Non-pharmacological Treatment for Chronic Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Usual care comporting a home-exercise program (UCHE)Other: Spa therapy
- Registration Number
- NCT03910023
- Lead Sponsor
- Association Francaise pour la Recherche Thermale
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 358
- 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]
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spa group Spa therapy The spa group will be proposed an additional spa treatment Spa group Usual care comporting a home-exercise program (UCHE) The spa group will be proposed an additional spa treatment Control group Usual care comporting a home-exercise program (UCHE) The control group will perform home exercises alone
- Primary Outcome Measures
Name Time Method Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain 6 months 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).
- Secondary Outcome Measures
Name Time Method Huskinsson's VAS for pain. 12 months The Fear Avoidance and Belief Questionnaire (FABQ) 12 months The Fear Avoidance and Belief Questionnaire (FABQ) assess inappropriate fears and beliefs concerning back pain; the validated French version will be used.
Patient Acceptable Symptom State (PASS) 12 months Patient Acceptable Symptom State (PASS): Yes/no response to the following question: "If you take into account all the activities you have in your daily life, the importance of your pain and your disability, do you consider your condition as satisfactory?"
Overall opinion of the patient on his/her state of health (5-point Likert scale) 12 months Overall opinion of the patient on his/her state of health (5-point Likert scale)
Daily drug consumption over the past 72 hours: Analgesics 12 months Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Estimated per-patient cost for one year of care 12 months The EIFEL scale 12 months The EIFEL scale: the validated French version of a disability rating scale by Rolland and Morris. This 24-question scale (with scores ranging from 0 (no impact) to 24 (maximum impact) quantifies the impact of low back pain on daily life.
Daily drug consumption over the past 72 hours: Corticosteroids 12 months Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: 12 months Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale) 12 months Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
The EQ-5D-5L questionnaire 12 months The EQ-5D-5L questionnaire will be used to track changes in quality of life. This self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Daily drug consumption over the past 72 hours: NSAIDs 12 months Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Number of infiltrations 12 months
Trial Locations
- Locations (1)
Centre de recherche rhumatologique et thermal
🇫🇷Aix-Les-Bains, France