Clinical trial NCT02558855: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Thrust Joint Manipulation
Non-thrust Joint Manipulation
Transversus Abdominis
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: DeRosa Physical Therapy
name: University of Nevada, Las Vegas
First posted: 2015-09-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Transversus Abdominis thickness change.
timeFrame: Baseline to immediately after the intervention (within 5 minutes).
Secondary outcomes:
measure: Oswestry Low Back Pain Questionnaire
timeFrame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
measure: Numeric Pain Rating Scale
timeFrame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
measure: Global Rating of Change
timeFrame: Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: DeRosa Physical Therapy
state: Arizona
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
Study officials:
affiliation: Nova Southeastern University and DeRosa Physical Therapy
name: Kelly K Fosberg, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Southeastern University
name: Joshua Cleland, PhD
role: STUDY_CHAIR
References:
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.