Non-pharmacological Treatment for Chronic Back Pain
LOMBATHERM
1 other identifier
interventional
358
1 country
1
Brief Summary
The working hypothesis is that spa therapy in addition to usual care including home exercises (UCHE) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. It follows that health resource consumption and linked costs should also be reduced. The primary objective of this study is therefore to compare the therapeutic effect of UCHE alone versus spa therapy in addition to UCHE for chronic low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jun 2019
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedStudy Start
First participant enrolled
June 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedNovember 7, 2019
June 1, 2019
2.5 years
March 12, 2019
November 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain, defined by an improvement of at least 30%; cases where patients demonstrate a 30% improvement in VAS scores for pain but nevertheless require hospitalisation for back pain during the study follow-up period will be considered as treatment failures (absence of clinically relevant change).
6 months
Secondary Outcomes (46)
Huskinsson's VAS for pain.
Baseline (day 0)
Huskinsson's VAS for pain.
1 month
Huskinsson's VAS for pain.
6 months
Huskinsson's VAS for pain.
12 months
The EIFEL scale
Baseline (day 0)
- +41 more secondary outcomes
Study Arms (2)
Control group
ACTIVE COMPARATORThe control group will perform home exercises alone
Spa group
EXPERIMENTALThe spa group will be proposed an additional spa treatment
Interventions
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.
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
You may qualify if:
- Adult patient presenting with chronic low back pain: usual pain of the lumbar region lasting for more than 3 months. This pain may radiate to the buttocks, iliac crest, and does not go past the knee.
- 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 \[national health insurance\]
You may not qualify if:
- Patients with secondary low back pain
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de recherche rhumatologique et thermal
Aix-les-Bains, 73100, France
Related Publications (1)
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.
PMID: 32393320DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
April 10, 2019
Study Start
June 15, 2019
Primary Completion
December 15, 2021
Study Completion
June 15, 2022
Last Updated
November 7, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- As close to "real time" as possible, the following supporting information will be made public: * Study Protocol * Statistical Analysis Plan * Participant Information materials * Analytic code The study protocol will be submitted to the journal "Trials" for publication. The remaining documents will either be published or posted / registered on osf.io/clinicaltrials.gov. The clinicaltrials.gov registration will contain a link that points to the appropriate osf.io page. Requests for individual datasets can be made anytime following full publication of results.
- Access Criteria
- Due to French law there are restrictions on publicly sharing the data of this study. Data requests may be submitted to the AFRETH and must be approved by the French data protection authority, la Commission Nationale de l'Informatique et des Libertés. Data requests may be sent to AFRETH. French law requires that everyone who wishes to access cohorts data or clinical study data on humans must ask the French data protection authority, la Commission Nationale de l'Informatique et des Libertés (CNIL), for permission. For further information, please see: https://www.cnil.fr/. "
The general goal is to, in as much as possible, make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Due to conditions imposed by French law, data will be made available to the public upon request to the AFRETH scientific committee (Association Française pour la Recherche Thermale, 1 rue Cels 75014 Paris, France; http://www.afreth.org).