Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients

Low Back Pain Clinical Trial

— PRAMH  

Official title:

Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803501
• Other study ID #: HSalpetrierePRAMH
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2019
• Source: Pitié-Salpêtrière Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: January 1, 2019
• Est. primary completion date: April 1, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• non-specific cLBP (>3 months) with or without radicular pain, not currently in prolonged sick leave, no current indication for surgery, fluent in French, difficulties to maintain daily physical activity due to LBP with Oswestry Disability Index and lumbar and radicular pain at baseline and at end of intervention or 3-month follow-up available.

Exclusion Criteria:

• specific LBP and organic contraindication to physical exercise.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• condensed functional restoration program
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.

Locations

Country	Name	City	State
France	Davergne Thomas	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pitié-Salpêtrière Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	lumbar pain	visual analogue scale (0-100)	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
Secondary	Radicular pain	visual analogue scale (0-100)	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
Secondary	quality of life	EQ5D scale, converted into a global index score with 1 indicating no restriction of quality of life and -1 the worse quality of life possible	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
Secondary	patient acceptable symptom state	where patients reported their satisfaction on state of symptoms by picking "acceptable" or "non acceptable"	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
Secondary	World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism	(reflecting the patient's overall job performance on the days worked during the past 4 weeks, 0-100, 100 being the highest amount of performance)	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
Secondary	relative absenteeism	(rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)	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
Secondary	psychological distress	(Hospital Anxiety and Depression scale)	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