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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04133818
Other study ID # LC-ONE
Secondary ID APHP190887
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date September 30, 2019

Study information

Verified date October 2019
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.


Description:

Retrospectively, data of patients between 18 and 60 years who had benefited in the PMR unit of Cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected.

This no intensive multidisciplinary education and exercise therapy program is proposed by the PMR unit of Cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated.

It is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist.

Data regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 30, 2019
Est. primary completion date April 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age = 18 years

- subacute or chronic non-specific LBP = 6 weeks

- no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific LBP

- currently working

- written consent

Exclusion Criteria:

- inability to speak or read French

- cognitive impairment

- current sick leave

- history of intensive multidisciplinary rehabilitation program for LBP

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multidisciplinary education and exercise therapy program
Multidisciplinary program: one and a half day of education and exercise therapy about low back pain : Lectures and explanations about low back pain Physical activity Relaxation

Locations

Country Name City State
France Hôpital Cochin Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol The — View Citation

Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. Epub 2007 Nov 19. Review. — View Citation

Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability Acceptability of the program by the patients (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the best acceptability and 0 the lowest acceptability) 3 months
Secondary Efficiency Efficiency of the program to diminish pain (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the most important pain and 0 no pain at all) 3 months
Secondary Efficiency Efficiency of the program to diminish fear and beliefs (FABQ, between 0 and 66 with 66 representing the highest level of fear and beliefs about low back pain and 0 representing no fear and beliefs about low back pain) 3 months
See also
  Status Clinical Trial Phase
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