Low Back PainLOMBATHERMNCT03910023
Non-pharmacological Treatment for Chronic Back Pain
A study testing Spa therapy in people with Low Back Pain, run by Association Francaise pour la Recherche Thermale at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2019to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de recherche rhumatologique et thermal
Aix-les-Bains, 73100
Romain FORESTIER, Dr, 0479351487, romain.forestier@wanadoo.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Usual care comporting a home-exercise program (UCHE), Spa therapy
- Keywords
- Low back pain, Crenobalneotherapy, Spa therapy, Mud application, Water exercises, Underwater massages
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care comporting a home-exercise program (UCHE)Other
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will perform home exercises alone Receives: Other: Usual care comporting a home-exercise program (UCHE) |
| Spa group | Experimental | The spa group will be proposed an additional spa treatment Receives: Other: Usual care comporting a home-exercise program (UCHE); Other: Spa therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (46)
Huskinsson's VAS for pain.
Measured: Baseline (day 0)
Huskinsson's VAS for pain.
Measured: 1 month
Huskinsson's VAS for pain.
Measured: 6 months
Huskinsson's VAS for pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Measured: 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)
Measured: 1 month
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Measured: 6 months
Daily drug consumption over the past 72 hours: Corticosteroids
Daily drug consumption over the past 72 hours: Corticosteroids (in mg equivalent prednisone)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Number of infiltrations
Measured: 12 months
Estimated per-patient cost for one year of care
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start15 Jun 2019
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910023
- Sponsor's protocol ID
- 2018-A02801-54
- Acronym
- LOMBATHERM
- Status last verified
- Jun 2019
- First submitted
- 12 Mar 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
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.
PubMed 32393320
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT03910023
- Acronym / sponsor ID
- LOMBATHERM / 2018-A02801-54
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Crenobalneotherapy, Spa therapy, Mud application, Water exercises, Underwater massages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Usual care comporting a home-exercise program (UCHE)The control group will perform home exercises alone |
| Spa group | Experimental | Other: Usual care comporting a home-exercise program (UCHE), Other: Spa therapyThe spa group will be proposed an additional spa treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control group, Spa group |
| Spa therapythe 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. | Other | Spa group |
Primary outcome
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain
Time frame: 6 months
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).
46 secondary outcomes
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
Time frame: Baseline (day 0)
The EIFEL scale
Time frame: 1 month
The EIFEL scale
Time frame: 6 months
The EIFEL scale
Time frame: 12 months
The Fear Avoidance and Belief Questionnaire (FABQ)
Time frame: Baseline (day 0)
The Fear Avoidance and Belief Questionnaire (FABQ)
Time frame: 1 month
The Fear Avoidance and Belief Questionnaire (FABQ)
Time frame: 6 months
The Fear Avoidance and Belief Questionnaire (FABQ)
Time frame: 12 months
The EQ-5D-5L questionnaire
Time frame: Baseline (day 0)
The EQ-5D-5L questionnaire
Time frame: 1 month
The EQ-5D-5L questionnaire
Time frame: 6 months
The EQ-5D-5L questionnaire
Time frame: 12 months
Patient Acceptable Symptom State (PASS)
Time frame: Baseline (day 0)
Patient Acceptable Symptom State (PASS)
Time frame: 1 month
Patient Acceptable Symptom State (PASS)
Time frame: 6 months
Patient Acceptable Symptom State (PASS)
Time frame: 12 months
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)
Time frame: 1 month
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)
Time frame: 12 months
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)
Time frame: 1 month
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)
Time frame: 12 months
Daily drug consumption over the past 72 hours: Analgesics
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: Analgesics
Time frame: 1 month
Daily drug consumption over the past 72 hours: Analgesics
Time frame: 6 months
Daily drug consumption over the past 72 hours: Analgesics
Time frame: 12 months
Daily drug consumption over the past 72 hours: NSAIDs
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: NSAIDs
Time frame: 1 month
Daily drug consumption over the past 72 hours: NSAIDs
Time frame: 6 months
Daily drug consumption over the past 72 hours: NSAIDs
Time frame: 12 months
Daily drug consumption over the past 72 hours: Corticosteroids
Time frame: Baseline (day 0)
Daily drug consumption over the past 72 hours: Corticosteroids
Time frame: 1 month
Daily drug consumption over the past 72 hours: Corticosteroids
Time frame: 6 months
Daily drug consumption over the past 72 hours: Corticosteroids
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Derived from this study: PubMed 32393320Forestier 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.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy in people with Low Back Pain, run by Association Francaise pour la Recherche Thermale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain FORESTIER, MD (00334 79 35 14 87, romain.forestier@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.