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

Not Applicable

• Conditions: Rehabilitation Program; Low Back Pain; Muscular Weakness
• Interventions: Other: Physical rehabilitation program

• Registration Number: NCT03055182
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Low back pain patients	Physical rehabilitation program	Subjects included in physical rehabilitation program.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Swyngedhauw, CHRU; 🇫🇷 Lille, France