An interventional study of Usual care comporting a home-exercise program (UCHE) and Spa therapy in Low Back Pain, sponsored by Association Francaise pour la Recherche Thermale. Status unknown at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-07.
Sponsored by Association Francaise pour la Recherche Thermale · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 358 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Association Francaise pour la Recherche Thermale is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
The control group will perform home exercises alone
Other: Usual care comporting a home-exercise program (UCHE)
The spa group will be proposed an additional spa treatment
Other: Usual care comporting a home-exercise program (UCHE) · Other: Spa therapy
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.
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).
Time frame: 6 months
Huskinsson's VAS for pain.
Time frame: Baseline (day 0)
Huskinsson's VAS for pain.
Time frame: 1 month
Huskinsson's VAS for pain.
Time frame: 6 months
Huskinsson's VAS for pain.
Time frame: 12 months
The EIFEL scale
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.
Time frame: Baseline (day 0)
The EIFEL scale
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.
Time frame: 1 month
The EIFEL scale
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.
Time frame: 6 months
The EIFEL scale
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.
Time frame: 12 months
The Fear Avoidance and Belief Questionnaire (FABQ)
The Fear Avoidance and Belief Questionnaire (FABQ) assess inappropriate fears and beliefs concerning back pain; the validated French version will be used.
Time frame: Baseline (day 0)
The Fear Avoidance and Belief Questionnaire (FABQ)
The Fear Avoidance and Belief Questionnaire (FABQ) assess inappropriate fears and beliefs concerning back pain; the validated French version will be used.
Time frame: 1 month
The Fear Avoidance and Belief Questionnaire (FABQ)
The Fear Avoidance and Belief Questionnaire (FABQ) assess inappropriate fears and beliefs concerning back pain; the validated French version will be used.
Time frame: 6 months
The Fear Avoidance and Belief Questionnaire (FABQ)
The Fear Avoidance and Belief Questionnaire (FABQ) assess inappropriate fears and beliefs concerning back pain; the validated French version will be used.
Time frame: 12 months
The EQ-5D-5L questionnaire
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.
Time frame: Baseline (day 0)
The EQ-5D-5L questionnaire
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.
Time frame: 1 month
The EQ-5D-5L questionnaire
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.
Time frame: 6 months
The EQ-5D-5L questionnaire
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.
Time frame: 12 months
Patient Acceptable Symptom State (PASS)
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?"
Time frame: Baseline (day 0)
Patient Acceptable Symptom State (PASS)
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?"
Time frame: 1 month
Patient Acceptable Symptom State (PASS)
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?"
Time frame: 6 months
Patient Acceptable Symptom State (PASS)
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?"
Time frame: 12 months
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time frame: Baseline (day 0)
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time frame: 1 month
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time frame: 6 months
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time frame: 12 months
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time frame: Baseline (day 0)
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time frame: 1 month
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time frame: 6 months
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time frame: 12 months
Daily drug consumption over the past 72 hours: Analgesics
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: Analgesics
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time frame: 1 month
Daily drug consumption over the past 72 hours: Analgesics
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time frame: 6 months
Daily drug consumption over the past 72 hours: Analgesics
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time frame: 12 months
Daily drug consumption over the past 72 hours: NSAIDs
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: NSAIDs
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time frame: 1 month
Daily drug consumption over the past 72 hours: NSAIDs
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time frame: 6 months
Daily drug consumption over the past 72 hours: NSAIDs
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time frame: 12 months
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time frame: 1 month
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time frame: 6 months
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time frame: 12 months
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time frame: 1 month
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time frame: 6 months
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time frame: 12 months
Number of infiltrations
Time frame: 12 months
Estimated per-patient cost for one year of care
Time frame: 12 months
Plan to share: Yes — 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).
Supporting information: Study protocol, Sap, Icf, Analytic code
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Association Francaise pour la Recherche Thermale