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Completed

NCT Number: NCT02239289

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

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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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Mechanical Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback

Other

Idem as described in the arm section (above)

Primary outcomes

  1. Flexion-relaxation Ratio

    Time frame: 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.

  2. Flexion-relaxation Ratio

    Time frame: 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.

  3. Flexion-relaxation Ratio

    Time frame: 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.

  4. Flexion-relaxation Ratio

    Time frame: 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.

Secondary outcomes

  1. Lumbo-pelvic Range of Motion During Trunk Flexion-extension

    Time frame: 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.

  2. Disability Level

    Time frame: Week 4

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

  3. Pain Intensity in the Past Week

    Time frame: Week 2

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

  4. Current Pain Intensity

    Time frame: Week 3

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

  5. Fear of Movement Level

    Time frame: Week 4

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

  6. Current Pain Intensity

    Time frame: Week 2

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

  7. Current Pain Intensity

    Time frame: Week 4

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

  8. Pain Intensity in the Past Week

    Time frame: Week 3

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

  9. Pain Intensity in the Past Week

    Time frame: Week 4

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

  10. Lumbo-pelvic Range of Motion During Trunk Flexion-extension

    Time frame: 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.

  11. Lumbo-pelvic Range of Motion During Trunk Flexion-extension

    Time frame: 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.

  12. Lumbo-pelvic Range of Motion During Trunk Flexion-extension

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2014
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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