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Efficacy of Acupuncture for Discogenic Sciatica

Primary Purpose

Sciatica

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acupuncture

Sham acupuncture

About this trial

This is an interventional treatment trial for Sciatica focused on measuring discogenic, Acupuncture Therapy, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

change from baseline in mean weekly VAS of leg pain

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

Change in mean weekly VAS of low back pain

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

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

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

Patients' expectations for acupuncture

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

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

The investigators will record and evaluate all adverse events .

Full Information

NCT ID

NCT02770963

First Posted

May 5, 2016

Last Updated

May 11, 2016

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02770963

Brief Title

Efficacy of Acupuncture for Discogenic Sciatica

Official Title

Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sciatica

Keywords

discogenic, Acupuncture Therapy, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sham acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

change from baseline in mean weekly VAS of leg pain

Description

Time Frame

Baseline, weeks 1-4, week 16 and week 28

Secondary Outcome Measure Information:

Title

Change in mean weekly VAS of low back pain

Description

Time Frame

Baseline, weeks 1-4, week 16 and week 28

Title

Oswestry disability index

Description

Time Frame

Baseline, week 4, week 16 and week 28

Title

Patients' global impressions of improvement

Description

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

Time Frame

week 4

Title

Patients' expectations for acupuncture

Description

Time Frame

baseline

Title

Blinded evaluation

Description

Time Frame

week 4

Title

Incidence of serious adverse events

Description

The investigators will record and evaluate all adverse events .

Time Frame

up to 28 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qin Yao

Phone

+86-15650728152

1126873424@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhishun Liu

Phone

+86-10-88001124

liuzhishun@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qin Yao

Organizational Affiliation

Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

City

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qin Yao

Phone

+86-15650728152

1126873424@qq.com

First Name & Middle Initial & Last Name & Degree

Zhishun Liu

Phone

+86-10-88001124

liuzhishun@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

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17585160

Citation

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Efficacy of Acupuncture for Discogenic Sciatica

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