Non-pharmacological Treatment for Chronic Back Pain

Low Back Pain Clinical Trial

— LOMBATHERM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910023
• Other study ID #: 2018-A02801-54
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: June 15, 2022

Study information

• Verified date: June 2019
• Source: Association Francaise pour la Recherche Thermale
• Contact: Romain FORESTIER, MD
• Phone: 00334 79 35 14 87
• Email: romain.forestier[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: June 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Usual care comporting a home-exercise program (UCHE)
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.
• Spa therapy
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.

Locations

Country	Name	City	State
France	Centre de recherche rhumatologique et thermal	Aix-Les-Bains

Sponsors (1)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Huskinsson's VAS for pain.		Baseline (day 0)
Secondary	Huskinsson's VAS for pain.		1 month
Secondary	Huskinsson's VAS for pain.		6 months
Secondary	Huskinsson's VAS for pain.		12 months
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Daily drug consumption over the past 72 hours: Corticosteroids	Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)	1 month
Secondary	Daily drug consumption over the past 72 hours: Corticosteroids	Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)	6 months
Secondary	Daily drug consumption over the past 72 hours: Corticosteroids	Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)	12 months
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of infiltrations		12 months
Secondary	Estimated per-patient cost for one year of care		12 months