Low Back Pain, MechanicalNCT02284724
Dry Needling to the Multifidus Muscle in Subjects With Low Back Pain
A study testing Dry Needling in people with Low Back Pain, Mechanical, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
To examine for differences in contraction thickness of the transversus abdominis muscle in symptomatic subjects with mechanical lower back pain following the application of dry needling to the lumbar multifidus muscles. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 30 Jun 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age, current symptoms of mechanical low back pain or any symptoms experienced within the last 6 months, and ability to perform DCC.
- Subjects must also report they are comfortable with being 'needled', that is, they should not express a fear of needles and being needled.
- If subjects express fear of needles or being needled, they will be excluded from the study.
Who cannot join
- History of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis, anticoagulant therapy, hemophilia, lymphedema, and cancer.
- If a subject reports a fear of needles.
- History of adverse reaction to needling (or injection) in the past.
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 Subjects With Low Back Pain
To examine for differences in contraction thickness of the transversus abdominis muscle in symptomatic subjects with mechanical lower back pain following the application of dry needling to the lumbar multifidus muscles.
Read the detailed description
Consenting subjects will be pre-screened for contraindications for dry needling and whether or not they meet the criteria for low back pain. Following acceptance and prior to intervention sessions, subjects will complete a pre-participation questionnaire. This will be used to check for any needle phobia or previous adverse reactions to needling in prospective subjects and analyze potential confounding variables within the subjects participating. Once consented and accepted into the study, subjects will be taught the deep corset contraction (DCC), which is the isolated co-contraction of bilateral transversus abdominis and the deep fibers of lumbar multifidus. Following DCC training, the subject will have a real-time ultrasound transducer applied to the lateral abdominal wall in order to image the three abdominal muscle layers external oblique, internal oblique and transversus abdominis. A relaxed state measure will be taken from the ultrasound image. Subjects will then perform the DCC and a second measure of the abdominal muscles will be taken. A percentage thickness change will be calculated. Prior to treatment, subjects will have been randomly assigned to one of 2 intervention ordered groups: 1) Dry needling: subjects will be placed prone and dry needling to the bilateral multifidus muscles will be performed. Subjects will sense light pressure and their skin will be penetrated by the needle. 2) Sham needling: subjects will be placed prone and the plastic tubes which house the needles for dry needling will be pressed into the bilateral multifidus muscles.Subjects will sense light pressure, but their skin will not be penetrated. All needling and sham needling interventions will be performed under "clean needle" conditions using appropriate skin preparation and use of clean protective gloves by the PI. The needles used will be single-use disposable acupuncture-style needles which come in a plastic tube for easy insertion. Dry needling techniques are techniques that many practicing therapists use for various musculoskeletal conditions, and are also taught by the PI as part of the requirements for the Doctor of Physical Therapy degree. For this study, all needling and sham needling interventions will be performed by the PI who has over 27 years experience in such interventions. Immediately following the needling or sham needling, the real-time ultrasound will be reapplied to measure thickness of the abdominal muscles in the relaxed state and contracted state using the DCC, and percent changes will be calculated. Measurements will be collected by one of three independent researchers who will be blinded to the intervention. An average of 3 measurements will be used to calculate the percent thickness change after the treatment. In addition, the PI performing the needling will remain blinded to ultrasound measurements. Subjects will then be contacted by phone 48 hours as well as one week after the intervention was given in which they will verbally complete questionnaires regarding their degree of pain and level of disability.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Dry Needling, Sham Needling
- 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.
Dry NeedlingProcedure or surgery
Sham NeedlingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Needling | Experimental | Insertion of solid mono-filament needle into lumbar multifidus muscle at both sides of L4/5 segment Receives: Procedure: Dry Needling |
| Sham | Other | The plastic tube containing the mono-filament needle will be pressed into the skin over the lumbar multifidus muscle at both sides of L4/5 segment - without insertion through the skin Receives: Procedure: Sham Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Using real-time ultrasound imaging to measure thickness in milimeters
Measured: Immediate
Contracted thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Using real-time ultrasound imaging to measure thickness in milimeters
Measured: Immediate
Secondary outcomes (2)
Numeric Pain Rating Scale 10 point pain scale
10 point pain scale
Measured: Immediate and 48 hours later
Oswestry Disability Index
Patient reported outcome measure
Measured: 48 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start1 Nov 2014
- Primary completion30 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284724
- Sponsor's protocol ID
- 1202-4059
- Status last verified
- Oct 2018
- First submitted
- 3 Nov 2014
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. 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 Subjects With Low Back Pain
- ClinicalTrials.gov ID
- NCT02284724
- Acronym / sponsor ID
- 1202-4059
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 6 Nov 2014 (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.
