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

• ClinicalTrials.gov Identifier: NCT02239289
• Recruitment Status: Completed
• First Posted: September 12, 2014
• Results First Posted: July 23, 2015
• Last Update Posted: July 23, 2015
• Sponsor: Université du Québec à Trois-Rivières
• Information provided by (Responsible Party): Martin Descarreaux, Université du Québec à Trois-Rivières

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain; Mechanical Low Back Pain	Other: Biofeedback	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training
• Study Start Date: March 2014
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Biofeedback; Subjects will be provided with four sessions of supervised biofeedback training	Other: Biofeedback; Idem as described in the arm section (above)

Outcome Measures

Primary Outcome Measures :

1. Flexion-relaxation Ratio [ Time Frame: Week 1 ]
   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.
2. Flexion-relaxation Ratio [ Time Frame: Week 2 ]
   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.
3. Flexion-relaxation Ratio [ Time Frame: Week 3 ]
   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.
4. Flexion-relaxation Ratio [ Time Frame: Week 4 ]
   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 :

1. Lumbo-pelvic Range of Motion During Trunk Flexion-extension [ Time Frame: Week 1 ]
   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.
2. Disability Level [ Time Frame: Week 4 ]
   Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
3. Pain Intensity in the Past Week [ Time Frame: Week 2 ]
   101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
4. Current Pain Intensity [ Time Frame: Week 3 ]
   101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
5. Fear of Movement Level [ Time Frame: Week 4 ]
   Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.
6. Current Pain Intensity [ Time Frame: Week 2 ]
   101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
7. Current Pain Intensity [ Time Frame: Week 4 ]
   101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
8. Pain Intensity in the Past Week [ Time Frame: Week 3 ]
   101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
9. Pain Intensity in the Past Week [ Time Frame: Week 4 ]
   101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
10. Lumbo-pelvic Range of Motion During Trunk Flexion-extension [ Time Frame: Week 2 ]
    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.
11. Lumbo-pelvic Range of Motion During Trunk Flexion-extension [ Time Frame: Week 3 ]
    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.
12. Lumbo-pelvic Range of Motion During Trunk Flexion-extension [ Time Frame: Week 4 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Quebec

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada, G9A 5H7

Sponsors and Collaborators

Université du Québec à Trois-Rivières

Investigators

• Principal Investigator: Martin Descarreaux, DC, PhD; Université du Québec à Trois-Rivières

More Information

Publications:

Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60. Review.

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.

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. Review.

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. Epub 2006 Nov 13. Review.

• Responsible Party: Martin Descarreaux, Professor, Université du Québec à Trois-Rivières
• ClinicalTrials.gov Identifier: NCT02239289
• Other Study ID Numbers: FIR UQTR 2013-2014
• First Posted: September 12, 2014
• Results First Posted: July 23, 2015
• Last Update Posted: July 23, 2015
• Last Verified: July 2015

Keywords provided by Martin Descarreaux, Université du Québec à Trois-Rivières:

Low back pain; Rehabilitation; Biofeedback; Electromyography; Kinematic

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations