Chronic Low Back PainNCT02894125
Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.
An observational study of Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Low back pain is considered to be chronic if it has been present for longer than three months. This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- SPA Therapy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Aug 2016
- Phase
- Observational
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: old subjects with a chronic low back pain
Who may be able to join
- - Both sexes
- 60-80 years old
- Realizing a SPA Therapy of 3 weeks.
- Presenting a mechanical pain of the rachis lumbar vertebra > 3 months
- Possible irradiation up to the knee (cruralgia / sciatalgie truncated)
- Cooperation and understanding allowing to conform in a strict way to the conditions planned by the study
- Acceptance to participate in the study (non-opposition)
Who cannot join
- - < 60-year-old patients or > 80 years
- Inflammatory, tumoral, traumatic or infectious rheumatism
- Surgery of the back
- SPA Therapy dating less than 6 months
- Evolutionary slipped disc
- Disorders(confusions) of the concentration or the compression of the written or oral French language making impossible the realization of the study
- The pain estimated by the digital scale = 0 in the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Low back pain is considered to be chronic if it has been present for longer than three months.
This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.
Read more
The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.
The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to "Neyrac-les-Bains".
Read the detailed description
Realization of the protocol :
- Selection of the patients (realized during the consultation of programming in the beginning of the SPA Therapy). They are 2 thermal doctors of "Neyrac-les-Bains" (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of SPA Therapy.
- They will put back to the patients the Inform Consent Form, the Form of non-opposition and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal to help them to fill the questionnaire if need.
An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled questionnaires (J0 and J21).
Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or modification of the care provided.
Feedback :
Assessments conducted by the using of self - questionnaires:
- Delivered in the issue of the visit of inclusion and at the end of the Spa Therapy ;
- Sent by mail at 3 and 6 months
The expectations and fears will be evaluated by means of individual interview or focus groups. To avoid the biases bound to the questionnaire, the patients questioned in qualitative are different from patients receiving the questionnaire (not over the same period of SPA Therapy).
- Conditions
- Chronic Low Back Pain
- Being tested
- SPA Therapy
- Keywords
- Chronic Low Back Pain, Old subject, SPA Therapy, Pain, Function, Expectations, Fears
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPA TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| old subject | Not described Receives: Other: SPA Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain's estimation by the digital scale
Measured: at 3 months
Secondary outcomes (5)
functional incapacity by means of the questionnaire "Oswestry Disability index"
Measured: at 0 days, 21 days, 3 months and 6 months
personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"
Measured: at 0 day , 21 days, 3 months, 6 months
fears and the faiths with the FABQ (physical dimension only)
Measured: at 0 day , 21 days, 3 months, 6 months
consumption of analgesic estimated by a standardized collection
Measured: at 21 days, 3 months, 6 months
expectations and fears by means of individual interview or focus groups by means of the quantitative questionnaire for qualitative analysis.
Measured: at 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte ESCHALIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894125
- Sponsor's protocol ID
- CHU-275
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
Publications
Rudy TE, Weiner DK, Lieber SJ, Slaboda J, Boston RJ. The impact of chronic low back pain on older adults: a comparative study of patients and controls. Pain. 2007 Oct;131(3):293-301. doi: 10.1016/j.pain.2007.01.012. Epub 2007 Feb 20.
PubMed 17317008Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
PubMed 19734131Pittler MH, Karagulle MZ, Karagulle M, Ernst E. Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials. Rheumatology (Oxford). 2006 Jul;45(7):880-4. doi: 10.1093/rheumatology/kel018. Epub 2006 Jan 31.
PubMed 16449365Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
PubMed 16777886Loney PL, Stratford PW. The prevalence of low back pain in adults: a methodological review of the literature. Phys Ther. 1999 Apr;79(4):384-96.
PubMed 10201544Raud B, Lanhers C, Crouzet C, Eschalier B, Bougeard F, Goldstein A, Pereira B, Coudeyre E. Identification of Responders to Balneotherapy among Adults over 60 Years of Age with Chronic Low Back Pain: A Pilot Study with Trajectory Model Analysis. Int J Environ Res Public Health. 2022 Nov 8;19(22):14669. doi: 10.3390/ijerph192214669.
