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Efficacy of Acupuncture for Discogenic Sciatica

Not Applicable
Conditions
Sciatica
Registration Number
NCT02770963
Lead Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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 Description

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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
Inclusion Criteria
  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.
Exclusion Criteria
  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;
  5. Pregnancy;
  6. Subjects who received acupuncture for sciatica within the past month.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
change from baseline in mean weekly VAS of leg painBaseline, 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.

Secondary Outcome Measures
NameTimeMethod
Change in mean weekly VAS of low back painBaseline, 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 indexBaseline, 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 improvementweek 4

Patients' global impressions of improvement measured using a Likert 7-point scale (higher scores indicate worse outcome).

Patients' expectations for acupuncturebaseline

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 evaluationweek 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 eventsup to 28 weeks

The investigators will record and evaluate all adverse events .

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

🇨🇳

Beijing, China

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, China
Qin Yao
Contact
+86-15650728152
1126873424@qq.com
Zhishun Liu
Contact
+86-10-88001124
liuzhishun@aliyun.com

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