NCT02894125|Completed
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Sponsor study identifier
observational
100
1 country
1
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
August 2016
Actual (reported)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".
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)August 2016
Actual (reported)September 5, 2016
Actual (reported)September 9, 2016
Actual (reported)Pain's estimation by the digital scale
at 3 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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
old subjects with a chronic low back pain
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
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.
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.
Bénédicte ESCHALIER
University Hospital, Clermont-Ferrand
100 participants (actual enrollment reported by the registry).
First Submitted
September 5, 2016
First Posted
September 9, 2016
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Single-Case Study on Therapeutic Change in Chronic Low Back Pain
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
June 2016
Actual (reported)Study Completion
August 2016
Actual (reported)Last Updated
September 12, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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