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Non-pharmacological Treatment for Chronic Back Pain (LOMBATHERM)

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual care comporting a home-exercise program (UCHE)
Spa therapy
Sponsored by
Association Francaise pour la Recherche Thermale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Crenobalneotherapy, Spa therapy, Mud application, Water exercises, Underwater massages

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherche rhumatologique et thermalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Spa group

Arm Description

The control group will perform home exercises alone

The spa group will be proposed an additional spa treatment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Huskinsson's VAS for pain.
Huskinsson's VAS for pain.
Huskinsson's VAS for pain.
Huskinsson's VAS for pain.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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?"
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?"
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?"
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?"
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)
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)
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)
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)
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)
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)
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)
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)
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).
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).
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).
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).
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)
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)
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)
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)
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
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
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
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
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
Number of infiltrations
Estimated per-patient cost for one year of care

Full Information

First Posted
March 12, 2019
Last Updated
November 5, 2019
Sponsor
Association Francaise pour la Recherche Thermale
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1. Study Identification

Unique Protocol Identification Number
NCT03910023
Brief Title
Non-pharmacological Treatment for Chronic Back Pain
Acronym
LOMBATHERM
Official Title
Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Crenobalneotherapy, Spa therapy, Mud application, Water exercises, Underwater massages

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will perform home exercises alone
Arm Title
Spa group
Arm Type
Experimental
Arm Description
The spa group will be proposed an additional spa treatment
Intervention Type
Other
Intervention Name(s)
Usual care comporting a home-exercise program (UCHE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Spa therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain
Description
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
Secondary Outcome Measure Information:
Title
Huskinsson's VAS for pain.
Time Frame
Baseline (day 0)
Title
Huskinsson's VAS for pain.
Time Frame
1 month
Title
Huskinsson's VAS for pain.
Time Frame
6 months
Title
Huskinsson's VAS for pain.
Time Frame
12 months
Title
The EIFEL scale
Description
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)
Title
The EIFEL scale
Description
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
Title
The EIFEL scale
Description
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
Title
The EIFEL scale
Description
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
Title
The Fear Avoidance and Belief Questionnaire (FABQ)
Description
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)
Title
The Fear Avoidance and Belief Questionnaire (FABQ)
Description
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
Title
The Fear Avoidance and Belief Questionnaire (FABQ)
Description
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
Title
The Fear Avoidance and Belief Questionnaire (FABQ)
Description
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
Title
The EQ-5D-5L questionnaire
Description
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)
Title
The EQ-5D-5L questionnaire
Description
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
Title
The EQ-5D-5L questionnaire
Description
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
Title
The EQ-5D-5L questionnaire
Description
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
Title
Patient Acceptable Symptom State (PASS)
Description
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)
Title
Patient Acceptable Symptom State (PASS)
Description
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
Title
Patient Acceptable Symptom State (PASS)
Description
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
Title
Patient Acceptable Symptom State (PASS)
Description
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
Title
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Description
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time Frame
Baseline (day 0)
Title
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Description
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time Frame
1 month
Title
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Description
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time Frame
6 months
Title
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Description
Overall opinion of the patient on his/her state of health (5-point Likert scale)
Time Frame
12 months
Title
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Description
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time Frame
Baseline (day 0)
Title
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Description
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time Frame
1 month
Title
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Description
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time Frame
6 months
Title
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Description
Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)
Time Frame
12 months
Title
Daily drug consumption over the past 72 hours: Analgesics
Description
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time Frame
Baseline (day 0)
Title
Daily drug consumption over the past 72 hours: Analgesics
Description
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time Frame
1 month
Title
Daily drug consumption over the past 72 hours: Analgesics
Description
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time Frame
6 months
Title
Daily drug consumption over the past 72 hours: Analgesics
Description
Daily drug consumption over the past 72 hours: Analgesics (in mg of paracetamol and morphine equivalents).
Time Frame
12 months
Title
Daily drug consumption over the past 72 hours: NSAIDs
Description
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)
Title
Daily drug consumption over the past 72 hours: NSAIDs
Description
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time Frame
1 month
Title
Daily drug consumption over the past 72 hours: NSAIDs
Description
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time Frame
6 months
Title
Daily drug consumption over the past 72 hours: NSAIDs
Description
Daily drug consumption over the past 72 hours: NSAIDs (reported in mg and as a percentage of the maximum dose)
Time Frame
12 months
Title
Daily drug consumption over the past 72 hours: Corticosteroids
Description
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time Frame
Baseline (day 0)
Title
Daily drug consumption over the past 72 hours: Corticosteroids
Description
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time Frame
1 month
Title
Daily drug consumption over the past 72 hours: Corticosteroids
Description
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time Frame
6 months
Title
Daily drug consumption over the past 72 hours: Corticosteroids
Description
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Time Frame
12 months
Title
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Description
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time Frame
Baseline (day 0)
Title
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Description
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time Frame
1 month
Title
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Description
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time Frame
6 months
Title
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:
Description
Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants: % of maximum dose
Time Frame
12 months
Title
Number of infiltrations
Time Frame
12 months
Title
Estimated per-patient cost for one year of care
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romain FORESTIER, MD
Phone
00334 79 35 14 87
Email
romain.forestier@wanadoo.fr
Facility Information:
Facility Name
Centre de recherche rhumatologique et thermal
City
Aix-Les-Bains
ZIP/Postal Code
73100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain FORESTIER, Dr
Phone
0479351487
Email
romain.forestier@wanadoo.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://osf.io/ahpwy/
Citations:
PubMed Identifier
32393320
Citation
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.
Results Reference
derived

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Non-pharmacological Treatment for Chronic Back Pain

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