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Trial record 53 of 1170 for:    acupuncture

Efficacy of Acupuncture for Discogenic Sciatica

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ClinicalTrials.gov Identifier: NCT02770963
Recruitment Status : Unknown
Verified May 2016 by Qin Yao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Qin Yao, 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.

Condition or disease Intervention/treatment Phase
Sciatica Procedure: Acupuncture Procedure: Sham acupuncture Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Sciatica

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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).

  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 .

  5. 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.

  6. Incidence of serious adverse events [ Time Frame: up to 28 weeks ]
    The investigators will record and evaluate all adverse events .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770963


Contacts
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Contact: Qin Yao +86-15650728152 1126873424@qq.com
Contact: Zhishun Liu +86-10-88001124 liuzhishun@aliyun.com

Locations
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China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, China, 100053
Contact: Qin Yao    +86-15650728152    1126873424@qq.com   
Contact: Zhishun Liu    +86-10-88001124    liuzhishun@aliyun.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Qin Yao Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China

Publications:

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Responsible Party: Qin Yao, Postgraduate, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02770963     History of Changes
Other Study ID Numbers: 2016010401
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Qin Yao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
discogenic
Acupuncture Therapy
randomized controlled trial

Additional relevant MeSH terms:
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Sciatica
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms