Non Specific Chronic Low Back PainNCT03936725
Evaluation of Return to Work One Year After a Rehabilitation Program for Chronic Back Pain
An observational study of Non Specific Chronic Low Back Pain, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Return to work is one of the essential objectives of functional spinal restoration programs. When the duration of the work stoppage increases, the chances of returning to work become worse. No studies have yet evaluated the value of a short 2-week restoration program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Specific Chronic Low Back Pain
- What is being tested?
- 1 year phone call : data collection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2019to 30 May 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who participated in the functional spine rehabilitation program proposed by the department of Physical Medicine and Rehabilitation of the University Hospital of Lapeyronie in Montpellier
Who may be able to join
- age between 18 and 65 years
- lumbalgia for more than 12 weeks labeled nonspecific (= common mechanics)
- have benefited fully from the 2-week day hospital rehabilitation program.
Who cannot join
- secondary low back pain
- immediate postoperative hospitalization (<3 months)
- patient who died at the time of the study
- non-updated telephone numbers
- housewife, students subject subject to protection (curatorship, safeguard of justice, guardianship)
- Serious co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Return to Work One Year After a Short Rehabilitation Program for Chronic Non Specific Low Back Pain Patients
Return to work is one of the essential objectives of functional spinal restoration programs. When the duration of the work stoppage increases, the chances of returning to work become worse. No studies have yet evaluated the value of a short 2-week restoration program.
The purpose of this study is to determine whether a 2-week functional restoration program regains a return-to-work rate similar to longer-term restoration programs at one year post-program.
Read more
This retrospective study with prospective referral included 200 patients with non specific chronic low-back pain who participated in a self-care rehabilitation program between May 2018 and May 2019. The program included both physical and educational approaches to dealing with the condition. The duration was two weeks with follow-up at three months.
The main evaluation criterion was to evaluate the return to work rate by telephone at one year post-program. Secondary objectives were to observe return-to-work conditions, absenteeism, recovery time, pain and physical activity at one year post-program and also to observe if there was a possible association between intrinsic/extrinsic factors and return to work
Read the detailed description
Patients were included in the study from May 2019 to May 2020 if they had chronic nonspecific low back pain of more than 12 weeks according to the French health authority (High Authority of Health).
The data for this study were collected after validation by the ethics committee (Institutional Review Board). Initial data were collected from generation of a list of computerized medical records of low back pain patients who participated in the program between May 2018 and May 2019 and were hospitalized in the day or week area of follow-up and rehabilitative care : age, sex, BMI, marital status, clinical elements related to the low-back pain (total duration of low back pain, history of spine surgery, last spinal imaging, pain measured on a visual analog scale, analgesic consumption, tobacco consumption, physical activity, self-exercise, physiotherapy, Schober index, finger-ground distance, poplitates angles, heel-buttock distance) and professional situation (professional status, carrying heavy loads, sick leave accumulated prior hospitalization for back pain, professional status, occupational disease, occupational accident, disability, half-time therapy).
One-year post-program data were collected by telephone after consent was received. The investigators collected the date of return to work, elements concerning the conditions of return to work (modification of the previous position, working time, type of contract, work stoppages related to back pain, evolution of global job satisfaction before/after program ) and clinical elements (change in pain after the program, physical activity, self-stretching exercises, spine operation after the program,satisfaction of the rehabilitation program, benefit provided by the program).
Reference Methodology MR-004 was applied to the study after approval by the Data Protection Officer (CNIL). An information letter was sent to the selected patients to comply with the applicable regulations (RGPD). The patient was not included if he returned the non-consent form.
Program : The duration of hospitalization was 2 weeks and the care program was delivered, for each patient, by the same medical and paramedical team including doctors, physiotherapists, occupational therapists, a nurse. There was no change in the program during the 2018-2019 year, so the hospitalized patients received the same program. The functional restoration program included stretching and muscle strengthening of the spine and sub-pelvic planes, abdominal sheathing, gymnastics, exercise re-training sessions, self-exercise training, balneotherapy, relaxation sessions, sessions of body awareness and ergonomics.
- Conditions
- Non Specific Chronic Low Back Pain
- Being tested
- 1 year phone call : data collection
- Keywords
- Rehabilitation program, Non specific chronic low back pain, Return to work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 year phone call : data collectionOther
Included patients are contacted by telephone at 12 months after discharge. The investigators explain to the patient that this call is in the same context as a regular follow-up rehabilitation consultation and that the data collected will also be part of a study to evaluate and improve the program in which they participated. The interview will be transcribed in writing in their computerized and secure medical file. During this 20-minute telephone conversation, the patient answers a number of questions via a standardized questionnaire, in order to gather the various criteria for judgment.
If patients do not answer the first call, a phone message will be left and they will be contacted again up to 2 times. Patients who do not respond to 3 calls will be considered lost to follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Chronic and non specific low back pain patients | Chronic and non specific low back pain patients Receives: Other: 1 year phone call : data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work at one year post-program
code yes/no in the questionnaire with date of return to work after program.
Measured: 1 year
Secondary outcomes (6)
Absenteeism rate during the 12-month post-program
Absenteeism rate during the 12-month post-program evaluated in days by the questionnaire with suggested answers
Measured: 1 year
The delay of return to work post-program
The delay of return to work post-program evaluated in the day by the questionnaire with suggestion of answers
Measured: 1 year
Conditions of return to work
Conditions of return to work evaluated by several items of the questionnaire with suggested answers
Measured: 1 year
Pain at 1 year post-program
Pain at 1 year post-program evaluated by a numerical scale (EVA)
Measured: 1 year
Physical activity at 1 year post-program
Physical activity at 1 year post-program evaluate by code yes / no
Measured: 1 year
Evaluating intrinsic or extrinsic factors are associated with a professional recovery
evaluate whether certain intrinsic and / or extrinsic factors are possibly associated favorably with a professional recovery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start10 May 2019
- Primary completion1 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie HILLION, medical intern, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936725
- Sponsor's protocol ID
- RECHMPL19_0166
- Status last verified
- Jun 2020
- First submitted
- 26 Apr 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Return to Work One Year After a Short Rehabilitation Program for Chronic Non Specific Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03936725
- Acronym / sponsor ID
- RECHMPL19_0166
- Conditions
- Non Specific Chronic Low Back Pain
- Keywords
- Rehabilitation program, Non specific chronic low back pain, Return to work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 3 May 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.
