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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Usual care; Other: Spa therapy, exercise and educational therapy

• Registration Number: NCT01648738
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care and counselling (Back book)	Usual care	Usual care and counselling (Back book)
Spa therapy, exercise and educational therapy	Spa therapy, exercise and educational therapy	Spa therapy, exercise and educational therapy

Primary Outcome Measures

Name	Time	Method
Frequency of return to work	1 year	Frequency of return to work 1 year after the inclusion date

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France