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

Chronic Low Back Pain Clinical Trial

Official title:

Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239289
• Other study ID #: FIR UQTR 2013-2014
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: July 10, 2015
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Other:
• Biofeedback
Idem as described in the arm section (above)

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 1	No
Primary	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.	Week 2	No
Primary	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.	Week 3	No
Primary	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.	Week 4	No
Secondary	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.	Week 1	No
Secondary	Disability Level	Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.	Week 4	No
Secondary	Pain Intensity in the Past Week	101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).	Week 2	No
Secondary	Current Pain Intensity	101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).	Week 3	No
Secondary	Fear of Movement Level	Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.	Week 4	No
Secondary	Current Pain Intensity	101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).	Week 2	No
Secondary	Current Pain Intensity	101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).	Week 4	No
Secondary	Pain Intensity in the Past Week	101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).	Week 3	No
Secondary	Pain Intensity in the Past Week	101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).	Week 4	No
Secondary	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.	Week 2	No
Secondary	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.	Week 3	No
Secondary	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.	Week 4	No