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

January 4, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Spa 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
Other Names:
  • multidisciplinary program
ACTIVE_COMPARATOR: Usual care and counselling (Back book)
Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 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
Every 2 weeks during 1 year
Function
Time Frame: 1 year
Assessed with QUEBEC functional scale
1 year
Quality of life
Time Frame: 1 year
Assessed with MOS SF- 12
1 year
TWIST
Time Frame: 1 year
Time without symptom (without pain)
1 year
Sick leave
Time Frame: 1 year
Number of sick leave days from 6 to 12 months after inclusion date
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Serge POIRAUDEAU, MD PhD, Cochin Hospital and Descartes University, INSERM
  • Principal Investigator: Arnaud DUPEYRON, MD, PhD, Groupe hospitalo-universitaire Caremeau
  • Principal Investigator: Ygal ATTAL, MD
  • Principal Investigator: Jean-Max TESSIER, MD, Hôpital Thermal de Dax

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (ESTIMATE)

July 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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