Low Back PainNCT02558855

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

A study testing Thrust Joint Manipulation of the Lumbar Spine and Non-thrust Joint Manipulation of the Lumbar Spine in people with Low Back Pain, run by Nova Southeastern University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Low Back Pain
What is being tested?: Thrust Joint Manipulation of the Lumbar Spine and Non-thrust Joint Manipulation of the Lumbar Spine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 2 sitesUnited States
Study dates: Jan 2015to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

DeRosa Physical Therapy
Flagstaff, Arizona, 86001
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154

Other trials in United States

About this study

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.

Read the 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.

Conditions: Low Back Pain
Being tested: Thrust Joint Manipulation of the Lumbar Spine, Non-thrust Joint Manipulation of the Lumbar Spine
Keywords: Thrust Joint Manipulation, Non-thrust Joint Manipulation, Transversus Abdominis
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02558855
Study group	Role	What they receive
Thrust Joint Manipulation	Active comparator	Patients will receive thrust joint manipulation to their lumbar spine in side lying. Receives: 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. Receives: Other: Non-thrust Joint Manipulation of the Lumbar Spine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to immediately after the intervention (within 5 minutes).

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Nov 2015

First posted24 Sep 2015 (estimated)
Study startJan 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02558855
Sponsor's protocol ID: 01151512
Status last verified: Apr 2016
First submitted: 22 Sep 2015
Last updated: 12 Apr 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 32709514

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain
ClinicalTrials.gov ID: NCT02558855
Acronym / sponsor ID: 01151512
Conditions: Low Back Pain
Keywords: Thrust Joint Manipulation, Non-thrust Joint Manipulation, Transversus Abdominis
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Nova Southeastern UniversityUniversity, hospital or other
Collaborators: DeRosa Physical Therapy, University of Nevada, Las Vegas
Study start: Jan 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 24 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Thrust Joint Manipulation	Active comparator	Other: Thrust Joint Manipulation of the Lumbar SpinePatients will receive thrust joint manipulation to their lumbar spine in side lying.
Non-thrust Joint Manipulation	Sham comparator	Other: Non-thrust Joint Manipulation of the Lumbar SpinePatients will receive non-thrust joint manipulation, oscillations into slight rotation, without cavitation, to their lumbar spine in side lying.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thrust Joint Manipulation of the Lumbar Spine	Other	Thrust Joint Manipulation
Non-thrust Joint Manipulation of the Lumbar Spine	Other	Non-thrust Joint Manipulation

Primary outcome

Transversus Abdominis thickness change.
Time frame: Baseline to immediately after the intervention (within 5 minutes).
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.

4 secondary outcomes

Oswestry Low Back Pain Questionnaire
Time frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Numeric Pain Rating Scale
Time frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Fear-Avoidance Beliefs Questionnaire
Time frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Global Rating of Change
Time frame: Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
Derived from this study: PubMed 32709514Fosberg 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.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelly K Fosberg, DPT principal investigator

Nova Southeastern University and DeRosa Physical Therapy

Joshua Cleland, PhD study chair

Nova Southeastern University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transversus Abdominis thickness change. (time frame: Baseline to immediately after the intervention (within 5 minutes).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02558855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.