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.

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: SPA Therapy

• Registration Number: NCT02894125
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 :

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).

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
old subject	SPA Therapy	-

Primary Outcome Measures

Name	Time	Method
Pain's estimation by the digital scale	at 3 months

Secondary Outcome Measures

Name	Time	Method
consumption of analgesic estimated by a standardized collection	at 21 days, 3 months, 6 months
fears and the faiths with the FABQ (physical dimension only)	at 0 day , 21 days, 3 months, 6 months
functional incapacity by means of the questionnaire "Oswestry Disability index"	at 0 days, 21 days, 3 months and 6 months
personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"	at 0 day , 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.	at 0 day

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France