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

Low Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648738
• Other study ID #: 2010/04
• Status: Completed
• Phase: N/A
• First received: July 20, 2012
• Last updated: January 4, 2018
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• Usual care
Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

References & Publications (23)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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 wo — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

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

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