Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration (ITILO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01648738 |
Recruitment Status
:
Completed
First Posted
: July 24, 2012
Last Update Posted
: January 8, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Other: Spa therapy, exercise and educational therapy Other: Usual care | Not Applicable |
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 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | April 2016 |
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
|
- Frequency of return to work [ Time Frame: 1 year ]Frequency of return to work 1 year after the inclusion date
- 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
- Function [ Time Frame: 1 year ]Assessed with QUEBEC functional scale
- Quality of life [ Time Frame: 1 year ]Assessed with MOS SF- 12
- TWIST [ Time Frame: 1 year ]Time without symptom (without pain)
- Sick leave [ Time Frame: 1 year ]Number of sick leave days from 6 to 12 months after inclusion date

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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

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
France | |
Cochin Hospital | |
Paris, France, 75014 |
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 |
Additional Information:
Publications of Results:
Other Publications:
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 Disability Education Exercise |
Spa therapy Physiotherapy Multidisciplinary Cost-effectiveness Sick leave |
Additional relevant MeSH terms:
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |