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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Subacute and Chronic Non-specific Low Back Pain

Treatments: Other: Osteopathic manipulative treatment; Other: Placebo of osteopathic manipulative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02034864

P110142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Osteopathic manipulative treatment

Experimental group

Description:

6 sessions of standardized manipulative treatment

Treatment:

Other: Osteopathic manipulative treatment

Placebo of osteopathic manipulative treatment

Sham Comparator group

Description:

6 sessions of standardized placebo of manipulative treatment

Treatment:

Other: Placebo of osteopathic manipulative treatment