Return to work is one of the essential objectives of functional spinal restoration programs. When the duration of the work stoppage increases, the chances of returning to work become worse. No studies have yet evaluated the value of a short 2-week restoration program.
The purpose of this study is to determine whether a 2-week functional restoration program regains a return-to-work rate similar to longer-term restoration programs at one year post-program.
This retrospective study with prospective referral included 200 patients with non specific chronic low-back pain who participated in a self-care rehabilitation program between May 2018 and May 2019. The program included both physical and educational approaches to dealing with the condition. The duration was two weeks with follow-up at three months.
The main evaluation criterion was to evaluate the return to work rate by telephone at one year post-program. Secondary objectives were to observe return-to-work conditions, absenteeism, recovery time, pain and physical activity at one year post-program and also to observe if there was a possible association between intrinsic/extrinsic factors and return to work
Detailed description
Patients were included in the study from May 2019 to May 2020 if they had chronic nonspecific low back pain of more than 12 weeks according to the French health authority (High Authority of Health).
The data for this study were collected after validation by the ethics committee (Institutional Review Board). Initial data were collected from generation of a list of computerized medical records of low back pain patients who participated in the program between May 2018 and May 2019 and were hospitalized in the day or week area of follow-up and rehabilitative care : age, sex, BMI, marital status, clinical elements related to the low-back pain (total duration of low back pain, history of spine surgery, last spinal imaging, pain measured on a visual analog scale, analgesic consumption, tobacco consumption, physical activity, self-exercise, physiotherapy, Schober index, finger-ground distance, poplitates angles, heel-buttock distance) and professional situation (professional status, carrying heavy loads, sick leave accumulated prior hospitalization for back pain, professional status, occupational disease, occupational accident, disability, half-time therapy).
One-year post-program data were collected by telephone after consent was received. The investigators collected the date of return to work, elements concerning the conditions of return to work (modification of the previous position, working time, type of contract, work stoppages related to back pain, evolution of global job satisfaction before/after program ) and clinical elements (change in pain after the program, physical activity, self-stretching exercises, spine operation after the program,satisfaction of the rehabilitation program, benefit provided by the program).
Reference Methodology MR-004 was applied to the study after approval by the Data Protection Officer (CNIL). An information letter was sent to the selected patients to comply with the applicable regulations (RGPD). The patient was not included if he returned the non-consent form.
Program : The duration of hospitalization was 2 weeks and the care program was delivered, for each patient, by the same medical and paramedical team including doctors, physiotherapists, occupational therapists, a nurse. There was no change in the program during the 2018-2019 year, so the hospitalized patients received the same program. The functional restoration program included stretching and muscle strengthening of the spine and sub-pelvic planes, abdominal sheathing, gymnastics, exercise re-training sessions, self-exercise training, balneotherapy, relaxation sessions, sessions of body awareness and ergonomics.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic and non specific low back pain patients | – | Other: 1 year phone call : data collectionChronic and non specific low back pain patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in the functional spine rehabilitation program proposed by the department of Physical Medicine and Rehabilitation of the University Hospital of Lapeyronie in Montpellier
Key inclusion criteria (3 listed)
- age between 18 and 65 years
- lumbalgia for more than 12 weeks labeled nonspecific (= common mechanics)
- have benefited fully from the 2-week day hospital rehabilitation program.
Key exclusion criteria (6 listed)
- secondary low back pain
- immediate postoperative hospitalization (<3 months)
- patient who died at the time of the study
- non-updated telephone numbers
- housewife, students subject subject to protection (curatorship, safeguard of justice, guardianship)
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 |
|---|---|---|
| 1 year phone call : data collectionIncluded patients are contacted by telephone at 12 months after discharge. The investigators explain to the patient that this call is in the same context as a regular follow-up rehabilitation consultation and that the data collected will also be part of a study to evaluate and improve the program in which they participated. The interview will be transcribed in writing in their computerized and secure medical file. During this 20-minute telephone conversation, the patient answers a number of questions via a standardized questionnaire, in order to gather the various criteria for judgment. If patients do not answer the first call, a phone message will be left and they will be contacted again up to 2 times. Patients who do not respond to 3 calls will be considered lost to follow-up. | Other | Chronic and non specific low back pain patients |
Primary outcome
Return to work at one year post-program
Time frame: 1 year
code yes/no in the questionnaire with date of return to work after program.
6 secondary outcomes
Absenteeism rate during the 12-month post-program
Time frame: 1 year
The delay of return to work post-program
Time frame: 1 year
Conditions of return to work
Time frame: 1 year
Pain at 1 year post-program
Time frame: 1 year
Physical activity at 1 year post-program
Time frame: 1 year
Evaluating intrinsic or extrinsic factors are associated with a professional recovery
Time frame: 1 year
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 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Non Specific Chronic Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
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Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
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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.
Marie HILLION, medical intern principal investigator
CHU de Montpellier
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 Non Specific Chronic Low Back Pain, run by University Hospital, Montpellier 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 3 inclusion and 6 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 5 Jun 2020. 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?
Return to work at one year post-program (time frame: 1 year). 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 5 Jun 2020.