PubMed 36429387
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT02894125
- Acronym / sponsor ID
- CHU-275
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Old subject, SPA Therapy, Pain, Function, Expectations, Fears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
Low back pain is considered to be chronic if it has been present for longer than three months.
This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.
The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.
The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to "Neyrac-les-Bains".
Detailed description
Realization of the protocol :
- Selection of the patients (realized during the consultation of programming in the beginning of the SPA Therapy). They are 2 thermal doctors of "Neyrac-les-Bains" (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of SPA Therapy.
- They will put back to the patients the Inform Consent Form, the Form of non-opposition and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal to help them to fill the questionnaire if need.
An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled questionnaires (J0 and J21).
Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or modification of the care provided.
Feedback :
Assessments conducted by the using of self - questionnaires:
- Delivered in the issue of the visit of inclusion and at the end of the Spa Therapy ;
- Sent by mail at 3 and 6 months
The expectations and fears will be evaluated by means of individual interview or focus groups. To avoid the biases bound to the questionnaire, the patients questioned in qualitative are different from patients receiving the questionnaire (not over the same period of SPA Therapy).
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| old subject | – | Other: SPA Therapy |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- old subjects with a chronic low back pain
Key inclusion criteria (7 listed)
- - Both sexes
- 60-80 years old
- Realizing a SPA Therapy of 3 weeks.
- Presenting a mechanical pain of the rachis lumbar vertebra > 3 months
- Possible irradiation up to the knee (cruralgia / sciatalgie truncated)
Key exclusion criteria (7 listed)
- - < 60-year-old patients or > 80 years
- Inflammatory, tumoral, traumatic or infectious rheumatism
- Surgery of the back
- SPA Therapy dating less than 6 months
- Evolutionary slipped disc
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 |
|---|---|---|
| SPA Therapy | Other | old subject |
Primary outcome
Pain's estimation by the digital scale
Time frame: at 3 months
5 secondary outcomes
functional incapacity by means of the questionnaire "Oswestry Disability index"
Time frame: at 0 days, 21 days, 3 months and 6 months
personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"
Time frame: at 0 day , 21 days, 3 months, 6 months
fears and the faiths with the FABQ (physical dimension only)
Time frame: at 0 day , 21 days, 3 months, 6 months
consumption of analgesic estimated by a standardized collection
Time frame: at 21 days, 3 months, 6 months
expectations and fears by means of individual interview or focus groups by means of the quantitative questionnaire for qualitative analysis.
Time frame: at 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Background: PubMed 17317008Rudy TE, Weiner DK, Lieber SJ, Slaboda J, Boston RJ. The impact of chronic low back pain on older adults: a comparative study of patients and controls. Pain. 2007 Oct;131(3):293-301. doi: 10.1016/j.pain.2007.01.012. Epub 2007 Feb 20.
- Background: PubMed 19734131Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
- Background: PubMed 16449365Pittler MH, Karagulle MZ, Karagulle M, Ernst E. Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials. Rheumatology (Oxford). 2006 Jul;45(7):880-4. doi: 10.1093/rheumatology/kel018. Epub 2006 Jan 31.
- Background: PubMed 16777886Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
- Background: PubMed 10201544Loney PL, Stratford PW. The prevalence of low back pain in adults: a methodological review of the literature. Phys Ther. 1999 Apr;79(4):384-96.
- Derived from this study: PubMed 36429387Raud B, Lanhers C, Crouzet C, Eschalier B, Bougeard F, Goldstein A, Pereira B, Coudeyre E. Identification of Responders to Balneotherapy among Adults over 60 Years of Age with Chronic Low Back Pain: A Pilot Study with Trajectory Model Analysis. Int J Environ Res Public Health. 2022 Nov 8;19(22):14669. doi: 10.3390/ijerph192214669.
Related trials for Chronic Low Back Pain
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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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.
Bénédicte ESCHALIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 12 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain's estimation by the digital scale (time frame: at 3 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 NCT02894125, which also lists 6 linked publications.
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 12 Sep 2016.