Low Back PainITILONCT01648738
Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration
A study testing Spa therapy, exercise and educational therapy in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Spa therapy, exercise and educational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cognition or behavioral disorders making it impossible to assess
- Inability to speak and write French
- Contra-indication to perform a short spa therapy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Spa therapy, exercise and educational therapy, Usual care
- Keywords
- Subacute low back pain, Chronic low back pain, Low back pain, Disability, Education, Exercise, Spa therapy, Physiotherapy, Multidisciplinary, Cost-effectiveness, Sick leave
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa therapy, exercise and educational therapyOther
Also called multidisciplinary program
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 careOther
Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book
| Study group | Role | What they receive |
|---|---|---|
| Spa therapy, exercise and educational therapy | Experimental | Spa therapy, exercise and educational therapy Receives: Other: Spa therapy, exercise and educational therapy |
| Usual care and counselling (Back book) | Active comparator | Usual care and counselling (Back book) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of return to work
Frequency of return to work 1 year after the inclusion date
Measured: 1 year
Secondary outcomes (5)
Pain
Evaluated by the area under the curve of pain (numeric scale from 0 to 100) assessed every 2 weeks during 1 year
Measured: Every 2 weeks during 1 year
Function
Assessed with QUEBEC functional scale
Measured: 1 year
Quality of life
Assessed with MOS SF- 12
Measured: 1 year
TWIST
Time without symptom (without pain)
Measured: 1 year
Sick leave
Number of sick leave days from 6 to 12 months after inclusion date
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale
- Responsible party
- Sponsor
- Investigators
- Serge POIRAUDEAU, MD PhD, Principal investigator, Cochin Hospital and Descartes University, INSERMEmmanuel COUDEYRE, MD, PhD, Principal investigator, University Hospital, Clermont-FerrandArnaud DUPEYRON, MD, PhD, Principal investigator, Groupe Hospitalo-Universitaire CarémeauYgal ATTAL, MD, Principal investigatorJean-Max TESSIER, MD, Principal investigator, Hôpital Thermal de Dax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648738
- Sponsor's protocol ID
- 2010/04
- Acronym
- ITILO
- Status last verified
- Jan 2018
- First submitted
- 20 Jul 2012
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10470716Boutron 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.
PubMed 15246122Boutron 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.
PubMed 17311468Boutron 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.
PubMed 18283207Coudeyre 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.
PubMed 17684553Forestier 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.
PubMed 19734131Druss 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.
PubMed 10910790Hansson 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.
PubMed 11145817Magnussen 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.
PubMed 17364769Costa 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.
PubMed 19808766Nguyen 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.
PubMed 9117181Quilty 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.
PubMed 12784408Poiraudeau 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.
PubMed 16377729Reme 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.
PubMed 19912626Roberts 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.
PubMed 12201284
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01648738
- Acronym / sponsor ID
- ITILO / 2010/04
- Conditions
- Low Back Pain
- Keywords
- Subacute low back pain, Chronic low back pain, Low back pain, Disability, Education, Exercise, Spa therapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spa therapy, exercise and educational therapy | Experimental | Other: Spa therapy, exercise and educational therapySpa therapy, exercise and educational therapy |
| Usual care and counselling (Back book) | Active comparator | Other: Usual careUsual care and counselling (Back book) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Cognition or behavioral disorders making it impossible to assess
- Inability to speak and write French
- Contra-indication to perform a short spa therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa therapy, exercise and educational therapyAlso: multidisciplinary programDuring 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 | Spa therapy, exercise and educational therapy |
| Usual careInformation, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book | Other | Usual care and counselling (Back book) |
Primary outcome
Frequency of return to work
Time frame: 1 year
Frequency of return to work 1 year after the inclusion date
5 secondary outcomes
Pain
Time frame: Every 2 weeks during 1 year
Function
Time frame: 1 year
Quality of life
Time frame: 1 year
TWIST
Time frame: 1 year
Sick leave
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Background: PubMed 10470716Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
- Background: PubMed 15246122Boutron 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.
- Background: PubMed 17311468Boutron 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.
- Background: PubMed 18283207Boutron 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.
- Background: PubMed 17684553Coudeyre 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.
- Background: PubMed 19734131Forestier 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.
- Background: PubMed 10910790Druss 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.
- Background: PubMed 11145817Hansson 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.
- Background: PubMed 17364769Magnussen 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.
- Background: PubMed 19808766Costa 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.
- Background: PubMed 9117181Nguyen 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.
- Background: PubMed 12784408Quilty 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge POIRAUDEAU, MD PhD principal investigator
Cochin Hospital and Descartes University, INSERM
Emmanuel COUDEYRE, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
Arnaud DUPEYRON, MD, PhD principal investigator
Groupe Hospitalo-Universitaire Carémeau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy, exercise and educational therapy in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of return to work (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648738, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.