OXYLOM: Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients

Sponsor

University Hospital, Lille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03055182

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and healthy people during an original and standardized isokinetic protocol.

The aim of this study is to determine a potential alteration of muscular aerobic metabolism in low back pain patients, in order to establish the underlying cause of pain and muscular fatigability characterizing low back pain patients. Then, the aim is to determine if functional rehabilitation program can improve it.

the unit of care have access to metabolic adaptations in measuring the muscular oxygenation and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Rehabilitation Program Muscular Weakness	Other: Physical rehabilitation program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low back pain patients Subjects included in physical rehabilitation program.	Other: Physical rehabilitation program Patients participate during 4 weeks to a physical rehabilitation program.
No Intervention: Control subjects No intervention administered

Arm

Intervention/Treatment

Experimental: Low back pain patients

Subjects included in physical rehabilitation program.

Other: Physical rehabilitation program

Patients participate during 4 weeks to a physical rehabilitation program.

No Intervention: Control subjects

No intervention administered

Outcome Measures

Primary Outcome Measures

Deoxyhemoglobin [20 minutes]
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)

Secondary Outcome Measures

Oxygen consumption [20 minutes]
Measured in mL/min/kg, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
Work rate [10 minutes]
Total work measured by the dynamometer in Joules during each exercises
Rate of perceived exertion [10 minutes]
Bases on the Borg's Scale, evaluating the perceived exertion on a scale from 6 to 20
Pain [10 minutes]
Bases on a visual analogic scale evaluating the pain on a scale from 0 to 10
Muscular blood volume [20 minutes]
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
Sorensen test [20 minutes]
test is a timed measure used to assess the endurance of the trunk extensor muscles. It is used to assist in the prediction of the incidence and occurrence of low back pain in patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For Low back pain patients: suffering from low back pain for at least 3 month
For control subject: no back pain in the past year

Exclusion Criteria:

Chronic cardiovascular, pulmonary, metabolic, neurologic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Swyngedhauw, CHRU	Lille		France

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: André Thevenon, MD, PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT03055182

Other Study ID Numbers:

2015_58
2016-A01151-50

First Posted:

Feb 16, 2017

Last Update Posted:

Jun 26, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

Additional relevant MeSH terms:

Muscle Weakness

Back Pain

Low Back Pain

Study Results

No Results Posted as of Jun 26, 2019