Chronic Low Back Pain, Mechanical Low Back Pain
Conditions
Keywords
Low back pain, Rehabilitation, Biofeedback, Electromyography, Kinematic
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.
Interventions
OTHERBiofeedback
Idem as described in the arm section (above)
Sponsors
Université du Québec à Trois-Rivières
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flexion-relaxation Ratio | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lumbo-pelvic Range of Motion During Trunk Flexion-extension | 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. |
| Disability Level | Week 4 | Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability. |
| Pain Intensity in the Past Week | Week 2 | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). |
| Current Pain Intensity | Week 3 | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). |
| Fear of Movement Level | Week 4 | Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biofeedback Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above) | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Biofeedback |
|---|---|
| Age, Continuous | 36.52 years STANDARD_DEVIATION 11.81 |
| Body mass index, mean (SD) | 22.55 kg/m^2 STANDARD_DEVIATION 3.86 |
| Current pain intensity | 18.24 Units on a scale |
| Disability level | 12.95 units on a scale |
| Duration of low back pain in months, mean (SD) | 88.36 months STANDARD_DEVIATION 65.26 |
| Fear of movement level | 32.76 Units on a scale |
| Pain intensity in the past week | 24.62 Units on a scale |
| Region of Enrollment Canada | 21 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofeedback | Flexion-relaxation Ratio | 0.76 ratio | Standard Deviation 0.18 |
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.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofeedback | Flexion-relaxation Ratio | 0.68 Ratio | Standard Deviation 0.24 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofeedback | Flexion-relaxation Ratio | 0.75 ratio | Standard Deviation 0.18 |
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.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biofeedback | Flexion-relaxation Ratio | 0.76 ratio | Standard Deviation 0.16 |
Secondary
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time frame: Week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Current Pain Intensity | 17.19 Units on a scale |
Secondary
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Current Pain Intensity | 19.81 Units on a scale |
Secondary
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time frame: Week 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Current Pain Intensity | 22.62 Units on a scale |
Secondary
Disability Level
Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Disability Level | 14.70 units on a scale |
Secondary
Fear of Movement Level
Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Fear of Movement Level | 29.80 units on a scale |
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.
Time frame: Week 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Pelvic range | 44.03 Degrees | Standard Deviation 9.13 |
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Lumbar range | 45.15 Degrees | Standard Deviation 9.66 |
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.
Time frame: Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Pelvic range | 47.21 Degrees | Standard Deviation 9.43 |
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Lumbar range | 47.89 Degrees | Standard Deviation 9.16 |
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.
Time frame: Week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Pelvic range | 44.45 Degrees | Standard Deviation 8.26 |
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Lumbar range | 48.60 Degrees | Standard Deviation 11.64 |
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.
Time frame: Week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Pelvic range | 47.38 Degrees | Standard Deviation 9.15 |
| Biofeedback | Lumbo-pelvic Range of Motion During Trunk Flexion-extension | Lumbar range | 47.83 Degrees | Standard Deviation 10.42 |
Secondary
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time frame: Week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Pain Intensity in the Past Week | 22.90 Units on a scale |
Secondary
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Pain Intensity in the Past Week | 23.62 Units on a scale |
Secondary
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Time frame: Week 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofeedback | Pain Intensity in the Past Week | 21.48 Units on a scale |