Back PainNCT01734577
Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals
A study testing Dry needling in people with Back Pain, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine for a neurophysiological effect. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age, absence of back pain or symptoms for greater than 6 months and ability to perform DCC. Subjects must also report they are comfortable with being 'needled'.
Who cannot join
- Presence of back pain or symptoms within the last 6 months, history of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis. If a subject reports a fear of needles.
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 Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Healthy Subjects
Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine for a neurophysiological effect.
Read the detailed description
Consenting adults will be taught how to contract their abdominal muscles, and to contract transversus abdominis in particular. They will then have real time ultrasound measurements of the resting and contracted thickness of their left transversus abdominis muscle. After this, they will receive actual or sham needling to their left multifidus muscle by another researchers blinded to the real time ultrasound measurements. After needling or sham intervention is complete, the original researchers will return to re-measure transversus abdominis. They will be blind to intervention allocation.
- Conditions
- Back Pain
- Being tested
- Dry needling, Sham needling
- Keywords
- Back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Sterile monofilament needles
Sham needlingProcedure or surgery
Applicator tubes from the sterile monofilament needles
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Active comparator | Monofilament needles will be inserted into each subject's left multifidus muscle and stimulated mechanically for a local twitch response Receives: Procedure: Dry needling |
| Sham needling | Sham comparator | Monofilament tubes will be pressed into the left multifidus muscle and mechanically manipulated to give the sensation that needling is occuring. Receives: Procedure: Sham needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of transversus abdominis at rest and during contraction
Real time ultrasound measurement
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
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 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio, University of Nevada, Las Vegas
- Investigators
- Daniella Morton, BSc, Study director, University of Nevada Las Vegas Physical TherapySarah Buckingham, BSc, Study director, University of Nevada Las Vegas Physical TherapyCrystal Montoya, BSc, Study director, Univesity of Nevada Las Vegas Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734577
- Sponsor's protocol ID
- UNLVPT-4059
- Status last verified
- Jun 2013
- First submitted
- 21 Nov 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Puentedura EJ, Buckingham SJ, Morton D, Montoya C, Fernandez de Las Penas C. Immediate Changes in Resting and Contracted Thickness of Transversus Abdominis After Dry Needling of Lumbar Multifidus in Healthy Participants: A Randomized Controlled Crossover Trial. J Manipulative Physiol Ther. 2017 Oct;40(8):615-623. doi: 10.1016/j.jmpt.2017.06.013.
PubMed 29187313
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01734577
- Acronym / sponsor ID
- UNLVPT-4059
- Conditions
- Back Pain
- Keywords
- Back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Nov 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.
Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine for a neurophysiological effect.
Detailed description
Consenting adults will be taught how to contract their abdominal muscles, and to contract transversus abdominis in particular. They will then have real time ultrasound measurements of the resting and contracted thickness of their left transversus abdominis muscle. After this, they will receive actual or sham needling to their left multifidus muscle by another researchers blinded to the real time ultrasound measurements. After needling or sham intervention is complete, the original researchers will return to re-measure transversus abdominis. They will be blind to intervention allocation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Active comparator | Procedure: Dry needlingMonofilament needles will be inserted into each subject's left multifidus muscle and stimulated mechanically for a local twitch response |
| Sham needling | Sham comparator | Procedure: Sham needlingMonofilament tubes will be pressed into the left multifidus muscle and mechanically manipulated to give the sensation that needling is occuring. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age, absence of back pain or symptoms for greater than 6 months and ability to perform DCC. Subjects must also report they are comfortable with being 'needled'.
Key exclusion criteria (1 listed)
- Presence of back pain or symptoms within the last 6 months, history of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis. If a subject reports a fear of needles.
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 |
|---|---|---|
| Dry needlingSterile monofilament needles | Procedure or surgery | Dry needling |
| Sham needlingApplicator tubes from the sterile monofilament needles | Procedure or surgery | Sham needling |
Primary outcome
Thickness of transversus abdominis at rest and during contraction
Time frame: 1 day
Real time ultrasound measurement
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 19 Jun 2013.
- Derived from this study: PubMed 29187313Puentedura EJ, Buckingham SJ, Morton D, Montoya C, Fernandez de Las Penas C. Immediate Changes in Resting and Contracted Thickness of Transversus Abdominis After Dry Needling of Lumbar Multifidus in Healthy Participants: A Randomized Controlled Crossover Trial. J Manipulative Physiol Ther. 2017 Oct;40(8):615-623. doi: 10.1016/j.jmpt.2017.06.013.
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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.
Daniella Morton, BSc study director
University of Nevada Las Vegas Physical Therapy
Sarah Buckingham, BSc study director
University of Nevada Las Vegas Physical Therapy
Crystal Montoya, BSc study director
Univesity of Nevada Las Vegas Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with 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 1 inclusion and 1 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 19 Jun 2013. 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?
Thickness of transversus abdominis at rest and during contraction (time frame: 1 day). 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 NCT01734577, 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 19 Jun 2013.