Non-pharmacological Treatment for Chronic Back Pain (LOMBATHERM)

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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Usual care comporting a home-exercise program (UCHE); Other: Spa therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-Les-Bains, France, 73100
    • Recruiting
    • Centre de Recherche Rhumatologique et Thermal
    • Contact: Romain FORESTIER, Dr; Phone Number: 0479351487; Email: romain.forestier@wanadoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; The control group will perform home exercises alone	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.
EXPERIMENTAL: Spa group; The spa group will be proposed an additional spa treatment	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.; Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Association Francaise pour la Recherche Thermale

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2019
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): June 15, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Low back pain; Spa therapy; Crenobalneotherapy; Mud application; Water exercises; Underwater massages
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2018-A02801-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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).

IPD Sharing Time Frame

As close to "real time" as possible, the following supporting information will be made public:

• Study Protocol
• Statistical Analysis Plan
• Participant Information materials
• Analytic code

The study protocol will be submitted to the journal "Trials" for publication.

The remaining documents will either be published or posted / registered on osf.io/clinicaltrials.gov. The clinicaltrials.gov registration will contain a link that points to the appropriate osf.io page.

Requests for individual datasets can be made anytime following full publication of results.

• IPD Sharing Access Criteria: Due to French law there are restrictions on publicly sharing the data of this study. Data requests may be submitted to the AFRETH and must be approved by the French data protection authority, la Commission Nationale de l'Informatique et des Libertés. Data requests may be sent to AFRETH. French law requires that everyone who wishes to access cohorts data or clinical study data on humans must ask the French data protection authority, la Commission Nationale de l'Informatique et des Libertés (CNIL), for permission. For further information, please see: https://www.cnil.fr/. "
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No