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CompletedNCT03055182OXYLOMUpdated Dec 23, 2025

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

An interventional study of Physical rehabilitation program in Low Back Pain, Rehabilitation Program and Muscular Weakness, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
  • Rehabilitation Program
  • Muscular Weakness

Keywords

  • Isokinetic
  • oxygenation
  • deoxygenation
  • aerobic metabolism
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Chronic cardiovascular, pulmonary, metabolic, neurologic disease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Low back pain patients

    Subjects included in physical rehabilitation program.

    Other: Physical rehabilitation program

  • No intervention
    Control subjects

    No intervention administered

Interventions

  • OtherPhysical rehabilitation program

    Patients participate during 4 weeks to a physical rehabilitation program.

06

What researchers measure

Primary outcomes

  1. Deoxyhemoglobin

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

    Time frame: 20 minutes

Secondary outcomes

  1. Oxygen consumption

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

    Time frame: 20 minutes

  2. Work rate

    Total work measured by the dynamometer in Joules during each exercises

    Time frame: 10 minutes

  3. Rate of perceived exertion

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

    Time frame: 10 minutes

  4. Pain

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

    Time frame: 10 minutes

  5. Muscular blood volume

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

    Time frame: 20 minutes

  6. 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.

    Time frame: 20 minutes

07

Study locations

1 site
  • Hôpital Swyngedhauw, CHRU
    Lille, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03055182
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Feb 16, 2017
Start date
Jan 11, 2017
Primary completion
Dec 10, 2024
Completion
Dec 10, 2024
Last update
Dec 23, 2025

Study contacts

André Thevenon, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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