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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spa therapy, exercise and educational therapy
Usual care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Subacute low back pain, Chronic low back pain, Low back pain, Disability, Education, Exercise, Spa therapy, Physiotherapy, Multidisciplinary, Cost-effectiveness, Sick leave

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spa therapy, exercise and educational therapy

Usual care and counselling (Back book)

Arm Description

Spa therapy, exercise and educational therapy

Usual care and counselling (Back book)

Outcomes

Primary Outcome Measures

Frequency of return to work
Frequency of return to work 1 year after the inclusion date

Secondary Outcome Measures

Pain
Evaluated by the area under the curve of pain (numeric scale from 0 to 100) assessed every 2 weeks during 1 year
Function
Assessed with QUEBEC functional scale
Quality of life
Assessed with MOS SF- 12
TWIST
Time without symptom (without pain)
Sick leave
Number of sick leave days from 6 to 12 months after inclusion date

Full Information

First Posted
July 20, 2012
Last Updated
January 4, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association Francaise pour la Recherche Thermale
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1. Study Identification

Unique Protocol Identification Number
NCT01648738
Brief Title
Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration
Acronym
ITILO
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association Francaise pour la Recherche Thermale

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spa therapy, exercise and educational therapy
Arm Type
Experimental
Arm Description
Spa therapy, exercise and educational therapy
Arm Title
Usual care and counselling (Back book)
Arm Type
Active Comparator
Arm Description
Usual care and counselling (Back book)
Intervention Type
Other
Intervention Name(s)
Spa therapy, exercise and educational therapy
Other Intervention Name(s)
multidisciplinary program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book
Primary Outcome Measure Information:
Title
Frequency of return to work
Description
Frequency of return to work 1 year after the inclusion date
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pain
Description
Evaluated by the area under the curve of pain (numeric scale from 0 to 100) assessed every 2 weeks during 1 year
Time Frame
Every 2 weeks during 1 year
Title
Function
Description
Assessed with QUEBEC functional scale
Time Frame
1 year
Title
Quality of life
Description
Assessed with MOS SF- 12
Time Frame
1 year
Title
TWIST
Description
Time without symptom (without pain)
Time Frame
1 year
Title
Sick leave
Description
Number of sick leave days from 6 to 12 months after inclusion date
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge POIRAUDEAU, MD PhD
Organizational Affiliation
Cochin Hospital and Descartes University, INSERM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel COUDEYRE, MD, PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnaud DUPEYRON, MD, PhD
Organizational Affiliation
Groupe Hospitalo-Universitaire Carémeau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ygal ATTAL, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Max TESSIER, MD
Organizational Affiliation
Hôpital Thermal de Dax
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29263353
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Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration

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