Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain

NCT02034864 | Completed

• 1 other identifier: P110142
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months.

Conditions

Subacute and Chronic Non-specific Low Back Pain

Keywords

low back pain; manual therapy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean improvement from baseline in mean activity limitation

  Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)

  3 months after randomization

Secondary Outcomes (10)

• Mean reduction from baseline in mean lumbar pain in the previous 48 hrs

  3 months after randomization

• Mean reduction from baseline in mean lumbar pain in the previous 48 hrs

  12 months after randomization

• Number of sick leaves

  12 months after randomization

• Duration of sick leaves

  12 months after randomization

• Recurrence of pain

  12 months after randomization

Study Arms (2)

Osteopathic manipulative treatment

EXPERIMENTAL

6 sessions of standardized manipulative treatment

Other: Osteopathic manipulative treatment

Placebo of osteopathic manipulative treatment

SHAM COMPARATOR

6 sessions of standardized placebo of manipulative treatment

Other: Placebo of osteopathic manipulative treatment

Interventions

Osteopathic manipulative treatment OTHER

A standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.

Osteopathic manipulative treatment

Placebo of osteopathic manipulative treatment OTHER

A standardized placebo of manipulative treatment consisting in "light touch" and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment.

Placebo of osteopathic manipulative treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consulting for subacute and chronic non-specific low
• Male or female aged from 18 to 65 years (included)
• Patient can speak and understand French
• Patient giving his informed consent to participate in the study
• Patient affiliated to or beneficiary of social insurance

You may not qualify if:

• Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
• History of back surgery and/or vertebral fracture in the previous 6 months
• Presence of a motor impairment related to the reason for consultation
• The patient is a student or a practitioner in manipulative therapies
• Pregnancy
• Inability to understand the process of the study
• The patient is already included in another clinical study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Université Paris Cité: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• Institut Universitaire Romand de Sante au Travail: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

CHU Cochin

Paris, 75014, France

Location

Related Publications (19)

• Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001/jamainternmed.2021.0005.

  PMID: 33720272 BACKGROUND

• 1. Poiraudeau S, Lefèvre-Colau M.-M, Fayad F., Rannou F, Revel M. Lombalgie. Encyclopédie Médico-Chirurgicale 15-840-C-10 (2004)

  BACKGROUND

• Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.

  PMID: 17909211 BACKGROUND

• Nelemans PJ, de Bie RA, de Vet HC, Sturmans F. WITHDRAWN: Injection therapy for subacute and chronic benign low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(2):CD001824. doi: 10.1002/14651858.CD001824.pub2.

  PMID: 17636686 BACKGROUND

• Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.

  PMID: 15867409 BACKGROUND

• Costa LO, Maher CG, Latimer J, Hodges PW, Herbert RD, Refshauge KM, McAuley JH, Jennings MD. Motor control exercise for chronic low back pain: a randomized placebo-controlled trial. Phys Ther. 2009 Dec;89(12):1275-86. doi: 10.2522/ptj.20090218. Epub 2009 Nov 5.

  PMID: 19892856 BACKGROUND

• Lambeek LC, van Mechelen W, Knol DL, Loisel P, Anema JR. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life. BMJ. 2010 Mar 16;340:c1035. doi: 10.1136/bmj.c1035.

  PMID: 20234040 BACKGROUND

• Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.

  PMID: 19116007 BACKGROUND

• Macario A, Pergolizzi JV. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain. Pain Pract. 2006 Sep;6(3):171-8. doi: 10.1111/j.1533-2500.2006.00082.x.

  PMID: 17147594 BACKGROUND

• Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.

  PMID: 12779297 BACKGROUND

• Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.

  PMID: 15125860 BACKGROUND

• Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005 Apr 19;142(8):651-63. doi: 10.7326/0003-4819-142-8-200504190-00014.

  PMID: 15838072 BACKGROUND

• Rubinstein SM, van Middelkoop M, Kuijpers T, Ostelo R, Verhagen AP, de Boer MR, Koes BW, van Tulder MW. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain. Eur Spine J. 2010 Aug;19(8):1213-28. doi: 10.1007/s00586-010-1356-3. Epub 2010 Mar 14.

  PMID: 20229280 BACKGROUND

• Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.

  PMID: 16080794 BACKGROUND

• Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.

  PMID: 10547405 BACKGROUND

• Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.

  PMID: 12838090 BACKGROUND

• Hoehler FK, Tobis JS, Buerger AA. Spinal manipulation for low back pain. JAMA. 1981 May 8;245(18):1835-8.

  PMID: 6453240 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

• Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309. doi: 10.7326/0003-4819-148-4-200802190-00008.

  PMID: 18283207 BACKGROUND

Related Links

• World Health Organization Benchmarks for training in osteopathy. Novembre 2010. Site Internet de l'Organisation Mondiale de la Santé
• Official Journal of the European Union Website. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications p. 22-142

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Francois Rannou, MD PhD

  AP-HP, Descartes University, INSERM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: February 17, 2014
• Primary Completion: October 23, 2017
• Study Completion: October 23, 2017
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

FR (1)