NCT01745939

Brief Summary

The purpose of this study is to understand how different physical therapy interventions affect the use of certain abdominal muscles 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
12

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

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

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

December 5, 2012

Last Update Submit

November 3, 2014

Conditions

Keywords

Back pain

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 term follow up.

    Baseline to immediately after the intervention (within 5 minutes)

Secondary Outcomes (1)

  • Numeric Pain Rating Scale

    Baseline to immediately after the intervention (within 5 minutes)

Study Arms (2)

Lumbar manipulation

ACTIVE COMPARATOR

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

Other: Lumbar Manipulation

Sham manipulation

SHAM COMPARATOR

Patients will receive oscillations into slight rotation, without cavitation, in side lying

Other: Sham manipulation

Interventions

Manual therapy intervention

Lumbar manipulation

Manual therapy intervention

Sham manipulation

Eligibility Criteria

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

You may qualify if:

  • Currently receiving physical therapy treatment for back pain or back pain symptoms
  • years of age
  • Able to perform the abdominal drawing in maneuver

You may not qualify if:

  • Presence of a 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, or ankylosing spondylitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Las Vegas - Department of Physical Therapy

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Jaclyn Durant, BSc

    University of Nevada, Las Vegas

    STUDY DIRECTOR
  • Jade Elkind, BA

    University of Nevada, Las Vegas

    STUDY DIRECTOR
  • Shawna Bohnet, BSc

    University of Nevada, Las Vegas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations