Non-pharmacological Treatment for Chronic Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Usual care comporting a home-exercise program (UCHE)
* Other: Spa therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The control group will perform home exercises alone | Other: Usual care comporting a home-exercise program (UCHE)<br>* 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.<br>|
| Experimental: Spa group<br>The spa group will be proposed an additional spa treatment | Other: Usual care comporting a home-exercise program (UCHE)<br>* 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.<br>Other: Spa therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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? | 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? | 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? | 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? | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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). | 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). | 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). | 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). | 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) | 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) | 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) | 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) | 12 months | 
| Daily drug consumption over the past 72 hours: Corticosteroids | Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone) | 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) | 1 month | 
| Daily drug consumption over the past 72 hours: Corticosteroids | Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone) | 6 months | 
| Daily drug consumption over the past 72 hours: Corticosteroids | Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone) | 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 | 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 | 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 | 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 | 12 months | 
| Number of infiltrations |  | 12 months | 
| Estimated per-patient cost for one year of care |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Crenobalneotherapy, Spa therapy, Mud application, Water exercises, Underwater massages