NCT03055182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

7.9 years

First QC Date

February 7, 2017

Last Update Submit

December 16, 2025

Conditions

Keywords

Isokineticoxygenationdeoxygenationaerobic metabolism

Outcome Measures

Primary Outcomes (1)

  • Deoxyhemoglobin

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

    20 minutes

Secondary Outcomes (6)

  • Oxygen consumption

    20 minutes

  • Work rate

    10 minutes

  • Rate of perceived exertion

    10 minutes

  • Pain

    10 minutes

  • Muscular blood volume

    20 minutes

  • +1 more secondary outcomes

Study Arms (2)

Low back pain patients

EXPERIMENTAL

Subjects included in physical rehabilitation program.

Other: Physical rehabilitation program

Control subjects

NO INTERVENTION

No intervention administered

Interventions

Patients participate during 4 weeks to a physical rehabilitation program.

Low back pain patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic cardiovascular, pulmonary, metabolic, neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Swyngedhauw, CHRU

Lille, France

Location

MeSH Terms

Conditions

Low Back PainMuscle Weakness

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNervous System DiseasesPathologic Processes

Study Officials

  • André Thevenon, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 16, 2017

Study Start

January 11, 2017

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations