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Completed

NCT Number: NCT02034864

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

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.

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Key information

Conditions

Subacute and Chronic Non-specific Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 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)

  3. Number of sick leaves

    Time frame: 12 months after randomization

    self-reported number of sick leaves

  4. Duration of sick leaves

    Time frame: 12 months after randomization

    self-reported total duration (days) of sick leaves

  5. Recurrence of pain

    Time frame: 12 months after randomization

    self-reported number of low back pain episodes

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study 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

Acronym: LC OSTEO

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2014
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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