Clinical trial NCT01648738: Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Subacute low back pain
Chronic low back pain
Low back pain
Disability
Education
Exercise
Spa therapy
Physiotherapy
Multidisciplinary
Cost-effectiveness
Sick leave
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association Francaise pour la Recherche Thermale
First posted: 2012-07-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of return to work
timeFrame: 1 year
Secondary outcomes:
measure: Pain
timeFrame: Every 2 weeks during 1 year
measure: Function
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: TWIST
timeFrame: 1 year
measure: Sick leave
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Cochin Hospital and Descartes University, INSERM
name: Serge POIRAUDEAU, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel COUDEYRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalo-Universitaire Carémeau
name: Arnaud DUPEYRON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
name: Ygal ATTAL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Thermal de Dax
name: Jean-Max TESSIER, MD
role: PRINCIPAL_INVESTIGATOR
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