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Completed

NCT Number: NCT02558855

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DeRosa Physical Therapy, Flagstaff, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Thrust Joint Manipulation of the Lumbar Spine

Other

Non-thrust Joint Manipulation of the Lumbar Spine

Other

Primary outcomes

  1. 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

  1. Oswestry Low Back Pain Questionnaire

    Time frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

    The score of the Oswestry Low Back Pain Questionnaire will be compared from baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

  2. Numeric Pain Rating Scale

    Time frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

    The score of the Numeric Pain Rating Scale will be compared from baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

  3. Fear-Avoidance Beliefs Questionnaire

    Time frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

    The score of the Fear-Avoidance Beliefs Questionnaire will be compared from baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

  4. Global Rating of Change

    Time frame: Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.

    The score of the Global Rating of Change will be compared from immediately post-intervention (within 5 minutes) and follow-up within 48 hours over the phone.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • DeRosa Physical Therapy
  • University of Nevada, Las Vegas

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2015
Registry last updated
Apr 12, 2016

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

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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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