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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01648738
Acronym
ITILO
Enrollment
88
Registered
2012-07-24
Start date
2012-07-31
Completion date
2016-04-30
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERSpa therapy, exercise and educational therapy

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

OTHERUsual care

Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book

Sponsors

Association Francaise pour la Recherche Thermale
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of return to work1 yearFrequency of return to work 1 year after the inclusion date

Secondary

MeasureTime frameDescription
PainEvery 2 weeks during 1 yearEvaluated by the area under the curve of pain (numeric scale from 0 to 100) assessed every 2 weeks during 1 year
Function1 yearAssessed with QUEBEC functional scale
Quality of life1 yearAssessed with MOS SF- 12
TWIST1 yearTime without symptom (without pain)
Sick leave1 yearNumber of sick leave days from 6 to 12 months after inclusion date

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026