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

• Sponsor: Nova Southeastern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02558855
• Collaborator: DeRosa Physical Therapy (Other), University of Nevada, Las Vegas (Other)
• Enrollment: 67
• Locations: 2
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 33.5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Thrust Joint Manipulation of the Lumbar Spine; Other: Non-thrust Joint Manipulation of the Lumbar Spine	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Thrust Joint Manipulation Patients will receive thrust joint manipulation to their lumbar spine in side lying.	Other: Thrust Joint Manipulation of the Lumbar Spine
Sham Comparator: Non-thrust Joint Manipulation Patients will receive non-thrust joint manipulation, oscillations into slight rotation, without cavitation, to their lumbar spine in side lying.	Other: Non-thrust Joint Manipulation of the Lumbar Spine

Outcome Measures

Primary Outcome Measures

1. 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 follow up.

Secondary Outcome Measures

1. Oswestry Low Back Pain Questionnaire [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DeRosa Physical Therapy	Flagstaff	Arizona	United States	86001
2	University of Nevada, Las Vegas	Las Vegas	Nevada	United States	89154

Sponsors and Collaborators

• Nova Southeastern University
• DeRosa Physical Therapy
• University of Nevada, Las Vegas

Investigators

• Principal Investigator: Kelly K Fosberg, DPT, Nova Southeastern University and DeRosa Physical Therapy
• Study Chair: Joshua Cleland, PhD, Nova Southeastern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kelly Fosberg, Principal Investigator; Nova Southeastern University PhD student in Physical Therapy, Nova Southeastern University
• ClinicalTrials.gov Identifier: NCT02558855
• Other Study ID Numbers: 01151512
• First Posted: Sep 24, 2015
• Last Update Posted: Apr 12, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Kelly Fosberg, Principal Investigator; Nova Southeastern University PhD student in Physical Therapy, Nova Southeastern University: Thrust Joint Manipulation; Non-thrust Joint Manipulation; Transversus Abdominis
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Apr 12, 2016