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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrust Joint Manipulation of the Lumbar Spine
Non-thrust Joint Manipulation of the Lumbar Spine
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Thrust Joint Manipulation, Non-thrust Joint Manipulation, Transversus Abdominis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • DeRosa Physical Therapy
  • University of Nevada, Las Vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Thrust Joint Manipulation

Non-thrust Joint Manipulation

Arm Description

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

Patients will receive non-thrust joint manipulation, oscillations into slight rotation, without cavitation, to their lumbar spine 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 follow up.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 22, 2015
Last Updated
April 10, 2016
Sponsor
Nova Southeastern University
Collaborators
DeRosa Physical Therapy, University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT02558855
Brief Title
The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain
Official Title
The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University
Collaborators
DeRosa Physical Therapy, University of Nevada, Las Vegas

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Thrust Joint Manipulation, Non-thrust Joint Manipulation, Transversus Abdominis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrust Joint Manipulation
Arm Type
Active Comparator
Arm Description
Patients will receive thrust joint manipulation to their lumbar spine in side lying.
Arm Title
Non-thrust Joint Manipulation
Arm Type
Sham Comparator
Arm Description
Patients will receive non-thrust joint manipulation, oscillations into slight rotation, without cavitation, to their lumbar spine in side lying.
Intervention Type
Other
Intervention Name(s)
Thrust Joint Manipulation of the Lumbar Spine
Intervention Type
Other
Intervention Name(s)
Non-thrust Joint Manipulation of the Lumbar Spine
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 follow up.
Time Frame
Baseline to immediately after the intervention (within 5 minutes).
Secondary Outcome Measure Information:
Title
Oswestry Low Back Pain Questionnaire
Description
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.
Time Frame
Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Title
Fear-Avoidance Beliefs Questionnaire
Description
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.
Time Frame
Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Title
Global Rating of Change
Description
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.
Time Frame
Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly K Fosberg, DPT
Organizational Affiliation
Nova Southeastern University and DeRosa Physical Therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Cleland, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Study Chair
Facility Information:
Facility Name
DeRosa Physical Therapy
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
University of Nevada, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32709514
Citation
Fosberg KK, Puentedura E, Schmitz B, Jain TK, Cleland JA. The Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Patients With Low Back Pain: A Randomized Control Trial. J Manipulative Physiol Ther. 2020 May;43(4):339-355. doi: 10.1016/j.jmpt.2019.04.006. Epub 2020 Jul 21.
Results Reference
derived

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

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