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.

NCT02894125 | Completed

• 1 other identifier: CHU-275
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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".

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain; Old subject; SPA Therapy; Pain; Function; Expectations; Fears

Outcome Measures

Primary Outcomes (1)

• Pain's estimation by the digital scale

  at 3 months

Secondary Outcomes (5)

• 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

• fears and the faiths with the FABQ (physical dimension only)

  at 0 day , 21 days, 3 months, 6 months

• consumption of analgesic estimated by a standardized collection

  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.

  at 0 day

Study Arms (1)

old subject

Other: SPA Therapy

Interventions

SPA Therapy OTHER

old subject

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

old subjects with a chronic low back pain

You may qualify if:

• \- Both sexes
• 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)

You may not qualify if:

• \- \< 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (6)

• 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.

  PMID: 17317008 BACKGROUND

• 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.

  PMID: 19734131 BACKGROUND

• 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.

  PMID: 16449365 BACKGROUND

• 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.

  PMID: 16777886 BACKGROUND

• 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.

  PMID: 10201544 BACKGROUND

• 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.

  PMID: 36429387 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bénédicte ESCHALIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

FR (1)