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Manipulation Effects on Abdominal Muscles

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar Manipulation
Sham manipulation
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain focused on measuring Back pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nevada, Las Vegas - Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Lumbar manipulation

Sham manipulation

Arm Description

Patients will receive thrust joint manipulation to their lumbar spine in side lying

Patients will receive oscillations into slight rotation, without cavitation, in side lying

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 5, 2012
Last Updated
November 3, 2014
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT01745939
Brief Title
Manipulation Effects on Abdominal Muscles
Official Title
The Immmediate Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Subjects With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Back pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar manipulation
Arm Type
Active Comparator
Arm Description
Patients will receive thrust joint manipulation to their lumbar spine in side lying
Arm Title
Sham manipulation
Arm Type
Sham Comparator
Arm Description
Patients will receive oscillations into slight rotation, without cavitation, in side lying
Intervention Type
Other
Intervention Name(s)
Lumbar Manipulation
Intervention Description
Manual therapy intervention
Intervention Type
Other
Intervention Name(s)
Sham manipulation
Intervention Description
Manual therapy intervention
Primary Outcome Measure Information:
Title
Transversus abdominis thickness change
Description
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.
Time Frame
Baseline to immediately after the intervention (within 5 minutes)
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline to immediately after the intervention (within 5 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclyn Durant, BSc
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jade Elkind, BA
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shawna Bohnet, BSc
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Study Director
Facility Information:
Facility Name
University of Nevada, Las Vegas - Department of Physical Therapy
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

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Manipulation Effects on Abdominal Muscles

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