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.

Chronic Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894125
• Other study ID #: CHU-275
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 9, 2016
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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. 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".

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• SPA Therapy

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (5)

Forestier R, Desfour H, Tessier JM, Françon 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. — View Citation

Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. Review. — View 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. Review. — View Citation

Pittler MH, Karagülle MZ, Karagülle 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. Epub 2006 Jan 31. Review. — View Citation

Rudy TE, Weiner DK, Lieber SJ, Slaboda J, Boston JR. The impact of chronic low back pain on older adults: a comparative study of patients and controls. Pain. 2007 Oct;131(3):293-301. Epub 2007 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain's estimation by the digital scale		at 3 months	Yes
Secondary	functional incapacity by means of the questionnaire "Oswestry Disability index"		at 0 days, 21 days, 3 months and 6 months	Yes
Secondary	personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"		at 0 day , 21 days, 3 months, 6 months	Yes
Secondary	fears and the faiths with the FABQ (physical dimension only)		at 0 day , 21 days, 3 months, 6 months	Yes
Secondary	consumption of analgesic estimated by a standardized collection		at 21 days, 3 months, 6 months	Yes
Secondary	expectations and fears by means of individual interview or focus groups by means of the quantitative questionnaire for qualitative analysis.		at 0 day	Yes