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Clinical Trials/NCT02558855
NCT02558855CompletedNot Applicable

The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain

Nova Southeastern University4 sites in 1 country67 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
67
Locations
4
Primary Endpoint
Transversus Abdominis thickness change.

Study Overview

Brief Summary

The primary aim of this study is to examine how different physical therapy interventions affect the resting state and contraction state of a certain abdominal muscle in patients with low back pain.

Detailed Description

Patients with low back pain (LBP) will undergo ultrasound imaging of the transversus abdominis to measure the muscle thickness at rest and at the contracted state prior to intervention and again immediately after intervention. In this randomized controlled trial, patients will be randomized into one of two groups. One group will receive the intervention of thrust joint manipulation of the lumbar spine and the other group will receive the intervention of non-thrust joint manipulation of the lumbar spine.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults between 18-70 years of age with primary symptom of LBP, with or without referral into lower extremity.
  • Subjects must be able to read and write in English.

Exclusion Criteria

  • Presence of serious pathology.
  • Diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness).
  • Any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, scoliosis, or ankylosing spondylitis.
  • Pregnancy
  • Pending legal action.
  • Prior surgery to the lumbar spine or fractures of the lumbar spine.

Outcomes

Primary Outcomes

Transversus Abdominis thickness change.

Time Frame: Baseline to immediately after the intervention (within 5 minutes).

Measurement of change in thickness from resting to contraction will be compared at baseline (pre-intervention) to immediately following the intervention (post-intervention). The study is looking at the immediate effects so there is no short-term or longer follow up.

Secondary Outcomes

  • Fear-Avoidance Beliefs Questionnaire(Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.)
  • Numeric Pain Rating Scale(Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.)
  • Oswestry Low Back Pain Questionnaire(Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.)
  • Global Rating of Change(Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kelly Fosberg

Principal Investigator; Nova Southeastern University PhD student in Physical Therapy

Nova Southeastern University

Study Sites (4)

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