Efficacy and Safety of Warm Acupuncture Compared to Gabapentin for Pain Management in Patients with Sciatica in Bhutan: A Randomized Controlled (ACUWARM) Trial

Abstract

Introduction

Sciatica is a significant health issue, primarily affecting the young population, and causes considerable distress. Acupuncture has been investigated as a potential treatment to address the gap in effective management options for sciatica. This study aimed to compare pain severity, disability, and quality of life, and adverse events in subjects with sciatica receiving warm acupuncture compared those receiving oral gabapentin.

Methods

This randomized controlled non-inferiority clinical trial involved the use of the minimization technique for randomization. Seventy participants were enrolled and divided into two groups: Warm Acupuncture Group and Gabapentin Group.

Results

On Day 15, the Visual Analogue Scale (VAS) score was significantly lower in the acupuncture group compared to the gabapentin group (4.3 vs 5.2, P = .029). On Day 30, the VAS score further decreased in the acupuncture group (1.4 vs 3.6, P < .001). Warm acupuncture demonstrated non-inferiority in reducing low back pain at Day 30 and showed significant improvement in gluteal, thigh, and leg pain scores on Days 15 and 30. Improvements in disability scores were significantly higher in the acupuncture group on Days 15 (73.7% vs 22.3%) and Day 30 (92.3% vs 44.6%). No adverse events related to warm acupuncture were reported.

Conclusion

The standardized protocol of warm acupuncture was non-inferior to gabapentin in reducing pain severity by Days 15 and 30. Warm acupuncture resulted in higher improvements in disability scores with no reported adverse events. Thus, warm acupuncture presents a viable alternative to gabapentin for managing pain in patients with sciatica.

Keywords

alternative medicine non-pharmacological therapy pain quality of life traditional medicine

Introduction

Sciatica is a significant health issue affecting various countries. In a survey conducted in the United States among 1,000,952 patients, the prevalence of sciatica was found to be 25%.¹ It predominantly affects the young working population.^1,2 Sciatica is characterized by radiating leg pain along the course of the sciatic nerve, often accompanied by back pain and neurological deficits.³ The most common cause of sciatica is disc herniation of the fourth or fifth lumbar intervertebral discs, resulting in pain along the sciatic nerve distribution.⁴ Risk factors for sciatica include age, body mass index, mental stress, heavy lifting, trauma, and cigarette smoking.^4–7

Conservative management for sciatica includes exercise and manual therapy, medications such as paracetamol, benzodiazepines, opioids, short-term corticosteroids, and spinal injections.³ Neuromodulators like pregabalin and gabapentin have also been suggested. A randomized, double-blind, double-dummy crossover trail comparing pregabalin and gabapentin in the management of chronic sciatica showed that gabapentin was superior to pregabalin, with fewer and less severe adverse events.³ Both medications displayed significant reductions in visual analogue pain intensity scale and Oswestry Disability Index (ODI).³

Over the past decade, evidence regarding the use of gabapentin and pregabalin for sciatica treatment has been conflicting. A systematic review in 2022 involving eight randomized controlled trials and 747 participants demonstrated a statistically significant improvement in leg pain at 2 weeks and leg pain with movement at 3 and 4 months with gabapentin compared to placebo.⁸

Non-pharmacological therapies, including exercise, spinal mobilization, massage, tai chi, yoga, and acupuncture play an important role in the treatment of sciatica.⁹ Acupuncture, in particular, has shown benefits in treating sciatica. Systematic reviews have reported its effectiveness for sciatica management.^10,11 Additionally, randomized controlled trials revealed that acupuncture had short-term clinical benefits for chronic discogenic sciatica compared with sham acupuncture and had greater short-term and long-term benefits in comparison to medium-frequency electrotherapy.¹²

