search
Back to results

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

Primary Purpose

Subacute and Chronic Non-specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Placebo of osteopathic manipulative treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacute and Chronic Non-specific Low Back Pain focused on measuring low back pain, manual therapy, randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Osteopathic manipulative treatment

Placebo of osteopathic manipulative treatment

Arm Description

6 sessions of standardized manipulative treatment

6 sessions of standardized placebo of manipulative treatment

Outcomes

Primary Outcome Measures

Mean improvement from baseline in mean activity limitation
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)

Secondary Outcome Measures

Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain)
Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain)
Number of sick leaves
self-reported number of sick leaves
Duration of sick leaves
self-reported total duration (days) of sick leaves
Recurrence of pain
self-reported number of low back pain episodes
Mean improvement from baseline in mean activity limitation
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
Mean improvement from baseline in mean quality of life
Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
Mean improvement from baseline in mean quality of life
Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
Pain killer and non-steroidal anti-inflammatory drug consumption
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
Pain killer and non-steroidal anti-inflammatory drug consumption
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)

Full Information

First Posted
January 10, 2014
Last Updated
January 18, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Université Paris Cité, University of Paris 5 - Rene Descartes, Institut Universitaire Romand de Sante au Travail
search

1. Study Identification

Unique Protocol Identification Number
NCT02034864
Brief Title
Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain
Acronym
LC OSTEO
Official Title
Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain at 3 Months : a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2014 (Actual)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Université Paris Cité, University of Paris 5 - Rene Descartes, Institut Universitaire Romand de Sante au Travail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. Manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. The purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. A standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute and Chronic Non-specific Low Back Pain
Keywords
low back pain, manual therapy, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic manipulative treatment
Arm Type
Experimental
Arm Description
6 sessions of standardized manipulative treatment
Arm Title
Placebo of osteopathic manipulative treatment
Arm Type
Sham Comparator
Arm Description
6 sessions of standardized placebo of manipulative treatment
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo of osteopathic manipulative treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean improvement from baseline in mean activity limitation
Description
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
Time Frame
3 months after randomization
Secondary Outcome Measure Information:
Title
Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
Description
assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain)
Time Frame
3 months after randomization
Title
Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
Description
assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain)
Time Frame
12 months after randomization
Title
Number of sick leaves
Description
self-reported number of sick leaves
Time Frame
12 months after randomization
Title
Duration of sick leaves
Description
self-reported total duration (days) of sick leaves
Time Frame
12 months after randomization
Title
Recurrence of pain
Description
self-reported number of low back pain episodes
Time Frame
12 months after randomization
Title
Mean improvement from baseline in mean activity limitation
Description
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
Time Frame
12 months after randomization
Title
Mean improvement from baseline in mean quality of life
Description
Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
Time Frame
3 months after randomization
Title
Mean improvement from baseline in mean quality of life
Description
Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
Time Frame
12 months after randomization
Title
Pain killer and non-steroidal anti-inflammatory drug consumption
Description
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
Time Frame
3 months after randomization
Title
Pain killer and non-steroidal anti-inflammatory drug consumption
Description
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Rannou, MD PhD
Organizational Affiliation
AP-HP, Descartes University, INSERM
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Cochin
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
Citation
1. Poiraudeau S, Lefèvre-Colau M.-M, Fayad F., Rannou F, Revel M. Lombalgie. Encyclopédie Médico-Chirurgicale 15-840-C-10 (2004)
Results Reference
background
PubMed Identifier
17909211
Citation
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. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.
Results Reference
background
PubMed Identifier
17636686
Citation
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.
Results Reference
background
PubMed Identifier
15867409
Citation
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.
Results Reference
background
PubMed Identifier
19892856
Citation
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.
Results Reference
background
PubMed Identifier
20234040
Citation
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.
Results Reference
background
PubMed Identifier
19116007
Citation
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.
Results Reference
background
PubMed Identifier
17147594
Citation
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.
Results Reference
background
PubMed Identifier
12779297
Citation
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.
Results Reference
background
PubMed Identifier
15125860
Citation
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.
Results Reference
background
PubMed Identifier
15838072
Citation
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. Erratum In: Ann Intern Med. 2005 Jun 7;142(11):950-1.
Results Reference
background
PubMed Identifier
20229280
Citation
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.
Results Reference
background
PubMed Identifier
16080794
Citation
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.
Results Reference
background
PubMed Identifier
10547405
Citation
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.
Results Reference
background
PubMed Identifier
12838090
Citation
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.
Results Reference
background
PubMed Identifier
6453240
Citation
Hoehler FK, Tobis JS, Buerger AA. Spinal manipulation for low back pain. JAMA. 1981 May 8;245(18):1835-8.
Results Reference
background
PubMed Identifier
20332509
Citation
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.
Results Reference
background
PubMed Identifier
18283207
Citation
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.
Results Reference
background
PubMed Identifier
33720272
Citation
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.
Results Reference
derived
Links:
URL
http://whqlibdoc.who.int/publications/2010/9789241599665_eng.pdf
Description
World Health Organization Benchmarks for training in osteopathy. Novembre 2010. Site Internet de l'Organisation Mondiale de la Santé
URL
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:255:0022:0142:en:PDF
Description
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

Learn more about this trial

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

We'll reach out to this number within 24 hrs