To examine for differences in contraction thickness of the transversus abdominis muscle in symptomatic subjects with mechanical lower back pain following the application of dry needling to the lumbar multifidus muscles.
Detailed description
Consenting subjects will be pre-screened for contraindications for dry needling and whether or not they meet the criteria for low back pain. Following acceptance and prior to intervention sessions, subjects will complete a pre-participation questionnaire. This will be used to check for any needle phobia or previous adverse reactions to needling in prospective subjects and analyze potential confounding variables within the subjects participating. Once consented and accepted into the study, subjects will be taught the deep corset contraction (DCC), which is the isolated co-contraction of bilateral transversus abdominis and the deep fibers of lumbar multifidus. Following DCC training, the subject will have a real-time ultrasound transducer applied to the lateral abdominal wall in order to image the three abdominal muscle layers external oblique, internal oblique and transversus abdominis. A relaxed state measure will be taken from the ultrasound image. Subjects will then perform the DCC and a second measure of the abdominal muscles will be taken. A percentage thickness change will be calculated. Prior to treatment, subjects will have been randomly assigned to one of 2 intervention ordered groups: 1) Dry needling: subjects will be placed prone and dry needling to the bilateral multifidus muscles will be performed. Subjects will sense light pressure and their skin will be penetrated by the needle. 2) Sham needling: subjects will be placed prone and the plastic tubes which house the needles for dry needling will be pressed into the bilateral multifidus muscles.Subjects will sense light pressure, but their skin will not be penetrated. All needling and sham needling interventions will be performed under "clean needle" conditions using appropriate skin preparation and use of clean protective gloves by the PI. The needles used will be single-use disposable acupuncture-style needles which come in a plastic tube for easy insertion. Dry needling techniques are techniques that many practicing therapists use for various musculoskeletal conditions, and are also taught by the PI as part of the requirements for the Doctor of Physical Therapy degree. For this study, all needling and sham needling interventions will be performed by the PI who has over 27 years experience in such interventions. Immediately following the needling or sham needling, the real-time ultrasound will be reapplied to measure thickness of the abdominal muscles in the relaxed state and contracted state using the DCC, and percent changes will be calculated. Measurements will be collected by one of three independent researchers who will be blinded to the intervention. An average of 3 measurements will be used to calculate the percent thickness change after the treatment. In addition, the PI performing the needling will remain blinded to ultrasound measurements. Subjects will then be contacted by phone 48 hours as well as one week after the intervention was given in which they will verbally complete questionnaires regarding their degree of pain and level of disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needling | Experimental | Procedure: Dry NeedlingInsertion of solid mono-filament needle into lumbar multifidus muscle at both sides of L4/5 segment |
| Sham | Other | Procedure: Sham NeedlingThe plastic tube containing the mono-filament needle will be pressed into the skin over the lumbar multifidus muscle at both sides of L4/5 segment - without insertion through the skin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age, current symptoms of mechanical low back pain or any symptoms experienced within the last 6 months, and ability to perform DCC.
- Subjects must also report they are comfortable with being 'needled', that is, they should not express a fear of needles and being needled.
- If subjects express fear of needles or being needled, they will be excluded from the study.
Key exclusion criteria (3 listed)
- History of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis, anticoagulant therapy, hemophilia, lymphedema, and cancer.
- If a subject reports a fear of needles.
- History of adverse reaction to needling (or injection) in the past.
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 Needling | Procedure or surgery | Needling |
| Sham Needling | Procedure or surgery | Sham |
Primary outcome
Resting thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Time frame: Immediate
Using real-time ultrasound imaging to measure thickness in milimeters
Contracted thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters
Time frame: Immediate
Using real-time ultrasound imaging to measure thickness in milimeters
2 secondary outcomes
Numeric Pain Rating Scale 10 point pain scale
Time frame: Immediate and 48 hours later
Oswestry Disability Index
Time frame: 48 hours later
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 24 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low Back Pain, Mechanical, 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 24 Oct 2018. 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. 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?
Resting thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters (time frame: Immediate). The study lists 2 primary outcomes in all. 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 24 Oct 2018.