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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback | Experimental | Subjects will be provided with four sessions of supervised biofeedback training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback | Other | Idem as described in the arm section (above) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disability Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Descarreaux, DC, PhD | Université du Québec à Trois-Rivières | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université du Québec à Trois-Rivières | Trois-Rivières | Quebec | G9A 5H7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23777436 | Background | Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60. | |
| 22477926 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biofeedback | Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofeedback | Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Ratio | Week 1 |
|
|
4 weeks
Only pain intensity was collected for adverse events by asking participants if their pain intensity increased at each session beginning.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biofeedback | Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Descarreaux | Université du Québec à Trois-Rivières | 1-819-376-5011 | 3791 | martin.descarreaux@uqtr.ca |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
| Week 4 |
| Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 2 |
| Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 3 |
| Fear of Movement Level | Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level. | Week 4 |
| Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 2 |
| Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 4 |
| Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 3 |
| Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 4 |
| 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 |
| 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 |
| 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 |
| 21306915 | Background | 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. |
| 17174584 | Background | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index, mean (SD) | Mean | Standard Deviation | kg/m^2 |
|
| Duration of low back pain in months, mean (SD) | Mean | Standard Deviation | months |
|
| Fear of movement level | Tampa scale for kinesiophobia ranges from 1 to 68. Higher score indicates a higher fear of movement level. | Mean | Full Range | Units on a scale |
|
| Disability level | Oswestry disability index ranges from 0 to 100. Higher score indicates a higher lumbar disability level. | Mean | Full Range | units on a scale |
|
| Current pain intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Mean | Full Range | Units on a scale |
|
| Pain intensity in the past week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Mean | Full Range | Units on a scale |
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | Week 2 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | Week 3 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | Week 4 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Degrees | Week 1 |
|
|
|
| Secondary | Disability Level | Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability. | Posted | Mean | Full Range | units on a scale | Week 4 |
|
|
|
| Secondary | Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Posted | Mean | Full Range | Units on a scale | Week 2 |
|
|
|
| Secondary | Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Posted | Mean | Full Range | Units on a scale | Week 3 |
|
|
|
| Secondary | Fear of Movement Level | Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level. | Posted | Mean | Full Range | units on a scale | Week 4 |
|
|
|
| Secondary | Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Posted | Mean | Full Range | Units on a scale | Week 2 |
|
|
|
| Secondary | Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Posted | Mean | Full Range | Units on a scale | Week 4 |
|
|
|
| Secondary | Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Posted | Mean | Full Range | Units on a scale | Week 3 |
|
|
|
| Secondary | Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Posted | Mean | Full Range | Units on a scale | Week 4 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Degrees | Week 2 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Degrees | Week 3 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Degrees | Week 4 |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |