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.

September 9, 2016 updated by: University Hospital, Clermont-Ferrand

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

old subjects with a chronic low back pain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
old subject
Other: SPA Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain's estimation by the digital scale
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
functional incapacity by means of the questionnaire "Oswestry Disability index"
Time Frame: at 0 days, 21 days, 3 months and 6 months
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
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
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
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
at 0 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Bénédicte ESCHALIER, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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