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.
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Locations
France
Study Type
Observational
Intervention
SPA Therapy
Sponsored by
About this trial
This is an observational trial for Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Old subject, SPA Therapy, Pain, Function, Expectations, Fears
Eligibility Criteria
Inclusion Criteria:
- - 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)
Exclusion Criteria:
- - < 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
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Arm Label
old subject
Arm Description
Outcomes
Primary Outcome Measures
Pain's estimation by the digital scale
Secondary Outcome Measures
functional incapacity by means of the questionnaire "Oswestry Disability index"
personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"
fears and the faiths with the FABQ (physical dimension only)
consumption of analgesic estimated by a standardized collection
expectations and fears by means of individual interview or focus groups by means of the quantitative questionnaire for qualitative analysis.
Full Information
NCT ID
NCT02894125
First Posted
September 5, 2016
Last Updated
September 9, 2016
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02894125
Brief 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.
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.
Study Type
Observational
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic Low Back Pain, Old subject, SPA Therapy, Pain, Function, Expectations, Fears
7. Study Design
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
old subject
Intervention Type
Other
Intervention Name(s)
SPA Therapy
Primary Outcome Measure Information:
Title
Pain's estimation by the digital scale
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
functional incapacity by means of the questionnaire "Oswestry Disability index"
Time Frame
at 0 days, 21 days, 3 months and 6 months
Title
personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"
Time Frame
at 0 day , 21 days, 3 months, 6 months
Title
fears and the faiths with the FABQ (physical dimension only)
Time Frame
at 0 day , 21 days, 3 months, 6 months
Title
consumption of analgesic estimated by a standardized collection
Time Frame
at 21 days, 3 months, 6 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- < 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
Study Population Description
old subjects with a chronic low back pain
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bénédicte ESCHALIER
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17317008
Citation
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.
Results Reference
background
PubMed Identifier
19734131
Citation
Forestier 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.
Results Reference
background
PubMed Identifier
16449365
Citation
Pittler 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.
Results Reference
background
PubMed Identifier
16777886
Citation
Koes 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.
Results Reference
background
PubMed Identifier
10201544
Citation
Loney 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.
Results Reference
background
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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.
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