NCT01567566

Brief Summary

The primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of NSLBP patients and aims to investigate the additive effect of hip stabilization exercises. The investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2) will be more effective in reducing pain and disability in NSLBP patients compared to the local (segmental) stabilizer program (T1).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

March 27, 2012

Last Update Submit

March 28, 2012

Conditions

Low Back Pain, Mechanical

Keywords

home based daily exercise programlocal lumbopelvic stabilizer muscleship stabilizer musclesreal time ultrasound imaging

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity measured by a 10cm visual analogue scale

    Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention

    6 weeks

Secondary Outcomes (2)

  • Change in biomechanical variables using an eight camera motion capture system

    6 weeks

  • Change in disability score as measured by the Oswestry Disability Questionnaire

    6 weeks

Study Arms (2)

Local lumbopelvic stabilizers

ACTIVE COMPARATOR
Other: exercise rehabilitation program

Local lumbopelvic plus hip stabilizers

EXPERIMENTAL
Other: exercise rehabilitation program

Interventions

exercise rehabilitation programOTHER

6 week home based exercise rehabilitation program with 6 weekly supervised sessions using real time ultrasound as biofeedback to augment training in both treatment arms

Also known as: Core stabilization exercises, Hip stabilization exercises
Local lumbopelvic plus hip stabilizersLocal lumbopelvic stabilizers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Unilateral or bilateral NSLBP symptoms for a minimum of 6 weeks
  • Current symptoms rated at least a 5/10 on a scaled from 0-10

You may not qualify if:

  • Symptoms 'red flags' for underlying pathological conditions such as bowel and/or bladder problems, radicular symptoms, night pain
  • Scoliosis
  • Neurological impairment, discogenic pathology, vestibular disorder
  • Pregnancy or within 1 year of giving birth
  • Previous or ongoing complications from lower extremity injury or surgery in the past year
  • Previous surgery to the lumbar spine or hip
  • Use of any radiological interventions or injections such as prolotherapy, corticosteroid, or nerve block in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Running Injury Clinic

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karen D Kendall, MKin

    Running Injury Clinic, Faculty of Kinesiology, University of Calgary

    PRINCIPAL INVESTIGATOR

  • Reed Ferber, PhD

    Running Injury Clinic, Faculty of Kinesiology, University of Calgary

    STUDY DIRECTOR

Central Study Contacts

Jill Baxter, BSc

CONTACT

403 220 7411jbaxter@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 30, 2012

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

CA(1)