Subacute and Chronic Non-specific Low Back Pain Clinical Trial
— LC OSTEOOfficial 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
| Verified date | January 2019 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | October 23, 2017 |
| Est. primary completion date | October 23, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Cochin | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France, Institut Universitaire Romand de Sante au Travail, Sorbonne Paris Cité, University of Paris 5 - Rene Descartes |
France,
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* Note: There are 18 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | 3 months after randomization | |
| Secondary | 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) | 12 months after randomization | |
| Secondary | Number of sick leaves | self-reported number of sick leaves | 12 months after randomization | |
| Secondary | Duration of sick leaves | self-reported total duration (days) of sick leaves | 12 months after randomization | |
| Secondary | Recurrence of pain | self-reported number of low back pain episodes | 12 months after randomization | |
| Secondary | Mean improvement from baseline in mean activity limitation | Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation) | 12 months after randomization | |
| Secondary | 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) | 3 months after randomization | |
| Secondary | 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) | 12 months after randomization | |
| Secondary | 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) | 3 months after randomization | |
| Secondary | 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) | 12 months after randomization |