NCT02770963

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

May 5, 2016

Last Update Submit

May 11, 2016

Conditions

Sciatica

Keywords

discogenicAcupuncture Therapyrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (6)

  • Change in mean weekly VAS of low back pain

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

  • Oswestry disability index

    Baseline, week 4, week 16 and week 28

  • Patients' global impressions of improvement

    week 4

  • Patients' expectations for acupuncture

    baseline

  • Blinded evaluation

    week 4

  • +1 more secondary outcomes

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Sham acupuncture

SHAM COMPARATOR

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

Interventions

AcupuncturePROCEDURE

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.

Acupuncture
Sham acupuncturePROCEDURE

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.

Sham acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

RECRUITING

Related Publications (16)

  • Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. 2007 Jun 23;334(7607):1313-7. doi: 10.1136/bmj.39223.428495.BE. No abstract available.

    PMID: 17585160BACKGROUND

  • Valat JP, Genevay S, Marty M, Rozenberg S, Koes B. Sciatica. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):241-52. doi: 10.1016/j.berh.2009.11.005.

    PMID: 20227645BACKGROUND

  • Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.

    PMID: 25806916BACKGROUND

  • Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.

    PMID: 22078311BACKGROUND

  • Asche CV, Kirkness CS, McAdam-Marx C, Fritz JM. The societal costs of low back pain: data published between 2001 and 2007. J Pain Palliat Care Pharmacother. 2007;21(4):25-33.

    PMID: 18032313BACKGROUND

  • Thomas KC, Fisher CG, Boyd M, Bishop P, Wing P, Dvorak MF. Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1414-22. doi: 10.1097/BRS.0b013e318060a5d1.

    PMID: 17545909BACKGROUND

  • Ji M, Wang X, Chen M, Shen Y, Zhang X, Yang J. The Efficacy of Acupuncture for the Treatment of Sciatica: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:192808. doi: 10.1155/2015/192808. Epub 2015 Sep 6.

    PMID: 26425130BACKGROUND

  • Qin Z, Liu X, Wu J, Zhai Y, Liu Z. Effectiveness of Acupuncture for Treating Sciatica: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:425108. doi: 10.1155/2015/425108. Epub 2015 Oct 21.

    PMID: 26576192BACKGROUND

  • Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.

    PMID: 24239490BACKGROUND

  • MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Altern Complement Med. 2010 Oct;16(10):ST1-14. doi: 10.1089/acm.2010.1610.

    PMID: 20954957BACKGROUND

  • Liu B, Xu H, Ma R, Mo Q, Yan S, Liu Z. Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study. Medicine (Baltimore). 2014 Dec;93(27):e200. doi: 10.1097/MD.0000000000000200.

    PMID: 25501074BACKGROUND

  • Porchet F, Wietlisbach V, Burnand B, Daeppen K, Villemure JG, Vader JP. Relationship between severity of lumbar disc disease and disability scores in sciatica patients. Neurosurgery. 2002 Jun;50(6):1253-9; discussion 1259-60. doi: 10.1097/00006123-200206000-00014.

    PMID: 12015843BACKGROUND

  • Cohen SP, Bogduk N, Dragovich A, Buckenmaier CC 3rd, Griffith S, Kurihara C, Raymond J, Richter PJ, Williams N, Yaksh TL. Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology. 2009 May;110(5):1116-26. doi: 10.1097/ALN.0b013e3181a05aa0.

    PMID: 19387178BACKGROUND

  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

    PMID: 11074683BACKGROUND

  • Sherman KJ, Cherkin DC, Ichikawa L, Avins AL, Delaney K, Barlow WE, Khalsa PS, Deyo RA. Treatment expectations and preferences as predictors of outcome of acupuncture for chronic back pain. Spine (Phila Pa 1976). 2010 Jul 1;35(15):1471-7. doi: 10.1097/BRS.0b013e3181c2a8d3.

    PMID: 20535051BACKGROUND

  • Bartels DJ, van Laarhoven AI, van de Kerkhof PC, Evers AW. Placebo and nocebo effects on itch: effects, mechanisms, and predictors. Eur J Pain. 2016 Jan;20(1):8-13. doi: 10.1002/ejp.750. Epub 2015 Sep 28.

    PMID: 26417885BACKGROUND

MeSH Terms

Conditions

Sciatica

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Qin Yao

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Yao

CONTACT

+86-156507281521126873424@qq.com

Zhishun Liu

CONTACT

+86-10-88001124liuzhishun@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 12, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)