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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Association Francaise pour la Recherche Thermale
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648738
First received: July 20, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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 Intervention
Low Back Pain
Other: Spa therapy, exercise and educational therapy
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Frequency of return to work [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frequency of return to work 1 year after the inclusion date


Secondary Outcome Measures:
  • Pain [ Time Frame: Every 2 weeks during 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessed with QUEBEC functional scale

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed with MOS SF- 12

  • TWIST [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time without symptom (without pain)

  • Sick leave [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of sick leave days from 6 to 12 months after inclusion date


Enrollment: 88
Study Start Date: July 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648738

Locations
France
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association Francaise pour la Recherche Thermale
Investigators
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

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648738     History of Changes
Other Study ID Numbers: 2010/04
Study First Received: July 20, 2012
Last Updated: October 20, 2014
Health Authority: France: Ministry of Health

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014