According to Traditional Chinese Medicine, sciatica belongs to the gallbladder meridian of the foot-Shaoyang and the bladder meridian of the foot-Taiyang. It is considered a channel disorder where acupuncture is used to remove channel obstructions and promote qi and blood circulation. Key acupoints for treating sciatica include Yanglingquan (GB 34) and Hauntiao (GB 30).^11,13 Other acupoints used in treating sciatica pain are Shenshu (BL 23), Dachangshu (BL 25), Zhibian (BL 54), Hauntiao (GB 30), Weizhong (BL 40), Yanglingquan (GB 34), Chengshan (BL 57), Kunlun (BL 60), and Xuanzhong (GB 39).¹⁴ These acupuncture points can be stimulated for about 30 min through surface pressure, needle insertion with or without manipulation, heating of acupuncture needles through radiant heat or moxibustion, and electrical or laser stimulation.

In Bhutan, Traditional Medicine services are based on ancient texts and oral transmission from learned masters, recognized as mainstream medicine by the Royal Government of Bhutan in 1968.¹⁵ Acupuncture services were introduced in 2018 and are delivered by selected trained Traditional Medicine practitioners. While acupuncture is gaining popularity in Bhutan, it is not yet a mainstream therapy due to the lack of sufficient experts and resources. Clinical experience indicates that warm acupuncture is effective in treating sciatica, but strong clinical evidence is lacking. This study evaluated the safety and effectiveness of acupuncture for sciatica through a randomized controlled clinical study among adult patients with sciatica visiting the Jigme Dorji Wangchuck (JDW) National Referral Hospital and the National Traditional Medicine Hospital in Bhutan in 2022.

Methods

Study Design

This was a non-inferiority randomized controlled open-label trial. Blinding was not possible as ‘sham’ warm acupuncture and placebo were practically difficult to implement. Therefore, this study was conducted as an open-label trail.

Study Site

The study sites included the Orthopaedic Surgery Out-Patient Department (OPD) at the JDW National Referral Hospital, Thimphu where the investigators and orthopaedic surgeons recruited patients. Those randomized to intervention arm received warm acupuncture at the National Traditional Medicine Hospital, Thimphu.

Bhutan has a three-tiered healthcare system comprising 179 Primary Health Centres, 53 sub-posts and 555 outreach clinics at the primary level; 49 district and general hospitals at the secondary level; and three referral hospitals at the tertiary level. The JDW National Referral Hospital is the largest allopathic hospital in the country with specialist services available.

The Traditional Medicine Units are co-located with hospitals in other districts except the capital Thimphu where the National Traditional Medicine Hospital is located separate because of its sheer size, inpatient services and its function as a teaching hospital for training Traditional Medicine physicians. These two hospitals are located at a distance of 3 km from each other.

Study Population

Patients clinically diagnosed with sciatica were recruited for the study. Sciatica was defined in patients fulfilling the following diagnostic criteria¹³: Unilateral radiating leg pain below the knee with positive straight-leg raise test or at least one neurological deficit, or Leg pain intensity measured by the visual analogue scale.

The following were the inclusion criteria: Patients aged 20 to 70 years and symptom duration of 1 month or longer. The following were the exclusion criteria: Patients suspected to have severe spinal diseases such as cauda equina syndrome; Patients who have undergone surgery for lumbar disc herniation within the past 6 months; Patients on antiepileptic medication, antidepressant medication, opioids or corticosteroids; Patients with cardiovascular, liver, kidney, or hematopoietic system diseases, mental health disorders, or other severe coexisting diseases (eg, cancer); Patients who are pregnant, breastfeeding, or planning to conceive; Patients who received acupuncture therapy within the past 6 months; Physical disabilities – loss of limb or paraplegia; History of metal allergies; Infection at the site of needle insertion; and Patients already on gabapentin.

A total of 70 participants were enrolled based on the inclusion and exclusion criteria. Screening for eligible participants was done on Day 0 according to the inclusion criteria. The actual study period for each participant was three weeks, excluding screening and follow-up.

