NCT03803501|Completed
Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients
PRAMH
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PRAMH
Sponsor study identifier
observational
193
1 country
1
Study Start
April 1, 2014
Actual (reported)Primary Completion
April 1, 2018
Actual (reported)Study Completion
January 1, 2019
Actual (reported)The aim was to assess the effectiveness of a condensed functional restoration program (CFRP) for patients with chronic low back pain and professional activity. Methods: Longitudinal 1 to 3 months study of patients with non-specific chronic low back pain in one tertiary care hospital, participating in a CFRP (complex interprofessional intervention over 4 days). The primary outcome was the Oswestry Disability Index (ODI) (0-100 scale). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom state, presenteeism, absenteeism and psychological distress (Hospital Anxiety and Depression scale). Outcomes were compared using paired sample Student's t-test or Chi2 between baseline and last follow-up. Logistic regression was used to identify factors associated with better response (improvement of ODI higher than 12.8) and included baseline demographic, psychological and physical assessment variables.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2019
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.
April 1, 2014
Actual (reported)April 1, 2018
Actual (reported)January 1, 2019
Actual (reported)January 8, 2019
Actual (reported)January 14, 2019
Actual (reported)Oswestry disability index
gives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state
change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
lumbar pain
change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
Radicular pain
change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
quality of life
change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
patient acceptable symptom state
change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism
change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available
The condensed functional restoration program (CFRP) is a complex multidisciplinary intervention proposed as usual care according to international guidelines. The program takes place in our department of rheumatology, 6 hours per day, 1 day a week, for 4 weeks. Patients are included during consultation or Hospitalisation and are in groups of 6 maximum per FRP. The CRFP was developed on the basis of therapeutic patient education programs and physical exercises (Van Wambeke 2017, Desthieux 2014). Three hours per day are devoted to physical exercises which were divided into three periods: warming, stretching, and muscular strengthening. Specific exercises adapted to work circumstances (like manutention) are taught. Muscular strengthening is based on isotonic contraction on fitness devices. Education is based on 1 hour long educative session adapted from back school programs once a week. Educative booklets are also given to the patients.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with chronic low back pain who participated in the condensed functional restoration program between April 2012 and April 2018
Davergne Thomas
Paris, France
193 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2019
First Posted
January 14, 2019
Study Start
April 1, 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 1, 2018
Actual (reported)Study Completion
January 1, 2019
Actual (reported)Last Updated
January 15, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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