Clinical trial NCT02239289: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Mechanical Low Back Pain
Keywords: Low back pain
Rehabilitation
Biofeedback
Electromyography
Kinematic
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Flexion-relaxation Ratio
timeFrame: Week 1
measure: Flexion-relaxation Ratio
timeFrame: Week 2
measure: Flexion-relaxation Ratio
timeFrame: Week 3
measure: Flexion-relaxation Ratio
timeFrame: Week 4
Secondary outcomes:
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
timeFrame: Week 1
measure: Disability Level
timeFrame: Week 4
measure: Pain Intensity in the Past Week
timeFrame: Week 2
measure: Current Pain Intensity
timeFrame: Week 3
measure: Fear of Movement Level
timeFrame: Week 4
measure: Current Pain Intensity
timeFrame: Week 2
measure: Current Pain Intensity
timeFrame: Week 4
measure: Pain Intensity in the Past Week
timeFrame: Week 3
measure: Pain Intensity in the Past Week
timeFrame: Week 4
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
timeFrame: Week 2
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
timeFrame: Week 3
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
timeFrame: Week 4
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.