Manipulation Effects on Abdominal Muscles

Study Overview
=================
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.

Official Title
-----------------
The Immmediate Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Subjects With Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Lumbar Manipulation
* Other: Sham manipulation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumbar manipulation<br>Patients will receive thrust joint manipulation to their lumbar spine in side lying | Other: Lumbar Manipulation<br>* Manual therapy intervention<br>|
| Sham Comparator: Sham manipulation<br>Patients will receive oscillations into slight rotation, without cavitation, in side lying | Other: Sham manipulation<br>* Manual therapy intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Back pain