This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.
Full Title of Study: “Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: December 2017
Background: Sciatica is primarily caused by herniated discs with nerve-root compression. Acupuncture may effectively relieve the pain of discogenic sciatica, but the evidence is limited.
Methods/Design: Sixty patients with discogenic sciatica will be recruited and randomized to receive acupuncture or sham-acupuncture at a 1:1 ratio. Patients in both groups will receive treatment 3 times per week for 4 weeks. The following acupoints will be used: Dachang shu (BL 25), Shenshu (BL 23), Weizhong (BL 40), and Chengshan (BL 57).
- Procedure: Acupuncture
- Shenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied. A Huatuo Brand needle (0.3*75 mm) for BL25 will be inserted at a depth of 40-70 mm vertically until the patient feels soreness and a distension sensation that radiates to the leg. The needle will be lifted 1-2 mm without rotating or lifting. Huatuo Brand needles (0.3*40 mm) at the other acupoints (BL23, BL40 and BL57) will be inserted 30 mm and manipulated by lifting, thrusting, twirling evenly until the Deqi sensation is achieved. The needles in these acupoints will be manipulated by small evenly applied lifting, thrusting, and twirling movements 3 times every 10 minutes.
- Procedure: Sham acupuncture
- Specially designed sham needles (0.3*25 mm) will be used. The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group). The acupoints will be the same as the acupuncture group. The needle will be inserted vertically until pressed against the skin without penetration. The manipulation will be consistent with the acupuncture group and blind to the patients.
Arms, Groups and Cohorts
- Experimental: Acupuncture
- Shenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied. Huatuo Brand needle (0.3*75 mm) will be used for BL25 and Huatuo Brand needle (0.3*40mm) will be used for BL23, BL40 and BL57.
- Sham Comparator: Sham acupuncture
- The acupoints will be the same as the acupuncture group. Specially designed sham needles (0.3*25 mm) will be used . The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group).
Clinical Trial Outcome Measures
- change from baseline in mean weekly VAS of leg pain
- Time Frame: Baseline, weeks 1-4, week 16 and week 28
- VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of leg pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of leg pain over weeks 1-4 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
- Change in mean weekly VAS of low back pain
- Time Frame: Baseline, weeks 1-4, week 16 and week 28
- Patients will rate their average low back pain intensity in the past 24 hours using VAS. The mean weekly VAS of low back pain over weeks 1-4 will be calculated as described above for the mean weekly VAS of leg pain over weeks 1-4.
- Oswestry disability index
- Time Frame: Baseline, week 4, week 16 and week 28
- ODI consists of 10 questions, including pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question is scored on a scale of 0-5. The scores for all questions answered are summed and divided by the highest possible score to obtain the index (range 0% to 100%). 0% equals no disability, and 100% is the maximum disability possible
- Patients’ global impressions of improvement
- Time Frame: week 4
- Patients’ global impressions of improvement measured using a Likert 7-point scale (higher scores indicate worse outcome).
- Patients’ expectations for acupuncture
- Time Frame: baseline
- This questionnaire includes three brief questions to investigate whether patients believe that acupuncture treatment will help their sciatica. The relationship between patients’ expectations and the effectiveness of acupuncture will be investigated because patients’ beliefs about treatment enhanced or attenuated the effectiveness of treatment in a previous experimental study .
- Blinded evaluation
- Time Frame: week 4
- Blinded evaluation as measured by patient questioning of whether they believed they received real acupuncture at week 4. The difference in the proportion of patients who believed that they received real acupuncture between the two groups will be analyzed.
- Incidence of serious adverse events
- Time Frame: up to 28 weeks
- The investigators will record and evaluate all adverse events .
Participating in This Clinical Trial
1. Unilateral leg pain diagnosed as discogenic sciatica;
2. Sciatica patients with an average leg pain VAS of 40 mm or higher in the last 24 hours;
3. Aged 18 to 75 years;
4. Leg pains that correlate with CT or MRI findings of lumbar disc herniation;
5. Patients who agree to follow the trial protocol.
1. Severe cases with central or giant or ruptured lumbar disc herniation, cauda equina syndrome, foot drop, or surgery requirements;
2. Progressive neurological symptoms after 3 months of strict conservative treatment (e.g., nerve root adhesion, crossed straight-leg testing, or obvious muscle atrophy);
3. Severe cardiovascular, liver, kidney, hematopoietic system diseases, autoimmune diseases, or poor nutritional status;
4. Subjects with cognitive impairment;
6. Subjects who received acupuncture for sciatica within the past month.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Guang’anmen Hospital of China Academy of Chinese Medical Sciences
- Provider of Information About this Clinical Study
- Principal Investigator: Qin Yao, Postgraduate – Guang’anmen Hospital of China Academy of Chinese Medical Sciences
- Overall Official(s)
- Qin Yao, Principal Investigator, Department of Acupuncture, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China
- Overall Contact(s)
- Qin Yao, +86-15650728152, firstname.lastname@example.org
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