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

Primary Purpose

Low Back Pain, Rehabilitation Program, Muscular Weakness

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Physical rehabilitation program

About this trial

This is an interventional basic science trial for Low Back Pain focused on measuring Isokinetic, oxygenation, deoxygenation, aerobic metabolism

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hôpital Swyngedhauw, CHRURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low back pain patients

Control subjects

Arm Description

Subjects included in physical rehabilitation program.

No intervention administered

Outcomes

Primary Outcome Measures

Deoxyhemoglobin

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

Secondary Outcome Measures

Oxygen consumption

Measured in mL/min/kg, at rest and during the isokinetic exercises (2 exercises of 5 minutes)

Work rate

Total work measured by the dynamometer in Joules during each exercises

Rate of perceived exertion

Bases on the Borg's Scale, evaluating the perceived exertion on a scale from 6 to 20

Pain

Bases on a visual analogic scale evaluating the pain on a scale from 0 to 10

Muscular blood volume

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

Sorensen test

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.

Full Information

NCT ID

NCT03055182

First Posted

February 7, 2017

Last Updated

June 25, 2019

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT03055182

Brief Title

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

Acronym

OXYLOM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Rehabilitation Program, Muscular Weakness

Keywords

Isokinetic, oxygenation, deoxygenation, aerobic metabolism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low back pain patients

Arm Type

Experimental

Arm Description

Subjects included in physical rehabilitation program.

Arm Title

Control subjects

Arm Type

No Intervention

Arm Description

No intervention administered

Intervention Type

Other

Intervention Name(s)

Physical rehabilitation program

Intervention Description

Patients participate during 4 weeks to a physical rehabilitation program.

Primary Outcome Measure Information:

Title

Deoxyhemoglobin

Description

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

Time Frame

20 minutes

Secondary Outcome Measure Information:

Title

Oxygen consumption

Description

Measured in mL/min/kg, at rest and during the isokinetic exercises (2 exercises of 5 minutes)

Time Frame

20 minutes

Title

Work rate

Description

Total work measured by the dynamometer in Joules during each exercises

Time Frame

10 minutes

Title

Rate of perceived exertion

Description

Bases on the Borg's Scale, evaluating the perceived exertion on a scale from 6 to 20

Time Frame

10 minutes

Title

Pain

Description

Bases on a visual analogic scale evaluating the pain on a scale from 0 to 10

Time Frame

10 minutes

Title

Muscular blood volume

Description

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

Time Frame

20 minutes

Title

Sorensen test

Description

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.

Time Frame

20 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andre Thevenon, MD,PhD

Phone

0320445830

andre.thevenon@chru-lille.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

André Thevenon, MD, PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Swyngedhauw, CHRU

City

Lille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

André Thevenon, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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