Efficacy of Acupuncture for Discogenic Sciatica

May 11, 2016 updated by: Qin Yao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial

This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, weeks 1-4, week 16 and week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, weeks 1-4, week 16 and week 28
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
Baseline, week 4, week 16 and week 28
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).
week 4
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 .
baseline
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.
week 4
Incidence of serious adverse events
Time Frame: up to 28 weeks
The investigators will record and evaluate all adverse events .
up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Principal Investigator: Qin Yao, Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016010401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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