NCT02239289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

September 4, 2014

Results QC Date

May 26, 2015

Last Update Submit

July 10, 2015

Conditions

Keywords

Low back painRehabilitationBiofeedbackElectromyographyKinematic

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (12)

  • Lumbo-pelvic Range of Motion During Trunk Flexion-extension

    Week 1

  • Disability Level

    Week 4

  • Pain Intensity in the Past Week

    Week 2

  • Current Pain Intensity

    Week 3

  • Fear of Movement Level

    Week 4

  • +7 more secondary outcomes

Study Arms (1)

Biofeedback

EXPERIMENTAL

Subjects will be provided with four sessions of supervised biofeedback training

Other: Biofeedback

Interventions

Idem as described in the arm section (above)

Biofeedback

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18 and 60 years of age.
  • Presence of non-specific chronic low back pain.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

Related Publications (4)

  • Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.

    PMID: 23777436BACKGROUND
  • 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.

    PMID: 22477926BACKGROUND
  • 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.

    PMID: 21306915BACKGROUND
  • 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.

    PMID: 17174584BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Results Point of Contact

Title
Martin Descarreaux
Organization
Université du Québec à Trois-Rivières

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 12, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

July 23, 2015

Results First Posted

July 23, 2015

Record last verified: 2015-07

Locations