search
Back to results

Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients

Primary Purpose

Chronic Low Back Pain, Mechanical Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low back pain, Rehabilitation, Biofeedback, Electromyography, Kinematic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being between 18 and 60 years of age.
  • Presence of non-specific chronic low back pain.

Exclusion Criteria:

  • Prior surgery or major spine trauma.
  • Lumbar scoliosis greater than 20°.
  • Neuromuscular disease.
  • Malignant tumor.
  • Uncontrolled hypertension.
  • Infection.
  • Neurological deficit.
  • Symptomatic lumbar disc herniation.
  • Pregnancy.
  • Recent lumbar cortisone injection.
  • Active lower body injury and/or disabling pain limiting the capacity to complete the experimentation.
  • Being under medications known to impair physical effort and pain perception.

Sites / Locations

  • Université du Québec à Trois-Rivières

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biofeedback

Arm Description

Subjects will be provided with four sessions of supervised biofeedback training

Outcomes

Primary Outcome Measures

Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.

Secondary Outcome Measures

Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Disability Level
Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Fear of Movement Level
Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.

Full Information

First Posted
September 4, 2014
Last Updated
July 10, 2015
Sponsor
Université du Québec à Trois-Rivières
search

1. Study Identification

Unique Protocol Identification Number
NCT02239289
Brief Title
Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients
Official Title
Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to evaluate the benefit of biofeedback training on the capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles activity during trunk full flexion and its relationship with changes in clinical outcomes. To do so, twenty patients with nonspecific mechanical low back pain will be recruited and all participants will take part in four sessions of supervised biofeedback training, consisting of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that participants will have improved neuromechanical parameters with the biofeedback training and that this improvement will be positively associated to changes in clinical outcomes. This study will also allow for generation of preliminary data, in order to plan for a larger randomized control trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Mechanical Low Back Pain
Keywords
Low back pain, Rehabilitation, Biofeedback, Electromyography, Kinematic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
Subjects will be provided with four sessions of supervised biofeedback training
Intervention Type
Other
Intervention Name(s)
Biofeedback
Intervention Description
Idem as described in the arm section (above)
Primary Outcome Measure Information:
Title
Flexion-relaxation Ratio
Description
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Time Frame
Week 1
Title
Flexion-relaxation Ratio
Description
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Time Frame
Week 2
Title
Flexion-relaxation Ratio
Description
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Time Frame
Week 3
Title
Flexion-relaxation Ratio
Description
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Description
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Time Frame
Week 1
Title
Disability Level
Description
Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
Time Frame
Week 4
Title
Pain Intensity in the Past Week
Description
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time Frame
Week 2
Title
Current Pain Intensity
Description
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time Frame
Week 3
Title
Fear of Movement Level
Description
Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.
Time Frame
Week 4
Title
Current Pain Intensity
Description
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time Frame
Week 2
Title
Current Pain Intensity
Description
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time Frame
Week 4
Title
Pain Intensity in the Past Week
Description
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time Frame
Week 3
Title
Pain Intensity in the Past Week
Description
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time Frame
Week 4
Title
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Description
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Time Frame
Week 2
Title
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Description
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Time Frame
Week 3
Title
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Description
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between 18 and 60 years of age. Presence of non-specific chronic low back pain. Exclusion Criteria: Prior surgery or major spine trauma. Lumbar scoliosis greater than 20°. Neuromuscular disease. Malignant tumor. Uncontrolled hypertension. Infection. Neurological deficit. Symptomatic lumbar disc herniation. Pregnancy. Recent lumbar cortisone injection. Active lower body injury and/or disabling pain limiting the capacity to complete the experimentation. Being under medications known to impair physical effort and pain perception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Descarreaux, DC, PhD
Organizational Affiliation
Université du Québec à Trois-Rivières
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université du Québec à Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G9A 5H7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23777436
Citation
Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
Results Reference
background
PubMed Identifier
22477926
Citation
Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.
Results Reference
background
PubMed Identifier
21306915
Citation
Hodges PW. Pain and motor control: From the laboratory to rehabilitation. J Electromyogr Kinesiol. 2011 Apr;21(2):220-8. doi: 10.1016/j.jelekin.2011.01.002.
Results Reference
background
PubMed Identifier
17174584
Citation
Demoulin C, Crielaard JM, Vanderthommen M. Spinal muscle evaluation in healthy individuals and low-back-pain patients: a literature review. Joint Bone Spine. 2007 Jan;74(1):9-13. doi: 10.1016/j.jbspin.2006.02.013. Epub 2006 Nov 13.
Results Reference
background

Learn more about this trial

Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients

We'll reach out to this number within 24 hrs