Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
358 participants
INTERVENTIONAL
2019-06-15
2022-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
The control group will perform home exercises alone
Usual care comporting a home-exercise program (UCHE)
The UCHE intervention will correspond to current practice (including the continuation of previous treatments, if applicable) as decided by the attending physician. The patient will also be provided with a practical guide on how to manage back pain (the "back book"), including a recommended home exercise program.
Spa group
The spa group will be proposed an additional spa treatment
Usual care comporting a home-exercise program (UCHE)
The UCHE intervention will correspond to current practice (including the continuation of previous treatments, if applicable) as decided by the attending physician. The patient will also be provided with a practical guide on how to manage back pain (the "back book"), including a recommended home exercise program.
Spa therapy
the spa-therapy intervention consists of 18 consecutive days of spa-therapy (excepting Sundays), that must occur with 60 days of randomisation. The latter will combine mineral water with physical and hydrotherapeutic treatments, including massages, heat and water exercises.
Interventions
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Usual care comporting a home-exercise program (UCHE)
The UCHE intervention will correspond to current practice (including the continuation of previous treatments, if applicable) as decided by the attending physician. The patient will also be provided with a practical guide on how to manage back pain (the "back book"), including a recommended home exercise program.
Spa therapy
the spa-therapy intervention consists of 18 consecutive days of spa-therapy (excepting Sundays), that must occur with 60 days of randomisation. The latter will combine mineral water with physical and hydrotherapeutic treatments, including massages, heat and water exercises.
Eligibility Criteria
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Inclusion Criteria
* Patient presenting with a current pain intensity on a visual analogue scale (VAS) \> or = 40 mm.
* The patient has signed the informed consent
* The patient is a beneficiary of a social security programme \[national health insurance\]
Exclusion Criteria
* Patients with severe depression, psychosis
* Patients who have already had a spa treatment in the previous 6 months
* Patients with a contraindication for spa treatment
* Patients with a professional activity related to hydrotherapy (to avoid any conflict of interest)
* Patients with sciatic pain beyond the knee (sciatica being a non-indication for spa treatment)
* Other treatments that may interact according to the judgment of the investigator
* Patients who live more than 30 km away from the spa
18 Years
80 Years
ALL
No
Sponsors
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Association Francaise pour la Recherche Thermale
OTHER
Responsible Party
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Locations
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Centre de recherche rhumatologique et thermal
Aix-les-Bains, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Forestier R, Suehs C, Francon A, Marty M, Genevay S, Sellam J, Chauveton C, Erol Forestier FB, Molinari N. Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial. Trials. 2020 May 11;21(1):392. doi: 10.1186/s13063-020-04271-9.
Other Identifiers
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2018-A02801-54
Identifier Type: -
Identifier Source: org_study_id
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