, a significance level (α) of 5% was used, with a power (1-β) of 80%. Considering a 30% interaction effect between the two treatments (pharmacopuncture therapy and acupotomy), the difference in the effect of the change in the VAS score between the two groups was assumed to be 15, with a standard deviation of 25. Based on the equation for sample size calculation, under an allocation ratio of 1:1, a significance level of 5%, and a power of 80%, 43.61 participants in each group are required. Considering a dropout rate of 15%, 104 participants will be finally recruited.

4) Randomization and allocation

A block randomization procedure will be used to randomly allocate 104 participants to the experimental group and the control group. An independent statistician will generate the randomization sequence using SAS^® Version 9.4 (SAS Institute Inc., Cary, NC, USA). The block size will also be set by the independent statistician, ensuring that it remains confidential and will not be disclosed until the completion of the trial. Once the randomization sequence has been generated, it will be sealed in opaque sealed envelopes and managed by an independent blinded manager and principal investigator. When a participant is screened and meets the inclusion criteria, the envelope will be opened, and a random number will be assigned.

5) Blinding

This clinical trial was designed as an assessor-blinded study. The independent assessor will be blinded to group allocation and patient information throughout the study. Pharmacopuncture and acupotomy will be performed only in the experimental group. Therefore, it is not possible to blind the practitioner and participants to group allocation. However, to minimize bias caused by intervention practitioners, “pharmacopuncture therapy with acupotomy” and “CKMT” will be performed by a separate practitioner. CKMT practitioners will remain unaware of the group allocation and will provide the same CKMT to all participants. This implementation will prevent practitioners from showing preferential treatment or guidance towards the experimental group, thus ensuring objectivity and reliability of the research results.

3. Interventions

Pharmacopuncture and acupotomy will be administered by a Korean Medicine Doctor with over 10 years of clinical experience in pharmacopuncture and acupotomy. Clinical experts with over 2 years of experience in Korean Medicine will perform the CKMT. Pharmacopuncture therapy and CKMT will be administered twice weekly, and acupotomy will be administered 1-2 times weekly. Practitioners will selectively combine and apply the following methods, considering clinical features, such as lesions on images, pain complaint areas, and tenderness on the lumbar region, lower limb, or buttock. All treatment details will be recorded on a case report form.

1) Pharmacopuncture therapy

This pragmatic study will establish a pool of different extracts, including bee venom, bamboo salt, and Hominis placenta, for pharmacopuncture therapy. This study also allows flexibility in the intervention by including different depths and needle sizes. Bee venom pharmacopuncture will be the primary treatment in early sessions. If a patient is allergic to bee venom or if pain persists despite bee venom pharmacopuncture, bamboo salt pharmacopuncture can be used as an alternative treatment. In cases where pain improves after the initial bee venom pharmacopuncture therapy or in the later stages of sessions, Hominis placenta pharmacopuncture will be the main treatment, especially for degenerative spine lesions. The pool of pharmacopuncture acupoints will consist of EX-B2 (L1-5), GV3, GV4, GV5, BL22, BL23, BL24, BL25, BL26, BL53, BL54, GB30, GB31, GB34, ST36, ST40, LR3, and Ashi points.

2) Acupotomy

Acupotome will be selected from sterile, disposable, stainless steel 0.60 × 50 mm or 0.75 × 80 mm (DongBang Acupuncture Inc., Gyeonggi-do, Republic of Korea) (Fig. 2), considering the patient’s symptoms, post-treatment course, and discomforts. Before treatment, the skin at the site will be disinfected with 10% povidone-iodine for aseptic manipulation. After the manipulation is completed, the treatment areas will be sterilized and dressed using bandages. The subject will receive 10 min of ice pack compression and education on infection prevention. Acupotomy will be selectively performed using three methods, including ultrasound guidance, depending on the target tissue. Ultrasound-guided acupotomy, including the out-of-plane or in-plane needle approaches, will be performed on the spinal area. The buttocks will be treated with acupotomy based on the areas of pain and tenderness in the sacrum. Longitudinal-axis scan with out-of-plane needle approach (Fig. 3A): The probe will be placed longitudinally, slightly towards the facet joint beside the spinous processes. The acupotome will be inserted between the upper and lower facet joints from outside of the probe, with the tip directed towards the base of the transverse process. The practitioner will stimulate the para-nerve root area (Fig. 3B) and remove the acupotome if the patient complains of a tingling sensation. Transverse-axis scan with in-plane needle approach (Fig. 4A): The probe will first be placed on the marked spinous process along its longitudinal axis. Once the midlines of the upper and lower spinous processes are confirmed, the probe will be rotated 90° and placed transversely. The probe will be placed transversely on the stenotic lesions. The acupotome will be inserted parallel to the probe. A clinical expert will obliquely stimulate the multifidus muscle and facet joint multiple times (Fig. 4B) under ultrasound guidance. Buttock approach: Acupotomy will be performed at the buttock acupoints, including BL53, BL54, and GB30.

Figure 2. Front and side view of acupotome.

Figure 3. Longitudinal-axis scan with out-of-plane needle approach. (A) The para-nerve root area is located in the hyperechoic area between the hypoechoic facet joints. The asterisk indicates the tip of acupotome. (B) The nerve roots in the lumbar region are located in the intervertebral foramina, which are openings in the vertebrae that allow the nerves to exit the spinal cord. The acupotome will be performed using ultrasound guidance to precisely stimulate the para-nerve root area.

Figure 4. Transverse-axis scan with in-plane needle approach. (A) The multifidus muscle appears as a gray band on either side of the hypoechoic spinous process on ultrasound. The facet joint is located at the lateral aspect of the vertebral body. The facet joint appears as a round, hypoechoic structure on ultrasound, with the articular surfaces appearing as hyperechoic and the joint space appearing as anechoic. The short arrows indicate the acupotomy positions that target the multifidus muscle and facet joint, respectively. (B) The multifidus muscle is a deep muscle that runs along the posterior surface of the vertebrae, and the facet joint is located between the superior and inferior articular processes. The acupotome will be obliquely inserted to stimulate the multifidus muscle and the facet joint, respectively.

3) Conventional Korean Medicine treatment

CKMT will be performed as shown (Table 2). The patient will be placed in the prone position, and cupping will be applied to the lower back and pelvis for 5 min. Compulsory main acupoints will include bilateral EX-B2 (L1-5), corresponding to the level of the LSS. Individualized auxiliary acupoints will be selected from the suggested acupoint pool based on the patient’s clinical features. These include the GV3, GV4, GV5, BL22, BL23, BL24, BL25, BL26, BL53, BL54, GB30, GB31, GB34, ST36, ST40, LR3, and Ashi points. Considering the post-treatment course, 0.25 × 40 mm or 0.35 × 60 mm sterile, disposable, stainless steel (DongBang Acupuncture Inc., Gyeonggi-do, Republic of Korea) will be selectively used under an infrared apparatus (Omega-302, ENS Tech., Gyeonggi-do, Republic of Korea). The needles will remain in situ for 15 min and be inserted to a 5-55 mm depth with manual de qi sensation. An ES-160 device (6 V, 160 mA, ITO Co., Ltd., Japan) will be used at a constant frequency of 2.0 Hz for electroacupuncture. Electrodes will be placed at the bilateral EX-B2 points.

Table 2

Standards for reporting interventions in clinical trials of acupuncture for CKMT.

Item	Detail	Contents
1. Acupuncture rationale	1a) Style of acupuncture	Korean Medicine
	1b) Reasoning for treatment provided	Based on the clinical practice guidelines and a textbook of acupuncture
	1c) Extent to which treatment was varied	Most treatments will be selected individually according to the patient’s symptoms and conditions
2. Details of needling	2a) Number of needle insertions per subject per session	10-20 needles will be used.
	2b) Names of points used	Compulsory main acupoints: bilateral EX-B2 (L1-L5) Individualized auxiliary acupoints: GV3, GV4, GV5, BL22, BL23, BL24, BL25, BL26, BL53, BL54, GB30, GB31, GB34, ST36, ST40, LR3 and Ashi points
	2c) Depth of insertion	Between 0.5 cm and 5.5 cm
	2d) Response sought	De-qi sensation or local muscle twitch response
	2e) Needle stimulation	Both of manual and 2.0 Hz electrical stimulation will be applied within individual pain thresholds.
	2f) Needle retention time	15 min
	2g) Needle type	Sterile, disposable, stainless steel 0.25 mm × 40 mm or 0.35 mm × 60 mm (DongBang Acupuncture Inc., Gyeonggi-do, Republic of Korea)
3. Treatment regimen	3a) Number of treatment sessions	12 sessions
	3b) Frequency and duration of treatment sessions	2 sessions per week for 6 weeks
4. Other components of treatment	4a) Details of other interventions administered to the acupuncture group	Cupping and Infrared ray apparatus
	4b) Setting and context of treatment	Information on the treatment will be provided to the patients.
5. Practitioner background	5) Description of participating acupuncturists	Three clinical experts with over 2 years of experience in Korean medicine
6. Control or comparator interventions	6a) Rationale for the control or comparator in the context of the research question	Same acupuncture treatment will be applied to the control and experimental groups.
	6b) Precise description of the control or comparator	Same acupuncture treatment will be applied to the control and experimental groups.

4) Cointervention

Invasive treatments (e.g., injection, surgical operation), medication (e.g., non-steroidal anti-inflammatory drugs), and other Korean Medicine treatments (e.g., acupuncture, pharmacopuncture, or acupotomy), other than the treatment provided, will not be allowed during participation. Drugs typically used to treat underlying diseases that are not expected to affect the study’s results will be allowed at the researcher’s discretion. All details of the cointerventions will be recorded in a case report form.

3. Primary outcome measure

The primary outcome is the mean change in the 100-mm VAS score at the primary endpoint (week 6) after the end of treatment, compared with that at baseline (week 1). The 100-mm VAS, where 0 indicates no pain and 100 indicates the most severe pain [15], will be used to measure pain or discomfort in the lumbar region, lower limbs, or buttocks. All assessments will be performed by independent researchers unrelated to the intervention.

4. Secondary outcome measure

1) Pain

The mean change in the 100-mm VAS score from baseline to weeks 10 and 14 will be measured to evaluate pain in the follow-up phase at 4- and 8-week post-treatment, respectively.

2) Minimal clinically important difference (MCID)

MCID is the smallest change in a score that is considered to be clinically meaningful. Proportion of patients who achieve the pre-defined clinically important difference is the percentage of patients who have a decrease in their VAS score of at least 15 mm, or who achieve a percentile decrease of 30% or 50% compared to their baseline score [16].

3) Function (Zurich Claudication Questionnaire, Roland-Morris disability questionnaire, self-reported maximum walking distance)

The Zurich Claudication Questionnaire (ZCQ) is an evaluation tool for the symptoms and functions of patients with LSS and consists of the following three domains: symptom severity, physical functional status, and postoperative satisfaction [17]. Since Pharmacopuncture therapy/acupotomy and CKMT are not surgical interventions, only two parts of the ZCQ, i.e., symptom severity and physical functional status, will be adopted. The ZCQ symptom domain contains seven questions: pain, sensory abnormalities, weakness, and balance disorders. The scores ranged from 1 to 5; the higher the score, the more severe the symptoms. The ZCQ function domain includes questions about the average walking distance, outdoor walking, grocery shopping, house walking, and toilet inconvenience. The scores ranged from 1 to 4; the higher the score, the more severe the symptoms. The Korean version of the ZCQ, verified to be transculturally equivalent, will be used in this study [18].

The Roland-Morris disability questionnaire (RMDQ) consists of 24 items that assess the level of pain-related functional disability caused by lumbar pain. Each item scored 0 if left blank or 1 if endorsed. The total RMDQ score ranged from 0 to 24, with higher scores indicating higher levels of pain-related disability [19].

Self-reported walking capacity is the distance (meter) a patient can walk without rest. This distance will be calculated by multiplying the maximum walking time by the walking speed according to the age in Koreans (15-49 years [66.67 m/min], 50-64 years [56.67 m/min], 65-74 years [47.00 m/min] and over 75 years [41.83 m/min]) [20].