Sample Size

The sample size for the non-inferiority trail was calculated using the following formula.

n = 2 \times f (α, β) \times \frac{π \times (100 - π)}{δ^{2}} in each group

where: f(α,β) = (z_1−α/2 + z_1−β)² = 7.85 for 80% power, π = assumed percentage response in both groups is equivalent at (98%),

δ

= Equivalence margin or delta (10%).

Based on the above considerations, with a 10% loss to follow-up or poor data, the sample size required was 35 in each group.

Randomization

To avoid selection (randomization) bias, after the diagnosis of sciatica was made, an independent biostatistician telephonically randomized the patients into two arms using the minimization method. For the first patient and when totals were equal, simple randomization was used based on age, sex, and baseline pain score on the visual analogue scale.

Study Tools

The study tool consisted of a case record form that collected basic contact information, sociodemographic data, medical history, and clinical examination findings. The severity of pain was assessed using a four-point Likert scale and the visual analogue scale. The Roland-Morris Low Back Pain and Disability Questionnaire was used to assess the disability domains. Quality of life was assessed using the Health Survey Questionnaire (SF-36).

Participant Recruitment

The recruitment process was structured as follows:

Initial Screening: Patients visiting the Orthopaedic Surgery OPD at JDW National Referral Hospital for sciatica symptoms were preliminarily screened based on the inclusion and exclusion criteria.

Detailed Evaluation: Those meeting the initial criteria underwent a thorough evaluation, including a detailed medical history and clinical examination, to confirm eligibility.

Informed Consent: Eligible patients were provided with detailed information about the study, including its purpose, procedures, potential risks, and benefits. Written informed consent was obtained from each participant before enrolment.

Enrolment and Randomization: Enrolled participants were then randomized into either the warm acupuncture treatment group or the gabapentin group, as per the randomization protocol described in the methods section.

Intervention and Follow-up: Post-randomization, participants followed a specific protocol for their assigned treatment. The process included regular monitoring, follow-up assessments, and data collection as per the study design.

Study Intervention

Patients allocated to the warm acupuncture intervention were advised to have a routine breakfast and report to the National Traditional Medicine Hospital. They were advised to avoid alcohol, strenuous physical activities, and coffee at least two hours prior to the treatment.

In preparation for warm acupuncture, patients were kept in complete bed rest in a prone position for 5-10 min in a cool and calm environment. During this period, participants were advised not to talk, eat, drink, or engage in physical or mental activity.

The warm acupuncture sessions were provided by trained and certified Traditional Medicine Practitioners at the National Traditional Medicine Hospital. Each session of warm acupuncture lasted for 20-70 min. Each trial subject received three sessions per week for a duration of three weeks.

The warm acupuncture sessions targeted the following anatomical points¹⁴: Gallbladder meridian of the foot-Shaoyang, bladder meridian of the foot-Taiyang, and the Yanglingquan (GB 34) and Huantiao (GB 30) are two key acupoints; and Shenshu (BL 23), Dachangshu (BL 25), Zhibian (BL 54), Huantiao (GB 30), Weizhong (BL 40, Yanglingquan (GB 34), Chengshan (BL 57), Kunlun (BL 60), Xuanzhong (GB 39) and Ashi points.

Active Control

For the participants under the control arm, Oral Gabapentin 300 mg twice daily was prescribed by the orthopaedic surgeon at the Orthopaedic Surgery OPD, JDW National Referral Hospital.

Discontinuation and Withdrawal Criteria

During the trial, the following withdrawal and discontinuation criteria were used: Subjects unable to tolerate either gabapentin or acupuncture; Missing any of the prescribed acupuncture sessions; Allergy or severe reaction to intervention or gabapentin; Patients started any other treatment regime during the study period; and Worsening of symptoms.

Study Variables/Outcomes

The following variables were collected: age, sex, socio-demographic profile of the patient, history of smoking, alcohol, trauma, neuromuscular disorders, diabetes, hypertension, chronic kidney disease, cancer, bleeding disorders, use of anticoagulants. Examination findings included the assessment of body posture, tenderness over muscles and joints and straight-leg raise test (positive/negative).

Pain severity was assessed in four body regions (lower back, gluteal region, back of thigh and in the legs) on a Likert score ranging from 0 to 3 and on visual analogue scale score ranging from 0 to 10 on days 0, 15 and 30.

Disability resulting from low back pain was assessed using the Roland-Morris low backpain and disability questionnaire that contains 24 items. The total score on this scale was a cumulative sum of the total number of marked statements. Clinical improvement over time was graded based on the analysis of serial questionnaire scores.

Quality of life was assessed using the SF-36 Health Survey Questionnaire, covering general health, physical activities, physical health problems, emotional health problems, social activities, pain severity, energy, and emotions.

Data on side effects from warm acupuncture such as reduced consciousness, mood changes, leg swelling, allergy, infection risk, and dizziness were collected.

An independent assessor, trained to evaluate the outcome variable, conducted assessments to remove bias from the implementer and assessor being the same person.

Statistical Analysis

The data were double entered and validated using Epi Data Entry 3.1 (EpiData Association, Odense, Denmark). Subsequently, the data were exported to and analyzed in STATA 18 (StataCorp LP, USA). Continuous variables are presented as means and standard deviations or medians and interquartile ranges. Categorical variables are presented as frequencies and percentages. Comparison between groups were done using chi-squared test or Fisher's exact test for categorical variables, and unpaired t-tests or Wilcoxon rank sum tests for continuous variables, as appropriate. The intention-to-treat principle was employed for the data analysis to compare the outcomes. The primary outcome was described between the warm acupuncture and gabapentin groups (Point Estimate and 95% CI), with a non-inferiority margin of 10%. All reported adverse events are described for each arm. P values less than .05 were considered significant.

Ethics Approval

This study was conducted in accordance with the principles of the Declaration of Helsinki. Ethics approval for the study was obtained from the Institutional Review Board of Tianjin University of Traditional Chinese Medicine, Tianjin, China, and the Research Ethics Board of Health, Ministry of Health, Bhutan (REBH/Approval/2022/001 dated 07 February 2022). Additionally, administrative clearance was obtained from the Ministry of Health, Royal Government of Bhutan. This clinical trial was registered at the Thai Clinical Trials Registry (TCTR20220211005).

Results

Seventy patients were randomized to the intervention and control arms and followed up for 30 days. The CONSORT diagram for this study is shown in Figure 1.

Figure 1.

CONSORT Chart on the Number of Patients Randomized and Followed up in the Clinical Trial to Assess Warm Acupuncture Versus Gabapentin in the Treatment of Sciatica, Bhutan 2022.

The mean age of the sample was 41.4 (±12.8) years and there were 39 females (55.7%). The mean age was 41.7 (±12.7) years in the warm acupuncture group and 41.1 (±13.1) in the gabapentin group. The comparison of the basic socio-demographic and clinical profile of the patients is shown in Table 1.

Table 1.

Sociodemographic and Clinical Profile of the Subjects who Participated in the Clinical Trial on the Assessment of Warm Acupuncture Versus Gabapentin in the Treatment of Sciatica in Thimphu, Bhutan, 2022.

