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Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial (NCT02770963)

This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.
  • 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.
      Ages eligible for Study
      18 Years to 75 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Unilateral leg pain diagnosed as discogenic sciatica;
      • Sciatica patients with an average leg pain VAS of 40 mm or higher in the last 24 hours;
      • Aged 18 to 75 years;
      • Leg pains that correlate with CT or MRI findings of lumbar disc herniation;
      • Patients who agree to follow the trial protocol.
      Exclusion Criteria:
      • Severe cases with central or giant or ruptured lumbar disc herniation, cauda equina syndrome, foot drop, or surgery requirements;
      • Progressive neurological symptoms after 3 months of strict conservative treatment (e.g., nerve root adhesion, crossed straight-leg testing, or obvious muscle atrophy);
      • Severe cardiovascular, liver, kidney, hematopoietic system diseases, autoimmune diseases, or poor nutritional status;
      • Subjects with cognitive impairment;
      • Pregnancy;
      • Subjects who received acupuncture for sciatica within the past month.
      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).

      1 locations

      China (1)
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
        recruiting
        Beijing, China, 100053
      Status:
      unknown
      Type:
      Interventional
      Phase:
      -
      Start:
      30 April, 2016
      Updated:
      10 May, 2016
      Participants:
      60
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