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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01745939
Other study ID # UNLVPT-4056
Secondary ID
Status Completed
Phase N/A
First received December 5, 2012
Last updated November 3, 2014
Start date November 2012
Est. completion date August 2014

Study information

Verified date November 2014
Source University of Nevada, Las Vegas
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to understand how different physical therapy interventions affect the use of certain abdominal muscles in patients with low back pain.


Description:

Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. Following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. Immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Currently receiving physical therapy treatment for back pain or back pain symptoms

- 18-70 years of age

- Able to perform the abdominal drawing in maneuver

Exclusion Criteria:

- Presence of a 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, or ankylosing spondylitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Lumbar Manipulation
Manual therapy intervention
Sham manipulation
Manual therapy intervention

Locations

Country Name City State
United States University of Nevada, Las Vegas - Department of Physical Therapy Las Vegas Nevada

Sponsors (1)

Lead Sponsor Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transversus abdominis thickness change 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 term follow up. Baseline to immediately after the intervention (within 5 minutes) No
Secondary Numeric Pain Rating Scale Rating of perceived pain 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 term follow up. Baseline to immediately after the intervention (within 5 minutes) No
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