Clinical Trial: Efficacy of Acupuncture for Discogenic Sciatica
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial
Brief Summary: This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.
Detailed Summary:
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).
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Current Primary Outcome: change from baseline in mean weekly VAS of leg pain [ Time Frame: Baseline, weeks 1-4, week 16 and week 28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 .
Original Secondary Outcome: Same as current
Information By: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Dates:
Date Received: May 5, 2016
Date Started: May 2016
Date Completion: June 2018
Last Updated: May 11, 2016
Last Verified: May 2016