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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558855
• Other study ID #: 01151512
• Status: Completed
• Phase: N/A
• First received: September 22, 2015
• Last updated: April 10, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Thrust Joint Manipulation of the Lumbar Spine

• Non-thrust Joint Manipulation of the Lumbar Spine

Locations

Country	Name	City	State
United States	DeRosa Physical Therapy	Flagstaff	Arizona
United States	University of Nevada, Las Vegas	Las Vegas	Nevada

Sponsors (3)

Lead Sponsor	Collaborator
Nova Southeastern University	DeRosa Physical Therapy, 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 follow up.	Baseline to immediately after the intervention (within 5 minutes).	No
Secondary	Oswestry Low Back Pain Questionnaire	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.	Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.	No
Secondary	Numeric Pain Rating Scale	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.	Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.	No
Secondary	Fear-Avoidance Beliefs Questionnaire	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.	Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.	No
Secondary	Global Rating of Change	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.	Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.	No