- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01648738
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
Status
Completed
Conditions
Intervention / Treatment
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
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-
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Paris, France, 75014
- Cochin Hospital
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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:
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ACTIVE_COMPARATOR: Usual care and counselling (Back book)
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Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book
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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
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Every 2 weeks during 1 year
|
Function
Time Frame: 1 year
|
Assessed with QUEBEC functional scale
|
1 year
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Quality of life
Time Frame: 1 year
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Assessed with MOS SF- 12
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1 year
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TWIST
Time Frame: 1 year
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Time without symptom (without pain)
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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.
Collaborators
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
- Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
- Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
- Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004 Jun;57(6):543-50. doi: 10.1016/j.jclinepi.2003.12.010.
- Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007 Feb;4(2):e61. doi: 10.1371/journal.pmed.0040061.
- Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309. doi: 10.7326/0003-4819-148-4-200802190-00008.
- Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.
- Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
- Druss BG, Rosenheck RA, Sledge WH. Health and disability costs of depressive illness in a major U.S. corporation. Am J Psychiatry. 2000 Aug;157(8):1274-8. doi: 10.1176/appi.ajp.157.8.1274.
- Hansson TH, Hansson EK. The effects of common medical interventions on pain, back function, and work resumption in patients with chronic low back pain: A prospective 2-year cohort study in six countries. Spine (Phila Pa 1976). 2000 Dec 1;25(23):3055-64. doi: 10.1097/00007632-200012010-00013.
- Magnussen L, Nilsen S, Raheim M. Barriers against returning to work--as perceived by disability pensioners with back pain: a focus group based qualitative study. Disabil Rehabil. 2007 Feb 15;29(3):191-7. doi: 10.1080/09638280600747793.
- Costa Lda C, Maher CG, McAuley JH, Hancock MJ, Herbert RD, Refshauge KM, Henschke N. Prognosis for patients with chronic low back pain: inception cohort study. BMJ. 2009 Oct 6;339:b3829. doi: 10.1136/bmj.b3829.
- Nguyen M, Revel M, Dougados M. Prolonged effects of 3 week therapy in a spa resort on lumbar spine, knee and hip osteoarthritis: follow-up after 6 months. A randomized controlled trial. Br J Rheumatol. 1997 Jan;36(1):77-81. doi: 10.1093/rheumatology/36.1.77.
- Quilty B, Tucker M, Campbell R, Dieppe P. Physiotherapy, including quadriceps exercises and patellar taping, for knee osteoarthritis with predominant patello-femoral joint involvement: randomized controlled trial. J Rheumatol. 2003 Jun;30(6):1311-7.
- Poiraudeau S, Rannou F, Le Henanff A, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Revel M, Ravaud P. Outcome of subacute low back pain: influence of patients' and rheumatologists' characteristics. Rheumatology (Oxford). 2006 Jun;45(6):718-23. doi: 10.1093/rheumatology/kei231. Epub 2005 Dec 23.
- Reme SE, Hagen EM, Eriksen HR. Expectations, perceptions, and physiotherapy predict prolonged sick leave in subacute low back pain. BMC Musculoskelet Disord. 2009 Nov 13;10:139. doi: 10.1186/1471-2474-10-139.
- Roberts PJ, Roberts C, Sibbald B, Torgerson DJ. Increasing response rates to postal questionnaires. Effect of incentives on response rates must be considered. BMJ. 2002 Aug 24;325(7361):444. No abstract available.
- Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
- Schonstein E, Kenny DT, Keating J, Koes BW. Work conditioning, work hardening and functional restoration for workers with back and neck pain. Cochrane Database Syst Rev. 2003;(1):CD001822. doi: 10.1002/14651858.CD001822.
- Waddell G, Burton AK. Occupational health guidelines for the management of low back pain at work: evidence review. Occup Med (Lond). 2001 Mar;51(2):124-35. doi: 10.1093/occmed/51.2.124.
- Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008 Mar 15;336(7644):601-5. doi: 10.1136/bmj.39465.451748.AD. Epub 2008 Mar 3.
- Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M, Hurri H, Koes B. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working age adults. Cochrane Database Syst Rev. 2003;(2):CD002193. doi: 10.1002/14651858.CD002193.
- Anema JR, Steenstra IA, Bongers PM, de Vet HC, Knol DL, Loisel P, van Mechelen W. Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial. Spine (Phila Pa 1976). 2007 Feb 1;32(3):291-8; discussion 299-300. doi: 10.1097/01.brs.0000253604.90039.ad.
- Nguyen C, Boutron I, Rein C, Baron G, Sanchez K, Palazzo C, Dupeyron A, Tessier JM, Coudeyre E, Eschalier B, Forestier R, Roques-Latrille CF, Attal Y, Lefevre-Colau MM, Rannou F, Poiraudeau S. Intensive spa and exercise therapy program for returning to work for low back pain patients: a randomized controlled trial. Sci Rep. 2017 Dec 20;7(1):17956. doi: 10.1038/s41598-017-18311-z.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/04
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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