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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Spa therapy, exercise and educational therapy; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01648738

2010/04

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

88 participants in 2 patient groups

Spa therapy, exercise and educational therapy

Experimental group

Description:

Spa therapy, exercise and educational therapy

Treatment:

Other: Spa therapy, exercise and educational therapy

Usual care and counselling (Back book)

Active Comparator group

Description:

Usual care and counselling (Back book)

Treatment:

Other: Usual care