Clinical trial NCT03910023: Non-pharmacological Treatment for Chronic Back Pain
Official title: Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Crenobalneotherapy
Spa therapy
Mud application
Water exercises
Underwater massages
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective, evaluator-blinded, multi-centre, 2-parallel-arm, Zelen randomized (1:1), controlled trial, UCHE alone will be compared to spa therapy in addition to UCHE for the treatment of chronic low back pain.
Primary purpose: TREATMENT

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.

Detailed description: Secondarily, the study will also (i) evaluate the therapeutic effects specific to each spa-centre, (ii) specifically describe effects among subjects who are currently engaged in a professional activity, (iii) evaluate treatment tolerance as well as (iv) per-patient health resource use and associated costs.

Eligibility criteria: Inclusion Criteria:

* 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 \[national health insurance\]

Exclusion Criteria:

* 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

Primary outcomes:
measure: Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain
timeFrame: 6 months
Secondary outcomes:
measure: Huskinsson's VAS for pain.
timeFrame: Baseline (day 0)
measure: Huskinsson's VAS for pain.
timeFrame: 1 month
measure: Huskinsson's VAS for pain.
timeFrame: 6 months
measure: Huskinsson's VAS for pain.
timeFrame: 12 months
measure: The EIFEL scale
timeFrame: Baseline (day 0)
measure: The EIFEL scale
timeFrame: 1 month
measure: The EIFEL scale
timeFrame: 6 months
measure: The EIFEL scale
timeFrame: 12 months
measure: The Fear Avoidance and Belief Questionnaire (FABQ)
timeFrame: Baseline (day 0)
measure: The Fear Avoidance and Belief Questionnaire (FABQ)
timeFrame: 1 month
measure: The Fear Avoidance and Belief Questionnaire (FABQ)
timeFrame: 6 months
measure: The Fear Avoidance and Belief Questionnaire (FABQ)
timeFrame: 12 months
measure: The EQ-5D-5L questionnaire
timeFrame: Baseline (day 0)
measure: The EQ-5D-5L questionnaire
timeFrame: 1 month
measure: The EQ-5D-5L questionnaire
timeFrame: 6 months
measure: The EQ-5D-5L questionnaire
timeFrame: 12 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Baseline (day 0)
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 1 month
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 12 months
measure: Overall opinion of the patient on his/her state of health (5-point Likert scale)
timeFrame: Baseline (day 0)
measure: Overall opinion of the patient on his/her state of health (5-point Likert scale)
timeFrame: 1 month
measure: Overall opinion of the patient on his/her state of health (5-point Likert scale)
timeFrame: 6 months
measure: Overall opinion of the patient on his/her state of health (5-point Likert scale)
timeFrame: 12 months
measure: Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
timeFrame: Baseline (day 0)
measure: Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
timeFrame: 1 month
measure: Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
timeFrame: 6 months
measure: Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
timeFrame: 12 months
measure: Daily drug consumption over the past 72 hours: Analgesics
timeFrame: Baseline (day 0)
measure: Daily drug consumption over the past 72 hours: Analgesics
timeFrame: 1 month
measure: Daily drug consumption over the past 72 hours: Analgesics
timeFrame: 6 months
measure: Daily drug consumption over the past 72 hours: Analgesics
timeFrame: 12 months
measure: Daily drug consumption over the past 72 hours: NSAIDs
timeFrame: Baseline (day 0)
measure: Daily drug consumption over the past 72 hours: NSAIDs
timeFrame: 1 month
measure: Daily drug consumption over the past 72 hours: NSAIDs
timeFrame: 6 months
measure: Daily drug consumption over the past 72 hours: NSAIDs
timeFrame: 12 months
measure: Daily drug consumption over the past 72 hours: Corticosteroids
timeFrame: Baseline (day 0)
measure: Daily drug consumption over the past 72 hours: Corticosteroids
timeFrame: 1 month
measure: Daily drug consumption over the past 72 hours: Corticosteroids
timeFrame: 6 months
measure: Daily drug consumption over the past 72 hours: Corticosteroids
timeFrame: 12 months
measure: Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
timeFrame: Baseline (day 0)
measure: Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
timeFrame: 1 month
measure: Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
timeFrame: 6 months
measure: Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
timeFrame: 12 months
measure: Number of infiltrations
timeFrame: 12 months
measure: Estimated per-patient cost for one year of care
timeFrame: 12 months
Other outcomes:
Locations:
city: Aix-Les-Bains
country: France
facility: Centre de recherche rhumatologique et thermal
Study officials:
References:
citation: 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.