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NCT03055182 Clinical Trial

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

Low Back Pain Clinical Trial

— OXYLOM  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03055182
Other study ID # 2015_58
Secondary ID 2016-A01151-50
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date December 2019

Study information
Verified date June 2019
Source University Hospital, Lille
Contact Andre Thevenon, MD,PhD
Phone 0320445830
Email andre.thevenon@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Physical rehabilitation program
Patients participate during 4 weeks to a physical rehabilitation program.

Locations
Country Name City State
France Hôpital Swyngedhauw, CHRU Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

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