Patient characteristics	Warm acupuncture		Gabapentin		P value*
Patient characteristics	n	(%)	n	(%)	P value*
Age (years)
21-24	4	(50.0)	4	(50.0)	.585
25-34	7	(46.7)	8	(53.3)
35-44	11	(61.1)	7	(38.9)
45-54	6	(35.3)	11	(64.7)
55-64	6	(66.7)	3	(33.3)
≥65	1	(33.3)	2	(66.7)
Sex
Male	16	(51.6)	15	(48.4)	.810
Female	19	(48.7)	20	(51.3)	.810
Marital status
Married	27	(49.1)	28	(50.9)	.771
Never married	8	(53.3)	7	(46.7)	.771
Level of education
No schooling	13	(46.4)	15	(53.6)	.488
Non-Formal Education or primary education	2	(25.0)	6	(75.0)
Secondary education	11	(57.9)	8	(42.1)
Certificate / diploma	2	(50.0)	2	(50.0)
Bachelor's degree and above	7	(63.6)	4	(36.4)
Household income (Nu/month)
Nu 0-10 000	10	(47.6)	11	(52.4)	.199
Nu >10 000-30 000	18	(45.0)	22	(55)
Nu >30 000-50 000	3	(60.0)	2	(40.0)
Nu >50 000	4	(100.0)	0	(0.0)
Medical history
Smoking	8	(40.0)	12	(60.0)	.290
Alcohol consumption	10	(52.6)	9	(47.4)	.788
History of trauma, fall or injury	0	-	1	(100.0)	.314
Arthritis	0	-	2	(100.0)	.151
Diabetes mellitus or hypertension	4	(33.3)	8	(66.7)	.205
Bleeding disorders	1	(50.0)	1	(50.0)	1.000
Clinical evaluation
Reduced mobility at lumbar spine	6	(75.0)	2	(25.0)	.133

1 US dollar = 75 ngultrums (Nu) in 2022.

*P value by unpaired t-test.

Primary Outcome: Pain Scores Related to Sciatica

The pain scores across four body regions (low back, gluteal, back of the thigh and leg) are shown in Table 2. Both groups demonstrated a decrease in pain scores over the observation period, with the acupuncture group achieving significantly lower pain scores in specific regions by Day 30.

- Low Back Pain: The acupuncture group had significantly lower low back pain scores on Day 30 compared to the gabapentin group (0.6 vs 1.2, P = .001, Figure 2a).

- Gluteal Region Pain: On Day 30, the acupuncture group reported significantly lower pain scores in the gluteal region (0.1 vs 0.8, P < .001, Figure 2b).

- Back of the Thigh Pain: Similarly, the acupuncture group had significantly lower pain scores at the back of the thigh on Day 30 (0.1 vs 0.6, P = .003, Figure 2c).

- Leg Pain: However, the decrease in leg pain scores was not sustained in the acupuncture group at Day 30 (1.9 vs 1.6, P = .010, Figure 2d).

Figure 2.

(a) Subjects Who Received Warm Acupuncture had Significant Reduction in the Low Back Pain Score on Day 30 Compared to Subjects Who Received Gabapentin. (b) Subjects Who Received Warm Acupuncture had Higher Gluteal Pain Scores at Baseline and had Significant Reduction of Gluteal Pain Scores on Days 15 and 30. (c) Subjects Who Received Warm Acupuncture Had Higher Pain Score at the Back of the Thigh but had Significantly Lower Pain Scores on Days 15 and Day 30. (d) Subjects Who Received Warm Acupuncture had Higher Baseline Leg Pain Scores and Showed a Decrease on Day 15, but had Worse Leg Pain Scores on Day 30.

Table 2.

The Pain Score on the Visual Analogue Scale and Roland-Morris Disability Score among Patients who Were Treated with Warm Acupuncture Versus Gabapentin for Sciatica in Thimphu, Bhutan, 2022.

Patient characteristics	Warm acupuncture		Gabapentin		P value*
Patient characteristics	Mean	(±SD)	Mean	(±SD)	P value*
Pain score on visual analogue scale
Day 0	8.3	(±1.3)	6.5	(±1.2)	<.001
Day 15	4.3	(±1.5)	5.2	(±1.9)	.029
Day 30	1.4	(±1.0)	3.6	(±2.4)	<.001
Roland-Morris disability score
Day 0	18.8	(±5.1)	11.7	(±5.0)	<.001
Day 15	4.9	(±3.8)	9.1	(±5.1)	<.001
Day 30	1.4	(±1.2)	6.5	(±5.6)	<.001
Adverse events
Light headedness	0	(0.0)	2	(5.7)	–
Drowsiness	0	(0.0)	2	(5.7)	–

SD = standard deviation.

*P value by unpaired t-test.

Overall, warm acupuncture demonstrated significant improvements in reducing pain scores in the low back, gluteal region, and back of the thigh, although the effect on leg pain was less sustained.

The point estimate difference of scores for low back pain, gluteal pain, pain at the back of the thigh, and leg pain favours warm acupuncture, as shown in Figure 3. For all these body regions, the point estimates are well below the non-inferiority margin, suggesting superiority of warm acupuncture over gabapentin.

Figure 3.

Warm Acupuncture Versus Gabapentin in the Assessment of Pain Scores in Patients with Sciatica in Bhutan, 2022. r1 = Mean “low Back Pain Score” on Day 15; r2 = Mean “low Back Pain Score” on Day 30; r3 = Mean “Gluteal Pain Score” on Day 15; R4 = Mean “Gluteal Pain Score” on Day 30; r5 = Mean “Back of the Thigh Pain Score” on Day 15; r6 = Mean “Back of the Thigh Pain Score” on Day 30; r7 = Mean “leg Pain Score” on Day 15; r8 = Mean “leg Pain Score” on Day 30.

On the visual analogue scale, patients allocated to the acupuncture group had a higher mean score at baseline compared to those allocated to the gabapentin group (8.3 vs 6.5, P < .001). However, the acupuncture group showed significantly lower pain scores on Day 15 (4.3 vs 5.2, P = .029) and Day 30 (1.4 vs 3.6, P < .001). The details of the overall pain score on the visual analogue scale are shown in Table 2.

Secondary Outcomes: Disability Related to Sciatica

Subjects allocated to warm acupuncture had higher low back pain disability scores at baseline (18.8 vs 11.7, P < .001). The disability scores were significantly lower among those who received warm acupuncture when assessed at Day 15 (4.9 vs 9.1, P < .001) and at Day 30 (1.4 vs 6.5, P < .001), as shown in Table 2.

Secondary Outcomes: Quality of Life (SF-36)

On Day 15, those allocated to the acupuncture group had higher quality of life scores in the following domains: Physical Functioning (72.5 vs 50, P = .003), Role Limitations Due to Physical Health (100 vs 75, P = .001), Role Limitations Due to Emotional Problems (100 vs 33.3, P < .001), Levels of Energy (80 vs 45, P < .001), Emotional Well-being (80 vs 56, P < .001), Social Functioning (50 vs 37.5, P = .002) and General Health (60 vs 45, P < .001, Table 3).

Table 3.

Quality of Life Based on the SF-36 Domains among Patients who Were Treated with Warm Acupuncture Versus Gabapentin for Sciatica in Bhutan, 2022.

Patient characteristics	Warm acupuncture		Gabapentin		P value*
Patient characteristics	Median	(IQR)	Median	(IQR)	P value*
Day 0
Physical functioning	0	(0, 30)	50	(15, 50)	<.001
Role limitations due to physical health	0	(0, 10)	0	(0, 70)	.001
Role limitations due to emotional problems	0	(0, 12.5)	12.5	(0, 75)	<.001
Level of energy/fatigue	28	(24, 52)	42	(30, 46)	.263
Emotional well-being	39.1	(33.3, 52.5)	51.7	940, 61.7)	.018
Social functioning	50	(25, 50)	37.5	(25, 37.5)	.027
Pain	65	(52.5, 77.5)	45	(42.5, 55)	<.001
General health	40	(30, 45)	45	(40, 45)	.079
Day 15
Physical functioning	72.5	(50, 87.5)	50	(25, 65)	.003
Role limitations due to physical health	100	(75, 100)	75	(0, 100)	.001
Role limitations due to emotional problems	100	(100, 100)	33.3	(0, 100)	<.001
Level of energy/fatigue	80	(77.5, 85)	45	(35, 70)	<.001
Emotional well-being	80	(80, 88)	56	(52, 72)	<.001
Social functioning	50	(37.5, 50)	37.5	(25, 50)	.002
Pain	42.5	(42.5, 52.5)	45	(42.5, 52.5)	.730
General health	60	(50, 65)	45	(40, 50)	<.001
Day 30
Physical functioning	100	(77.5, 100)	65	(50, 80)	<.001
Role limitations due to physical health	100	(100, 100)	87.5	(50, 100)	<.001
Role limitations due to emotional problems	100	(100, 100)	66.7	(33.3, 100)	<.001
Level of energy/fatigue	90	(80, 95)	65	(50, 80)	<.001
Emotional well-being	92	(84, 100)	64	(56, 82)	<.001
Social functioning	50	(50, 62.5)	37.5	(37.5, 50)	.001
Pain	50	(40, 52.5)	45	(42.5, 52.5)	.655
General health	60	(55, 65)	45	(45, 52.5)	<.001

