Low Back PainPRAMHNCT03803501
Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients
An observational study of Low Back Pain, run by Pitié-Salpêtrière Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- condensed functional restoration program
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2014to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with chronic low back pain who participated in the condensed functional restoration program between April 2012 and April 2018
Who may be able to join
- 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.
Who cannot join
- specific LBP and organic contraindication to physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- condensed functional restoration program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
condensed functional restoration programOther
Also called multidisciplinary rehabilitation 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (7)
lumbar pain
visual analogue scale (0-100)
Measured: 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
visual analogue scale (0-100)
Measured: 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
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
Measured: 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
where patients reported their satisfaction on state of symptoms by picking "acceptable" or "non acceptable"
Measured: 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
(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)
Measured: 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
relative absenteeism
(rapport between the hours lost and the hours expected to work per month, 0-100, 100 indicates the higher amount of absenteeism)
Measured: 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
psychological distress
(Hospital Anxiety and Depression scale)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Apr 2014
- Primary completion1 Apr 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pitié-Salpêtrière Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Davergne, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803501
- Sponsor's protocol ID
- HSalpetrierePRAMH
- Acronym
- PRAMH
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients
- ClinicalTrials.gov ID
- NCT03803501
- Acronym / sponsor ID
- PRAMH / HSalpetrierePRAMH
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Pitié-Salpêtrière HospitalUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain who participated in the condensed functional restoration program between April 2012 and April 2018
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- specific LBP and organic contraindication to physical exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| condensed functional restoration programAlso: multidisciplinary rehabilitation programThe 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 | – |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Pitié-Salpêtrière Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.