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.

NCT ID: NCT02894125

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Realization of the protocol :

1. 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.
2. 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

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Chronic Low Back Pain

Study Groups

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old subject

SPA Therapy

Intervention Type OTHER

Interventions

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SPA Therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bénédicte ESCHALIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 17317008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19734131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16449365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16777886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10201544 (View on PubMed)

Raud 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.

Reference Type DERIVED
PMID: 36429387 (View on PubMed)

Other Identifiers

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CHU-275

Identifier Type: -

Identifier Source: org_study_id

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