Low Back PainNCT01745939
Manipulation Effects on Abdominal Muscles
A study testing Lumbar Manipulation in people with Low Back Pain, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently receiving physical therapy treatment for back pain or back pain symptoms
- 18-70 years of age
- Able to perform the abdominal drawing in maneuver
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada, Las Vegas - Department of Physical Therapy
Las Vegas, Nevada, 89154
About this study
Official title: The Immmediate Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Subjects With Low Back Pain
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.
Read the detailed description
Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. Following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. Immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.
- Conditions
- Low Back Pain
- Being tested
- Lumbar Manipulation, Sham manipulation
- Keywords
- Back pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar ManipulationOther
Manual therapy intervention
Sham manipulationOther
Manual therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Lumbar manipulation | Active comparator | Patients will receive thrust joint manipulation to their lumbar spine in side lying Receives: Other: Lumbar Manipulation |
| Sham manipulation | Sham comparator | Patients will receive oscillations into slight rotation, without cavitation, in side lying Receives: Other: Sham manipulation |
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 term follow up.
Measured: Baseline to immediately after the intervention (within 5 minutes)
Secondary outcomes (1)
Numeric Pain Rating Scale
Rating of perceived pain 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.
Measured: Baseline to immediately after the intervention (within 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
- Investigators
- Jaclyn Durant, BSc, Study director, University of Nevada, Las VegasJade Elkind, BA, Study director, University of Nevada, Las VegasShawna Bohnet, BSc, Study director, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745939
- Sponsor's protocol ID
- UNLVPT-4056
- Status last verified
- Nov 2014
- First submitted
- 5 Dec 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immmediate Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Subjects With Low Back Pain
- ClinicalTrials.gov ID
- NCT01745939
- Acronym / sponsor ID
- UNLVPT-4056
- Conditions
- Low Back Pain
- Keywords
- Back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Dec 2012 (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 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.
Detailed description
Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. Following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. Immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar manipulation | Active comparator | Other: Lumbar ManipulationPatients will receive thrust joint manipulation to their lumbar spine in side lying |
| Sham manipulation | Sham comparator | Other: Sham manipulationPatients will receive oscillations into slight rotation, without cavitation, in side lying |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently receiving physical therapy treatment for back pain or back pain symptoms
- 18-70 years of age
- Able to perform the abdominal drawing in maneuver
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Lumbar ManipulationManual therapy intervention | Other | Lumbar manipulation |
| Sham manipulationManual therapy intervention | Other | Sham 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 term follow up.
1 secondary outcome
Numeric Pain Rating Scale
Time frame: Baseline to immediately after the intervention (within 5 minutes)
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 5 Nov 2014.
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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.
Jaclyn Durant, BSc study director
University of Nevada, Las Vegas
Jade Elkind, BA study director
University of Nevada, Las Vegas
Shawna Bohnet, BSc study director
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Manipulation in people with Low Back Pain, run by University of Nevada, Las Vegas at 1 site in United States.
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 3 inclusion and 3 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 5 Nov 2014.