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

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ClinicalTrials.gov Identifier: NCT02034864
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Sorbonne Paris Cité
University of Paris 5 - Rene Descartes
Institut Universitaire Romand de Sante au Travail
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Subacute and Chronic Non-specific Low Back Pain Other: Osteopathic manipulative treatment Other: Placebo of osteopathic manipulative treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : February 17, 2014
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : October 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Osteopathic manipulative treatment
6 sessions of standardized manipulative treatment
Other: Osteopathic manipulative treatment
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.

Sham Comparator: Placebo of osteopathic manipulative treatment
6 sessions of standardized placebo of manipulative treatment
Other: Placebo of osteopathic manipulative treatment
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 Measures :
  1. Mean improvement from baseline in mean activity limitation [ Time Frame: 3 months after randomization ]
    Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)


Secondary Outcome Measures :
  1. Mean reduction from baseline in mean lumbar pain in the previous 48 hrs [ Time Frame: 3 months after randomization ]
    assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain)

  2. Mean reduction from baseline in mean radicular pain in the previous 48 hrs [ Time Frame: 3 months after randomization ]
    assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain)

  3. Mean reduction from baseline in mean lumbar pain in the previous 48 hrs [ Time Frame: 12 months after randomization ]
    assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain)

  4. Mean reduction from baseline in mean radicular pain in the previous 48 hrs [ Time Frame: 12 months after randomization ]
    assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain)

  5. Number of sick leaves [ Time Frame: 12 months after randomization ]
    self-reported number of sick leaves

  6. Duration of sick leaves [ Time Frame: 12 months after randomization ]
    self-reported total duration (days) of sick leaves

  7. Recurrence of pain [ Time Frame: 12 months after randomization ]
    self-reported number of low back pain episodes

  8. Mean improvement from baseline in mean activity limitation [ Time Frame: 12 months after randomization ]
    Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)

  9. Mean improvement from baseline in mean quality of life [ Time Frame: 3 months after randomization ]
    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)

  10. Mean improvement from baseline in mean quality of life [ Time Frame: 12 months after randomization ]
    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)

  11. Pain killer and non-steroidal anti-inflammatory drug consumption [ Time Frame: 3 months after randomization ]
    self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)

  12. Pain killer and non-steroidal anti-inflammatory drug consumption [ Time Frame: 12 months after randomization ]
    self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02034864


Locations
France
CHU Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Sorbonne Paris Cité
University of Paris 5 - Rene Descartes
Institut Universitaire Romand de Sante au Travail
Investigators
Principal Investigator: Francois Rannou, MD PhD AP-HP, Descartes University, INSERM

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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02034864     History of Changes
Other Study ID Numbers: P110142
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
low back pain
manual therapy
randomized controlled trial

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms