NCT01648738

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

3.4 years

First QC Date

July 20, 2012

Last Update Submit

January 4, 2018

Conditions

Low Back Pain

Keywords

Subacute low back painChronic low back painLow back painDisabilityEducationExerciseSpa therapyPhysiotherapyMultidisciplinaryCost-effectivenessSick leave

Outcome Measures

Primary Outcomes (1)

  • Frequency of return to work

    Frequency of return to work 1 year after the inclusion date

    1 year

Secondary Outcomes (5)

  • Pain

    Every 2 weeks during 1 year

  • Function

    1 year

  • Quality of life

    1 year

  • TWIST

    1 year

  • Sick leave

    1 year

Study Arms (2)

Spa therapy, exercise and educational therapy

EXPERIMENTAL

Spa therapy, exercise and educational therapy

Other: Spa therapy, exercise and educational therapy

Usual care and counselling (Back book)

ACTIVE COMPARATOR

Usual care and counselling (Back book)

Other: Usual care

Interventions

Spa therapy, exercise and educational therapyOTHER

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

Also known as: multidisciplinary program
Spa therapy, exercise and educational therapy
Usual careOTHER

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

Usual care and counselling (Back book)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Cognition or behavioral disorders making it impossible to assess
  • Inability to speak and write French
  • Contra-indication to perform a short spa therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (23)

  • 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.

    PMID: 10470716BACKGROUND

  • 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.

    PMID: 15246122BACKGROUND

  • 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.

    PMID: 17311468BACKGROUND

  • 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.

    PMID: 18283207BACKGROUND

  • 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.

    PMID: 17684553BACKGROUND

  • 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.

    PMID: 19734131BACKGROUND

  • 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.

    PMID: 10910790BACKGROUND

  • 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.

    PMID: 11145817BACKGROUND

  • 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.

    PMID: 17364769BACKGROUND

  • 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.

    PMID: 19808766BACKGROUND

  • 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.

    PMID: 9117181BACKGROUND

  • 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.

    PMID: 12784408BACKGROUND

  • 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.

    PMID: 16377729BACKGROUND

  • 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.

    PMID: 19912626BACKGROUND

  • 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.

    PMID: 12201284BACKGROUND

  • 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.

    PMID: 19502217BACKGROUND

  • 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.

    PMID: 12535416BACKGROUND

  • 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.

    PMID: 11307688BACKGROUND

  • 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.

    PMID: 18316340BACKGROUND

  • 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.

    PMID: 19001484BACKGROUND

  • 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.

    PMID: 12804427BACKGROUND

  • 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.

    PMID: 17268258BACKGROUND

  • 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.

    PMID: 29263353RESULT

Related Links

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

FR(1)