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Evaluation of Return to Work One Year After a Rehabilitation Program for Chronic Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936725
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

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


Condition or disease Intervention/treatment
Non Specific Chronic Low Back Pain Other: 1 year phone call : data collection

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Evaluation of Return to Work One Year After a Short Rehabilitation Program for Chronic Non Specific Low Back Pain Patients
Actual Study Start Date : May 10, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chronic and non specific low back pain patients
Chronic and non specific low back pain patients
Other: 1 year phone call : data collection

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Absenteeism rate during the 12-month post-program [ Time Frame: 1 year ]
    Absenteeism rate during the 12-month post-program evaluated in days by the questionnaire with suggested answers

  2. The delay of return to work post-program [ Time Frame: 1 year ]
    The delay of return to work post-program evaluated in the day by the questionnaire with suggestion of answers

  3. Conditions of return to work [ Time Frame: 1 year ]
    Conditions of return to work evaluated by several items of the questionnaire with suggested answers

  4. Pain at 1 year post-program [ Time Frame: 1 year ]
    Pain at 1 year post-program evaluated by a numerical scale (EVA)

  5. Physical activity at 1 year post-program [ Time Frame: 1 year ]
    Physical activity at 1 year post-program evaluate by code yes / no

  6. Evaluating intrinsic or extrinsic factors are associated with a professional recovery [ Time Frame: 1 year ]
    evaluate whether certain intrinsic and / or extrinsic factors are possibly associated favorably with a professional recovery



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936725


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Marie HILLION, medical intern CHU de Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03936725    
Other Study ID Numbers: RECHMPL19_0166
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Rehabilitation program
Non specific chronic low back pain
Return to work
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms