Trial Outcomes & Findings for Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients (NCT NCT02239289)

NCT ID: NCT02239289

Last Updated: 2015-07-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Week 1
• Results posted on: 2015-07-23

Participant Flow

Participant milestones

Measure	Biofeedback Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Age, Continuous	36.52 years STANDARD_DEVIATION 11.81 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment Canada	21 participants n=5 Participants
Body mass index, mean (SD)	22.55 kg/m^2 STANDARD_DEVIATION 3.86 • n=5 Participants
Duration of low back pain in months, mean (SD)	88.36 months STANDARD_DEVIATION 65.26 • n=5 Participants
Fear of movement level	32.76 Units on a scale n=5 Participants
Disability level	12.95 units on a scale n=5 Participants
Current pain intensity	18.24 Units on a scale n=5 Participants
Pain intensity in the past week	24.62 Units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Flexion-relaxation Ratio	0.68 Ratio Standard Deviation 0.24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Flexion-relaxation Ratio	0.76 ratio Standard Deviation 0.18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Flexion-relaxation Ratio	0.76 ratio Standard Deviation 0.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Flexion-relaxation Ratio	0.75 ratio Standard Deviation 0.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Pelvic range	44.03 Degrees Standard Deviation 9.13
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Lumbar range	45.15 Degrees Standard Deviation 9.66

SECONDARY outcome

Timeframe: Week 4

Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Disability Level	14.70 units on a scale Interval 0.0 to 44.0

SECONDARY outcome

Timeframe: Week 2

101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Pain Intensity in the Past Week	22.90 Units on a scale Interval 10.0 to 60.0

SECONDARY outcome

Timeframe: Week 3

101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Current Pain Intensity	22.62 Units on a scale Interval 0.0 to 80.0

SECONDARY outcome

Timeframe: Week 4

Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Fear of Movement Level	29.80 units on a scale Interval 0.0 to 49.0

SECONDARY outcome

Timeframe: Week 2

101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Current Pain Intensity	17.19 Units on a scale Interval 0.0 to 50.0

SECONDARY outcome

Timeframe: Week 4

101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Current Pain Intensity	19.81 Units on a scale Interval 0.0 to 80.0

SECONDARY outcome

Timeframe: Week 3

101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Pain Intensity in the Past Week	21.48 Units on a scale Interval 0.0 to 80.0

SECONDARY outcome

Timeframe: Week 4

101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Pain Intensity in the Past Week	23.62 Units on a scale Interval 5.0 to 80.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Pelvic range	44.45 Degrees Standard Deviation 8.26
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Lumbar range	48.60 Degrees Standard Deviation 11.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Pelvic range	47.38 Degrees Standard Deviation 9.15
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Lumbar range	47.83 Degrees Standard Deviation 10.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Biofeedback n=21 Participants Subjects will be provided with four sessions of supervised biofeedback training Biofeedback: Idem as described in the arm section (above)
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Pelvic range	47.21 Degrees Standard Deviation 9.43
Lumbo-pelvic Range of Motion During Trunk Flexion-extension Lumbar range	47.89 Degrees Standard Deviation 9.16

Adverse Events

Biofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martin Descarreaux

Université du Québec à Trois-Rivières

Phone: 1-819-376-5011

Email: martin.descarreaux@uqtr.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place