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Completed

NCT Number: NCT03055182

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

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.

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Key information

Conditions

Low Back Pain Back Pain Muscle Weakness Muscular Diseases Muscular Weakness Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rehabilitation Program Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Swyngedhauw, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Rehabilitation program

Other

Patients participate during 4 weeks to a physical rehabilitation program.

Primary outcomes

  1. Deoxyhemoglobin

    Time frame: 20 minutes

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

Secondary outcomes

  1. Oxygen consumption

    Time frame: 20 minutes

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

  2. Work rate

    Time frame: 10 minutes

    Total work measured by the dynamometer in Joules during each exercises

  3. 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

  4. Pain

    Time frame: 10 minutes

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

  5. Muscular blood volume

    Time frame: 20 minutes

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

  6. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: OXYLOM

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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