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

June 25, 2019 updated by: University Hospital, Lille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Swyngedhauw, CHRU
        • Principal Investigator:
          • André Thevenon, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deoxyhemoglobin
Time Frame: 20 minutes
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen consumption
Time Frame: 20 minutes
Measured in mL/min/kg, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
20 minutes
Work rate
Time Frame: 10 minutes
Total work measured by the dynamometer in Joules during each exercises
10 minutes
Rate of perceived exertion
Time Frame: 10 minutes
Bases on the Borg's Scale, evaluating the perceived exertion on a scale from 6 to 20
10 minutes
Pain
Time Frame: 10 minutes
Bases on a visual analogic scale evaluating the pain on a scale from 0 to 10
10 minutes
Muscular blood volume
Time Frame: 20 minutes
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
20 minutes
Sorensen test
Time Frame: 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.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_58
  • 2016-A01151-50 (Other Identifier: ID_RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Physical rehabilitation program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe