Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an intensive 5 days long multidisciplinary program (including spa therapy, exercises and patients'education) is more effective regarding return to work than usual care in subacute and chronic low back pain for people in sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is considered

Detailed Description
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Sick leave due to low back pain (LBP) is costly and compromises workforce productivity. Sick leave itself, fears and believes regarding return to work, and a low self-esteem have been identified as independent predictors of extended sick leave. Previous data suggested that multidisciplinary rehabilitation programs, including physical activities and psychobehavioral management, should decrease sick leave duration in chronic LBP. However these programs are heavy (at least 4 weeks long), and are often proposed to patients at the end of the management (over 6 months after the beginning of symptoms). Another approach could be to propose a shorter multidisciplinary program (for example 5 days long), earlier in the history of LBP to break the vicious circle as soon as possible. The target population could be people suffering from subacute LBP with sick leave duration between 4 and 24 weeks.

Official Title
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Effectiveness of a Short, Intensive and Standardised Spa Therapy for Subacute and Chronic Low Back Pain on Return to Work for Patients in Sick Leave From 4 to 24 Weeks Duration : a Randomized Controlled Trial Using a Modified Zelen Method

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Spa therapy, exercise and educational therapy
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged from 18 to 60 years (included) Low back pain (or back and radicular pain with back pain the most painful) Sick leave between 4 and 24 weeks duration, without expected return to work A prior medical evaluation is made and the results will be communicated to the patient Patient giving his informed consent to participate in the study Patient affiliated to or beneficiary of social insurance Exclusion Criteria: Cognition or behavioral disorders making it impossible to assess Inability to speak and write French Contra-indication to perform a short spa therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spa therapy, exercise and educational therapy<br>Spa therapy, exercise and educational therapy | Other: Spa therapy, exercise and educational therapy<br>* During 5 days: Spa therapy (2 hours/day), exercises (30 min/day), educational therapy (45 min/day) including education on physical activities, work, and pain management<br>* Other names: multidisciplinary program;|
| Active Comparator: Usual care and counselling (Back book)<br>Usual care and counselling (Back book) | Other: Usual care<br>* Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of return to work | Frequency of return to work 1 year after the inclusion date | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Evaluated by the area under the curve of pain (numeric scale from 0 to 100) assessed every 2 weeks during 1 year | Every 2 weeks during 1 year | 
| Function | Assessed with QUEBEC functional scale | 1 year | 
| Quality of life | Assessed with MOS SF- 12 | 1 year | 
| TWIST | Time without symptom (without pain) | 1 year | 
| Sick leave | Number of sick leave days from 6 to 12 months after inclusion date | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subacute low back pain, Chronic low back pain, Low back pain, Disability, Education, Exercise, Spa therapy, Physiotherapy, Multidisciplinary, Cost-effectiveness, Sick leave