Manipulation Effects on Abdominal Muscles

Sponsor

University of Nevada, Las Vegas (Other)

Overall Status

Completed

CT.gov ID

NCT01745939

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Lumbar Manipulation Other: Sham manipulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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 Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Lumbar manipulation

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

Other: Lumbar Manipulation

Manual therapy intervention

Sham Comparator: Sham manipulation

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

Other: Sham manipulation

Manual therapy intervention

Outcome Measures

Primary Outcome Measures

Transversus abdominis thickness change [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 term follow up.

Secondary Outcome Measures

Numeric Pain Rating Scale [Baseline to immediately after the intervention (within 5 minutes)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada, Las Vegas - Department of Physical Therapy	Las Vegas	Nevada	United States	89154

Sponsors and Collaborators

University of Nevada, Las Vegas

Investigators

Study Director: Jaclyn Durant, BSc, University of Nevada, Las Vegas
Study Director: Jade Elkind, BA, University of Nevada, Las Vegas
Study Director: Shawna Bohnet, BSc, University of Nevada, Las Vegas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emilio J Puentedura, PT, DPT, PhD, Assistant Professor, University of Nevada, Las Vegas

ClinicalTrials.gov Identifier:

NCT01745939

Other Study ID Numbers:

UNLVPT-4056

First Posted:

Dec 10, 2012

Last Update Posted:

Nov 5, 2014

Last Verified:

Nov 1, 2014

Keywords provided by Emilio J Puentedura, PT, DPT, PhD, Assistant Professor, University of Nevada, Las Vegas

Back pain

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Nov 5, 2014