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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: Spa therapy, exercise and educational therapy; Other: Usual care	Not Applicable

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Frequency of return to work [ Time Frame: 1 year ]
   Frequency of return to work 1 year after the inclusion date

Secondary Outcome Measures :

1. 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
2. Function [ Time Frame: 1 year ]
   Assessed with QUEBEC functional scale
3. Quality of life [ Time Frame: 1 year ]
   Assessed with MOS SF- 12
4. TWIST [ Time Frame: 1 year ]
   Time without symptom (without pain)
5. Sick leave [ Time Frame: 1 year ]
   Number of sick leave days from 6 to 12 months after inclusion date

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Additional Information:

Related Info 

Publications of Results:

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, Lefèvre-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.

Other Publications:

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

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.

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. 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.

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. 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.

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. doi: 10.1136/bmj.39465.451748.AD. 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. Update in: Cochrane Database Syst Rev. 2017 Jun 28;6: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.

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
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