*P value by Wilcoxon rank sum test.

On Day 30, those allocated to the acupuncture group had higher quality of life scores in the following domains: Physical Functioning (100 vs 65, P < .001), Role Limitations Due to Physical Health (100 vs 87.5, P < .001), Role Limitations Due to Emotional Problems (100 vs 66.7, P < .001), Levels of Energy (90 vs 65, P < .001), Emotional Well-being (92 vs 64, P < .001), Social Functioning (50 vs 37.5, P < .001) and General Health (60 vs 45, P < .001, Table 3).

Adverse Effects Observed

There were no patients who reported adverse events related to acupuncture during the trial period. In the gabapentin group, two patients reported light-headedness and drowsiness (Table 2). There were no drop outs related to adverse effects (the drop outs were patients unable to present to the hospital for evaluation).

Discussion

In the follow up periods at Days 15 and 30, there were significant decreases in the intervention group in low back pain, gluteal pain, and thigh pain scores. There was also a significant decrease in the overall pain score on the visual analogue scale in the intervention group. The standardized protocol of warm acupuncture is not inferior to gabapentin in achieving lower pain scores in the low back, gluteal and thigh regions.

Warm acupuncture has been shown to decrease chronic non-specific low back pain in many settings and conditions. Among patients with lumbar disc herniation in Inner Mongolia, China, patients treated with warm acupuncture had significant reduction in the pain score (waist pain and leg pain) with a therapy duration of two weeks compared to non-steroidal anti-steroidal agent, ibuprofen.¹⁶ In this study, acupuncture therapy was given using silver needles warmed up to 40°C. In another study involving 449 patients in Brazil, acupuncture significantly reduced VAS scores in conditions such as low back pain, fibromyalgia, dysesthesia, neck pain, myofascial pain, shoulder pain, and headache, with mean VAS scores decreased from 7.3 at the beginning to 3.2 at the end of the session,¹⁷ compared to a decrease from 8.3 to 1.4 noted in our study.

However, a Cochrane review in 2020, which included 33 studies with 8270 participants from Europe, Asia, North and South America, reported low-certainty evidence that acupuncture may relieve immediate-term low back pain compared to sham interventions, with a mean difference of −9.22 points on the VAS scale (range 0-100).¹⁸ This difference did not meet the clinically important threshold of 15 points or 30% relative change. Subgroup analysis showed that acupuncture reduced pain with a mean difference of −10.26%, not meeting the clinically important difference threshold, but it improved back-specific functions.

Is acupuncture really ineffective for chronic low back pain? Traditional Chinese Medicine posits that low back pain results from the blockage of the body's vital energy, known as qi, which flows along the 12 primary and 8 sary meridians.¹⁹ The insertion of acupuncture needles at specific points along the meridians restores the proper flow of qi. For the treatment of low back pain and sciatica, the acupuncture points targeted are Shenshu, Dachangshu, Huantiao, Weizhong, and Kunlun. To study the efficacy of this ancient method of acupuncture through the lens of modern medicine and to understand its effects through physiological and measurable parameters, a combined understanding of Traditional Chinese Medicine and physiology is required. It has been demonstrated that acupuncture induces the release of endogenous opioids in the brain stem, subcortical, and limbic structures, modulating pain perception. Functional magnetic resonance imaging has shown prolonged stimulations in the limbic systems and basal forebrain. Positron emission tomography has shown an increase in μ-opioid binding potential in several brain areas.¹⁹ In mouse models, acupuncture has been demonstrated to promote neural proliferation in the hippocampus through the Wnt/β-catenin signaling pathway.²⁰

Given various physiological bases and mechanisms for pain modulation, it is likely that acupuncture produces real therapeutic effect. This brings into question the methodology and implementation of randomized controlled trials in assessing the efficacy of acupuncture, the standardization of acupuncture therapy, and the standardization of sham acupuncture or construction of a comparable control arm.²¹ In this study, acupuncture was delivered strictly based on the protocol adopted by the National Traditional Medicine Hospital, Bhutan.

Patients in the intervention group had significantly higher scores in selected domains of quality of life (physical functioning, level of energy, emotional well-being, social functioning, and general health) at Days 15 and 30. These effects can be understood in the context of the neuro-modulatory effects of acupuncture therapy.¹⁹ Similar improvements have been demonstrated with high-dose manual acupuncture administered twice weekly for four weeks.²²

In this study, there were no patients who reported adverse events related to warm acupuncture. Major adverse events related to acupuncture are reported to be rare, with significant adverse events occurring in less than 0.1% of cases.¹⁹ The adverse events may include needle-site pain, nausea, vomiting, light headedness, or fainting. However, given that acupuncture services are only at the initial stages of being adopted and implemented in Bhutan, it remains important to be vigilant in observing and reporting of adverse events related to this procedure.

Limitations

This was a single-centre study with therapy provided within the unique system of Bhutanese Traditional Medicine through a government-sponsored healthcare service delivery in Bhutan. There were no adverse events observed in the group receiving the standardized protocol of warm acupuncture. This might have been due to the small sample size. In this study, randomization was performed at the time of diagnosis and baseline score on pain and disability were collected thereafter. The baseline pain score on Visual Analogue Scale and Roland-Morris disability score were higher in the warm acupuncture group.

Conclusions

In patients with sciatica, the use of a standardized protocol of warm acupuncture therapy was non-inferior to gabapentin in achieving lower pain scores and significant improvements in disability score and quality of life score. There were no adverse events reported related to warm acupuncture.

Footnotes

Acknowledgements

We thank the Jigme Dorji Wangchuck National Referral Hospital, National Traditional Medicine Hospital and Ministry of Health, Royal Government of Bhutan for their support in the conduct of this study. We thank the professors at the Tianjin University of Traditional Chinese Medicine, Tiajin, China for their guidance and support for this study.

Authors’ Contributions

All authors were involved in Conceptualization, Methodology, Writing – original draft and Writing – review and editing. DG and TD were involved in Resources and Data Curation. DG, TD, MSG and TC were involved in Software, Validation and Formal analysis.

Availability of Data and Materials

The complete dataset is available from the corresponding author on request, and after approval from the Ministry of Health, Royal Government of Bhutan.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethics Approval and Consent to Participate

This study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval for the study was obtained from the Institutional Review Board of Tianjin University of Traditional Chinese Medicine, Tianjin, China, and the Research Ethics Board of Health, Ministry of Health, Bhutan (REBH/Approval/2022/001 dated 07 February 2022). Additionally, administrative clearance was obtained from the Ministry of Health, Royal Government of Bhutan. Informed written consent was obtained from each participant. Clinical trial registry: Thai Clinical Trials Registry (TCTR20220211005 dated 11 Feb 2022). Link here.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Dorji Gyeltshen

Thinley Dorji

Karma Tenzin

Mongal Singh Gurung

Krit Pongpirul

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