4) EuroQol 5-dimension 5-level questionnaire (EQ-5D5L)

The participant’s QOL assessment will be performed using the validated Korean version of the EQ-5D5L [21]. Participants will be asked to check the most appropriate sentence for five items related to their condition (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) [22].

5) Patients’ Global Impression of Change (PGIC)

The PGIC is a tool used to evaluate global assessment before and after an intervention. Participants will choose one of seven categories for the degree of improvement before and after treatment (very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse) [23].

6) Adverse event (AE) and safety

Any AE will be recorded at every visit, including the time of occurrence, end time, severity, relevance to the intervention, and details in the case report form. In the case of sweet bee venom, to minimize AE such as itching, redness, and swelling, the dose will be gradually increased while checking the post-treatment responses of the patient. The severity of AE is classified into five grades according to the World Health Organization (WHO) guidelines. AE that does not correspond to the WHO guidelines will be evaluated using Spilker’s three-step classification method [24]. The causal relationship between the intervention and AE will be evaluated using a six-stage classification. If an AE occurs, the researchers will provide appropriate examinations and treatments according to the compensation rules. If a severe AE occurs, the researcher will notify the principal investigator (PI) who will report to the IRB to determine whether the subject should be excluded. At screening and visit 12 (after 6 weeks), blood tests will be performed that include the following items: erythrocytes, leukocytes, hemoglobin, hematocrit, platelets, prothrombin time, erythrocyte sedimentation rate, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, blood urea nitrogen, creatinine, and C-reactive protein.

5. Statistical methods

All analyses will be performed using SAS^® Version 9.4 (SAS Institute Inc., Cary, USA) by an independent statistician, and statistical significance will be set to p < 0.05 (two-tailed). We will use the last observation carried forward method for handling missing values. The full analysis set (FAS), intent-to-treat, and per-protocol sets will be included in the analysis set. The FAS will include individuals who have undergone assessment at least once following randomization and will be utilized for the primary analysis. To be included in the per-protocol set, participants must complete the trial without any significant deviations from the study protocol and should receive a minimum of ten or more (≥ 80%) treatment sessions.

Descriptive statistics for demographic characteristics, such as sex, age, medical history, and medication history, are presented as means and standard deviations for continuous variables. Subsequently, an analysis will be conducted using either the independent t-test or the Wilcoxon rank-sum test. Frequencies and percentages will be reported for categorical variables, and the chi-squared test or Fisher’s exact test will be used.

The primary outcome will be analyzed using an analysis of covariance, with baseline VAS as a covariate and each treatment group as a fixed factor. If clinically significant differences are found in terms of demographic characteristics, covariates could be added to adjust for these differences. The secondary outcome will be analyzed in the same way as the primary outcome measure. To assess the trends of the outcome variables in the two groups over time, repeated measures analysis of variance will be conducted. The safety set will include all AEs reported during the study period and be presented as descriptive statistics. Subgroup analysis can be performed based on sex, age, morbidity period, spinal stenosis level, and pharmacopuncture therapy or acupotomy.

6. Data collection and monitoring

Data collection and management procedures for this clinical trial will be carried out exclusively by authorized investigators, including clinical research coordinators. The confidentiality of all data and documents collected during the clinical trial will be protected, and the anonymity of trial participants will be rigorously maintained. At the completion of the study, all documents will be appropriately disposed of or preserved in adherence to the guidelines specified by the IRB. Regular initial and interim monitoring sessions will be conducted to maintain the study’s integrity and consistency.

7. Withdrawal and dropout

The participant may decline further participation due to personal reasons or dissatisfaction with treatment. Participants will be dropped out from the study If a significant protocol violation of the criteria for cointervention or eligibility is discovered during the trial. If invasive treatment or surgery is necessary due to worsening of LSS, the PI may discontinue the subject. If the withdrawal or dropout is due to an adverse event related to the research intervention, the subject will be provided with appropriate treatment until the symptoms resolve and the condition improves.

8. Ethics

This study will be conducted based on the principles of the Declaration of Helsinki and the Ethical Guidelines for Korean Good Clinical Practice. All the participants will be provided written informed consent and be informed that they can voluntarily withdraw their consent at any stage. Participants will receive comprehensive details regarding the study protocol, purpose, eligibility criteria, random allocation, schedule, benefits and risks, alternative treatment options, and confidentiality of trial information. All source data collected though this study will be kept confidential and will be statistically analyzed by a third party.

