NCT02558855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

September 22, 2015

Last Update Submit

April 10, 2016

Conditions

Low Back Pain

Keywords

Thrust Joint ManipulationNon-thrust Joint ManipulationTransversus Abdominis

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (4)

  • Oswestry Low Back Pain Questionnaire

    Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

  • Numeric Pain Rating Scale

    Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

  • Fear-Avoidance Beliefs Questionnaire

    Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.

  • Global Rating of Change

    Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.

Study Arms (2)

Thrust Joint Manipulation

ACTIVE COMPARATOR

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

Other: Thrust Joint Manipulation of the Lumbar Spine

Non-thrust Joint Manipulation

SHAM COMPARATOR

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

Interventions

Thrust Joint Manipulation of the Lumbar SpineOTHER
Thrust Joint Manipulation
Non-thrust Joint Manipulation of the Lumbar SpineOTHER
Non-thrust Joint Manipulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DeRosa Physical Therapy

Flagstaff, Arizona, 86001, United States

Location

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (1)

  • 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.

    PMID: 32709514DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly K Fosberg, DPT

    Nova Southeastern University and DeRosa Physical Therapy

    PRINCIPAL INVESTIGATOR

  • Joshua Cleland, PhD

    Nova Southeastern University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Nova Southeastern University PhD student in Physical Therapy

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations

US(2)