Low Back PainOXYLOMNCT03055182
Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients
A study testing Physical rehabilitation program in people with Low Back Pain and Rehabilitation Program, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Rehabilitation Program, Muscular Weakness
- What is being tested?
- Physical rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2017to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Chronic cardiovascular, pulmonary, metabolic, neurologic disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain, Rehabilitation Program, Muscular Weakness
- Being tested
- Physical rehabilitation program
- Keywords
- Isokinetic, oxygenation, deoxygenation, aerobic metabolism
- Medical subject headings
- Low Back Pain, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical rehabilitation programOther
Patients participate during 4 weeks to a physical rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Low back pain patients | Experimental | Subjects included in physical rehabilitation program. Receives: Other: Physical rehabilitation program |
| Control subjects | No intervention | No intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deoxyhemoglobin
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
Measured: 20 minutes
Secondary outcomes (6)
Oxygen consumption
Measured in mL/min/kg, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
Measured: 20 minutes
Work rate
Total work measured by the dynamometer in Joules during each exercises
Measured: 10 minutes
Rate of perceived exertion
Bases on the Borg's Scale, evaluating the perceived exertion on a scale from 6 to 20
Measured: 10 minutes
Pain
Bases on a visual analogic scale evaluating the pain on a scale from 0 to 10
Measured: 10 minutes
Muscular blood volume
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
Measured: 20 minutes
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start11 Jan 2017
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Thevenon, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055182
- Sponsor's protocol ID
- 2015_58
- Other IDs
- 2016-A01151-50
- Acronym
- OXYLOM
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2017
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03055182
- Acronym / sponsor ID
- OXYLOM / 2015_58
- Conditions
- Low Back Pain, Rehabilitation Program, Muscular Weakness
- Keywords
- Isokinetic, oxygenation, deoxygenation, aerobic metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain patients | Experimental | Other: Physical rehabilitation programSubjects included in physical rehabilitation program. |
| Control subjects | No intervention | –No intervention administered |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic cardiovascular, pulmonary, metabolic, neurologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical rehabilitation programPatients participate during 4 weeks to a physical rehabilitation program. | Other | Low back pain patients |
Primary outcome
Deoxyhemoglobin
Time frame: 20 minutes
Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)
6 secondary outcomes
Oxygen consumption
Time frame: 20 minutes
Work rate
Time frame: 10 minutes
Rate of perceived exertion
Time frame: 10 minutes
Pain
Time frame: 10 minutes
Muscular blood volume
Time frame: 20 minutes
Sorensen test
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Thevenon, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical rehabilitation program in people with Low Back Pain and Rehabilitation Program, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deoxyhemoglobin (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.