While our research team has previously conducted clinical trials exploring the effectiveness of acupotomy for spinal disorders [14] and pharmacopuncture therapy for LSS [13], we have not encountered any prior clinical trials investigating the combined effect of these two therapies in treating LSS. As such, this study aims to fill this gap in the previous studies and provide valuable insights into the potential synergistic benefits of combining these interventions for patients with LSS.

Based on previous studies regarding acupotomy [14] and pharmacopuncture therapy [13], this pragmatic, randomized, controlled study was designed to evaluate the overall effectiveness of combined interventions for patients with LSS in a clinical healthcare setting. The eligibility criteria were strictly designed to diagnose degenerative lumbar spinal stenosis. Researchers will evaluate MRI/CT images and clinical symptoms, including pain, neurological discomfort, and gait disturbances, to diagnose patients with LSS. Patients with a history of spinal surgery who do not respond well to conservative treatment will be excluded.

Acupotomy uses a flat blade at the end of a needle to peel off adhesions from the soft tissue. It should only be performed by an experienced medical professional because it risks damaging the normal tissue. Therefore, we will use ultrasound guidance with experienced practitioners to conduct the intervention safely. CKMT, which includes acupuncture, electroacupuncture, cupping, and infrared irradiation, is widely used in complementary medical settings. This study’s designs will help secure external validity by reflecting realistic and practical aspects.

In this study, we adopted multiple evaluation indicators, including the VAS, MCID, RMDQ, self-reported maximum walking distance, EQ-5D5L, PGIC, and ZCQ. We aimed to assess not only changes in pain but also changes in functional disability caused by LSS. The RMDQ is suitable for assessing the level of pain-related functional disability caused by lumbar pain. Additionally, the ZCQ and self-reported maximum walking distance can be used to detect the impact of gait disturbances on dysfunction.

However, this study has some limitations. First, since neither the participants nor practitioners can be blinded to the intervention, the results of this study may be biased in favor of the experimental group. To minimize bias by the practitioners, we will separate “pharmacopuncture therapy with acupotomy” and “CKMT” practitioners and ensure that the practitioners in charge of CKMT provided to both groups remains blind to the group assignment. Additionally, to ensure the objectivity and reliability of the research results, we will have an independent assessor who will be blinded to the group allocation. Secondly, there is a lack of evidence regarding optimizing Ultrasound-guided interventions. To address this, we have developed a protocol based on the clinical experience of our research team and existing papers [25-27]. Thirdly, the sample will be recruited from a single center, and the 8-week follow-up period after treatment will be relatively short. Additionally, it will only be able to evaluate the combined effect of pharmacopuncture and acupotomy, and not the individual effects of each treatment. This is because the study is designed to be pragmatic and reflect the way that these therapies would be used in a real-world clinical setting.

The results of this study will contribute to the treatment goals for patients with LSS, including decreasing pain intensity, alleviating claudication, increasing functional mobility, and reducing the need for surgery. Furthermore, the details of the treatment protocols for acupotomy derived from this study will be used as valuable insights and data for designing future ultrasound-guided studies.

This study was supported by grants from the project of the Korea Institute of Oriental Medicine (KSN1823211).

Conceptualization: Chang-Hyun Han, Changsop Yang, Eunseok Kim; Data curation: Byoung-Kab Kang; Formal analysis: Byoung-Kab Kang; Investigation: Jihun Kim, Yeonhak Kim, Taewook Lee; Methodology: Jihun Kim, Chang-Hyun Han, Eunseok Kim; Project Administration: Eunseok Kim; Resources: Kun Hyung Kim, Gi Young Yang, Eunseok Kim; Supervision: Eunseok Kim, Young Eun Choi, Changsop Yang; Validation: Young Eun Choi, Eunseok Kim, Kun Hyung Kim, Gi Young Yang; Visualization: Yeonhak Kim; Writing-original draft: Jihun Kim, Chang-Hyun Han; Writing-review and editing: Eunseok Kim.

The authors declare no conflict of interest.