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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT03055182
First received: February 7, 2017
Last updated: February 13, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention
Low Back Pain
Rehabilitation Program
Muscular Weakness
Other: Physical rehabilitation program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Deoxyhemoglobin [ Time Frame: 20 minutes ]
    Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)


Secondary Outcome Measures:
  • Oxygen consumption [ Time Frame: 20 minutes ]
    Measured in mL/min/kg, at rest and during the isokinetic exercises (2 exercises of 5 minutes)

  • Work rate [ Time Frame: 10 minutes ]
    Total work measured by the dynamometer in Joules during each exercises

  • 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

  • Pain [ Time Frame: 10 minutes ]
    Bases on a visual analogic scale evaluating the pain on a scale from 0 to 10

  • Muscular blood volume [ Time Frame: 20 minutes ]
    Expressed in arbitrary unit, at rest and during the isokinetic exercises (2 exercises of 5 minutes)


Estimated Enrollment: 36
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low back pain patients
Subjects included in physical rehabilitation program.
Other: Physical rehabilitation program
Patients participate during 4 weeks to a physical rehabilitation program.
No Intervention: Control subjects
No intervention administered

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03055182

Contacts
Contact: Andre Thevenon, MD,PhD andre.thevenon@chru-lille.fr

Locations
France
Hôpital Swyngedhauw, CHRU Not yet recruiting
Lille, France
Principal Investigator: André Thevenon, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: André Thevenon, MD, PhD University Hospital, Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03055182     History of Changes
Other Study ID Numbers: 2015_58
2016-A01151-50 ( Other Identifier: ID_RCB Number )
Study First Received: February 7, 2017
Last Updated: February 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Isokinetic
oxygenation
deoxygenation
aerobic metabolism

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Muscle Weakness
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on March 28, 2017