Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration - Full Text View

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:

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

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

Estimated Enrollment:	700
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	June 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

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

Contacts

Contact: Serge Poiraudeau, MD, PhD	+ 33 1 58 41 25 49	serge.poiraudeau@cch.aphp.fr
Contact: Laurence Lecomte, PhD	+33 1 71 19 64 94	laurence.lecomte@nck.aphp.fr

Locations

France
Cochin Hospital	Recruiting
Paris, France, 75014
Contact: Katherine Sanchez, MD + 33 1 58 41 25 43 katherine.sanchez@cch.aphp.fr
Principal Investigator: Serge POIRAUDEAU, MD, PhD

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:

Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. Review.

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Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007 Feb;4(2):e61. Review.

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.

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.

Forestier R, Desfour H, Tessier JM, Françon 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. 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.

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.

Magnussen L, Nilsen S, Råheim 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.

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.

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. 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.

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.

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.

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. Review. Update in: Cochrane Database Syst Rev. 2010;(1):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. Review.

Wood L, Egger M, Gluud LL, Schulz KF, Jüni 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. Epub 2008 Mar 3.

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.

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. Review.

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.

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:	May 22, 2013
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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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