Clinical trial NCT02770963: Efficacy of Acupuncture for Discogenic Sciatica
Official title: Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sciatica
Keywords: discogenic
Acupuncture Therapy
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline in mean weekly VAS of leg pain
timeFrame: Baseline, weeks 1-4, week 16 and week 28
Secondary outcomes:
measure: Change in mean weekly VAS of low back pain
timeFrame: Baseline, weeks 1-4, week 16 and week 28
measure: Oswestry disability index
timeFrame: Baseline, week 4, week 16 and week 28
measure: Patients' global impressions of improvement
timeFrame: week 4
measure: Patients' expectations for acupuncture
timeFrame: baseline
measure: Blinded evaluation
timeFrame: week 4
measure: Incidence of serious adverse events
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China
name: Qin Yao
role: PRINCIPAL_INVESTIGATOR
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