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Completed

NCT Number: NCT03803501

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Davergne Thomas

Paris, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

condensed functional restoration program

Other

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.

Other names: multidisciplinary rehabilitation program

Primary outcomes

  1. Oswestry disability index

    Time frame: 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

    gives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state

Secondary outcomes

  1. lumbar pain

    Time frame: 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

    visual analogue scale (0-100)

  2. Radicular pain

    Time frame: 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

    visual analogue scale (0-100)

  3. quality of life

    Time frame: 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

    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

  4. patient acceptable symptom state

    Time frame: 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

    where patients reported their satisfaction on state of symptoms by picking "acceptable" or "non acceptable"

  5. World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism

    Time frame: 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

    (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)

  6. relative absenteeism

    Time frame: 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

    (rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)

  7. psychological distress

    Time frame: 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

    (Hospital Anxiety and Depression scale)

Sponsors and collaborators

Lead sponsor

Pitié-Salpêtrière Hospital

Other

Registry information

Acronym: PRAMH

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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