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

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ClinicalTrials.gov Identifier: NCT01648738
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : January 8, 2018
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Low Back Pain Other: Spa therapy, exercise and educational therapy Other: Usual care

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2012
Primary Completion Date : December 2015
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Spa therapy, exercise and educational therapy
Spa therapy, exercise and educational therapy
Other: 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 Name: multidisciplinary program
Active Comparator: Usual care and counselling (Back book)
Usual care and counselling (Back book)
Other: Usual care
Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book

Outcome Measures

Primary Outcome Measures :
  1. Frequency of return to work [ Time Frame: 1 year ]
    Frequency of return to work 1 year after the inclusion date

Secondary Outcome Measures :
  1. 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

  2. Function [ Time Frame: 1 year ]
    Assessed with QUEBEC functional scale

  3. Quality of life [ Time Frame: 1 year ]
    Assessed with MOS SF- 12

  4. TWIST [ Time Frame: 1 year ]
    Time without symptom (without pain)

  5. Sick leave [ Time Frame: 1 year ]
    Number of sick leave days from 6 to 12 months after inclusion date

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648738

Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association Francaise pour la Recherche Thermale
Principal Investigator: Serge POIRAUDEAU, MD PhD Cochin Hospital and Descartes University, INSERM
Principal Investigator: Emmanuel COUDEYRE, MD, PhD University Hospital, Clermont-Ferrand
Principal Investigator: Arnaud DUPEYRON, MD, PhD Groupe Hospitalo-Universitaire Carémeau
Principal Investigator: Ygal ATTAL, MD
Principal Investigator: Jean-Max TESSIER, MD Hôpital Thermal de Dax
More Information

Additional Information:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648738     History of Changes
Other Study ID Numbers: 2010/04
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Subacute low back pain
Chronic low back pain
Low back pain
Spa therapy
Sick leave

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms