NCT03936725

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

April 26, 2019

Last Update Submit

June 4, 2020

Conditions

Keywords

Rehabilitation programNon specific chronic low back painReturn to work

Outcome Measures

Primary Outcomes (1)

  • Return to work at one year post-program

    code yes/no in the questionnaire with date of return to work after program.

    1 year

Secondary Outcomes (6)

  • Absenteeism rate during the 12-month post-program

    1 year

  • The delay of return to work post-program

    1 year

  • Conditions of return to work

    1 year

  • Pain at 1 year post-program

    1 year

  • Physical activity at 1 year post-program

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Chronic and non specific low back pain patients

Chronic and non specific low back pain patients

Other: 1 year phone call : data collection

Interventions

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.

Chronic and non specific low back pain patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Study Officials

  • Marie HILLION, medical intern

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 3, 2019

Study Start

May 10, 2019

Primary Completion

May 1, 2020

Study Completion

May 30, 2020

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations