Trigger PointNCT03580200
Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature
A study testing Trigger Point Dry Needling in people with Trigger Point and Muscle Weakness, run by Emily Slaven, PT, PhD at 1 site in United States.
Trial summary
The purpose of this study will be to assess the effect that the application of deep trigger point dry needling to latent trigger points has on strength measurements. Specifically, the effect of deep trigger point dry needling on the strength measurements of the gluteus medius musculature immediately following… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point, Muscle Weakness
- What is being tested?
- Trigger Point Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 31 May 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females will be included in the study if they are between the ages of 18 and 50 years and are currently asymptomatic at the time of screening and data collection. Asymptomatic will be defined as individuals who are currently experiencing no pain in their lumbar spine, sacroiliac region, pelvis, or bilateral lower extremities while at rest or with activity.
Who cannot join
- Participants will be excluded from the study if they have one of the following:
- Currently pregnant as self-reported by the participant
- Pain intensity greater than 0 out of 10 on the visual analogue scale in the lumbar spine, sacroiliac region, pelvis, and bilateral lower extremities at rest or with activity
- Positive Flexion Adduction Internal Rotation (FADIR) test on either the left or right hip. If the individual experiences a reproduction of his or her pain response with the FADIR test, which is overpressure into hip flexion, adduction, and internal rotation, he or she will be excluded from participation in the study
- Present with signs and symptoms consistent with hip osteoarthritis during clinical screening using the criteria proposed Altman et al. (1991) on either the left or right hip. Criteria is as follows: If an individual presents with pain in the hip joint with hip internal rotation that is measured to be less than 15 degrees as well as hip flexion that is measured to be less than or equal to 115 degrees, they will be excluded from participation in the study.
- Diagnosed with a progressive neurological disorder that may affect the strength of their lower extremities, a chronic pain condition such as fibromyalgia or myofascial pain syndrome, a connective tissue disorder such as Ehlers-Danlos syndrome, or osteoarthritis of the hip joint
- History of hip dysplasia or Legg Calve Perthes disease
- In order to continue within the study once the inclusion criteria has been met. Participants will be required to have at least 2 palpable latent trigger points in the gluteus medius muscle on the intervention sides. Individuals that do not have greater than 2 latent trigger points on the intervention side will not be allowed to continue with the study. Data already collected for these participants will be destroyed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will be to assess the effect that the application of deep trigger point dry needling to latent trigger points has on strength measurements. Specifically, the effect of deep trigger point dry needling on the strength measurements of the gluteus medius musculature immediately following intervention will be investigated. The author hypothesizes that there will be a significant difference in strength measurements of the gluteus medius musculature between the intervention and controls sides as well as within the intervention and control sides prior to and immediately following the application of deep trigger point dry needling. It is the authors' intention that clinicians may be able to apply the results of this study to generate a safe and effective treatment plan that can reduce the risk for trunk and lower extremity injuries within their patient population by reducing the number of latent trigger points within muscle tissue.
- Conditions
- Trigger Point, Muscle Weakness
- Being tested
- Trigger Point Dry Needling
- Keywords
- Latent Trigger Point, Myofascial Trigger Point, Trigger Point Dry Needling, Deep Dry Needling, Muscle Strength, Gluteus Medius
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger Point Dry NeedlingOther
Also called Deep Dry Needling
For the purposes of this study, the term trigger point dry needling will be used to describe deep dry needling of muscle tissue. The goal of trigger point dry needling is to eliminate myofascial trigger points within muscle tissue, thereby reducing pain as well as improving motor control and function (Caramagno et al., 2015; Dommerholt et al., 2006; Shah et al., 2015). Trigger point dry needling utilizes a solid filiform needle and focuses on the penetration of a palpable myofascial trigger point at various depths. The needle is then manipulated within the tissue in an attempt to elicit a localized twitch response. Once the localized twitch response has ended, the needle is removed and another myofascial trigger point is located.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Side | Experimental | Each participant is to be randomly assigned an intervention side (side of the body that will receive trigger point dry needling) and a control side (side of the body that will not receive trigger point dry needling). Receives: Other: Trigger Point Dry Needling |
| Control Side | No intervention | Each participant is to be randomly assigned an intervention side (side of the body that will receive trigger point dry needling) and a control side (side of the body that will not receive trigger point dry needling). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by a Hand Held Dynamometer
Strength of the gluteus medius musculature will be assessed for both the control and intervention sides. Strength of the gluteus medius muscle will be assessed using a hand held dynamometer which will measure peak force in kilograms. A maximal volitional isometric contraction break test will be used with the hip in two separate positions. A total of three measurements will be taken for each position and these measurements will be averaged for the hand held dynamometer readings. Both within group and between group differences in strength measurements will be compared for significance.
Measured: Strength measurements of the gluteus medius will be recorded prior to and immediately following the application of trigger point dry needling for both the control & intervention sides to determine if a significant change in muscle strength has occurred.
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by Surface Electromyography
Strength of the gluteus medius musculature will be assessed for both the control and intervention sides. Strength of the gluteus medius muscle will be assessed using surface electromyography readings which will measure peak muscle contraction in millivolts. A maximal volitional isometric contraction break test will be used with the hip in two separate positions. A total of three measurements will be taken for each position and these measurements will be averaged for the surface electromyography readings. Both within group and between group differences in strength measurements will be compared for significance.
Measured: Strength measurements of the gluteus medius will be recorded prior to & immediately following the application of trigger point dry needling for both the control and intervention sides to determine if a significant change in muscle strength has occurred.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start17 Dec 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trigger PointStudies 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
- Single group
- Model description
- Quasi-experimental study utilizing a pretest-posttest randomized control design
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emily Slaven, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Mount St Joseph University
- Responsible party
- Sponsor-investigator, Emily Slaven, PT, PhD, University of Indianapolis
- Investigators
- Emily Slaven, PT, PhD, OCS, Principal investigator, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580200
- Sponsor's protocol ID
- 0897-MSJU
- Status last verified
- Sep 2019
- First submitted
- 25 May 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.
PubMed 2025304Caramagno J, Adrian L, Mueller L, Purl J. Analysis of competencies for dry needling by physical therapists: Final report. Federation of State Boards of Physical Therapy. https://www.apta.org/uploadedFiles/APTAorg/Advocacy/State/Issues/Dry_Needling/AnalysisCompetenciesforDryNeedlingbyPT.pdf. Published July 2015. Accessed May 21, 2018.
Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
PubMed 25724849Dommerholt J, Carel B, Franssen J. Myofascial trigger points: An evidence-informed review. Journal of Manual & Manipulative Therapy14(4): 203-221, 2006.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature
- ClinicalTrials.gov ID
- NCT03580200
- Acronym / sponsor ID
- 0897-MSJU
- Conditions
- Trigger Point, Muscle Weakness
- Keywords
- Latent Trigger Point, Myofascial Trigger Point, Trigger Point Dry Needling, Deep Dry Needling, Muscle Strength, Gluteus Medius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emily Slaven, PT, PhDUniversity, hospital or other
- Collaborators
- Mount St Joseph University
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 9 Jul 2018 (actual)
- 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 will be to assess the effect that the application of deep trigger point dry needling to latent trigger points has on strength measurements. Specifically, the effect of deep trigger point dry needling on the strength measurements of the gluteus medius musculature immediately following intervention will be investigated. The author hypothesizes that there will be a significant difference in strength measurements of the gluteus medius musculature between the intervention and controls sides as well as within the intervention and control sides prior to and immediately following the application of deep trigger point dry needling. It is the authors' intention that clinicians may be able to apply the results of this study to generate a safe and effective treatment plan that can reduce the risk for trunk and lower extremity injuries within their patient population by reducing the number of latent trigger points within muscle tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study utilizing a pretest-posttest randomized control design
| Arm | Type | Receives |
|---|---|---|
| Intervention Side | Experimental | Other: Trigger Point Dry NeedlingEach participant is to be randomly assigned an intervention side (side of the body that will receive trigger point dry needling) and a control side (side of the body that will not receive trigger point dry needling). |
| Control Side | No intervention | –Each participant is to be randomly assigned an intervention side (side of the body that will receive trigger point dry needling) and a control side (side of the body that will not receive trigger point dry needling). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females will be included in the study if they are between the ages of 18 and 50 years and are currently asymptomatic at the time of screening and data collection. Asymptomatic will be defined as individuals who are currently experiencing no pain in their lumbar spine, sacroiliac region, pelvis, or bilateral lower extremities while at rest or with activity.
Key exclusion criteria (8 listed)
- Currently pregnant as self-reported by the participant
- Pain intensity greater than 0 out of 10 on the visual analogue scale in the lumbar spine, sacroiliac region, pelvis, and bilateral lower extremities at rest or with activity
- Positive Flexion Adduction Internal Rotation (FADIR) test on either the left or right hip. If the individual experiences a reproduction of his or her pain response with the FADIR test, which is overpressure into hip flexion, adduction, and internal rotation, he or she will be excluded from participation in the study
- Present with signs and symptoms consistent with hip osteoarthritis during clinical screening using the criteria proposed Altman et al. (1991) on either the left or right hip. Criteria is as follows: If an individual presents with pain in the hip joint with hip internal rotation that is measured to be less than 15 degrees as well as hip flexion that is measured to be less than or equal to 115 degrees, they will be excluded from participation in the study.
- Diagnosed with a progressive neurological disorder that may affect the strength of their lower extremities, a chronic pain condition such as fibromyalgia or myofascial pain syndrome, a connective tissue disorder such as Ehlers-Danlos syndrome, or osteoarthritis of the hip joint
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 |
|---|---|---|
| Trigger Point Dry NeedlingAlso: Deep Dry NeedlingFor the purposes of this study, the term trigger point dry needling will be used to describe deep dry needling of muscle tissue. The goal of trigger point dry needling is to eliminate myofascial trigger points within muscle tissue, thereby reducing pain as well as improving motor control and function (Caramagno et al., 2015; Dommerholt et al., 2006; Shah et al., 2015). Trigger point dry needling utilizes a solid filiform needle and focuses on the penetration of a palpable myofascial trigger point at various depths. The needle is then manipulated within the tissue in an attempt to elicit a localized twitch response. Once the localized twitch response has ended, the needle is removed and another myofascial trigger point is located. | Other | Intervention Side |
Primary outcome
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by a Hand Held Dynamometer
Time frame: Strength measurements of the gluteus medius will be recorded prior to and immediately following the application of trigger point dry needling for both the control & intervention sides to determine if a significant change in muscle strength has occurred.
Strength of the gluteus medius musculature will be assessed for both the control and intervention sides. Strength of the gluteus medius muscle will be assessed using a hand held dynamometer which will measure peak force in kilograms. A maximal volitional isometric contraction break test will be used with the hip in two separate positions. A total of three measurements will be taken for each position and these measurements will be averaged for the hand held dynamometer readings. Both within group and between group differences in strength measurements will be compared for significance.
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by Surface Electromyography
Time frame: Strength measurements of the gluteus medius will be recorded prior to & immediately following the application of trigger point dry needling for both the control and intervention sides to determine if a significant change in muscle strength has occurred.
Strength of the gluteus medius musculature will be assessed for both the control and intervention sides. Strength of the gluteus medius muscle will be assessed using surface electromyography readings which will measure peak muscle contraction in millivolts. A maximal volitional isometric contraction break test will be used with the hip in two separate positions. A total of three measurements will be taken for each position and these measurements will be averaged for the surface electromyography readings. Both within group and between group differences in strength measurements will be compared for significance.
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 26 Sep 2019.
- Background: PubMed 2025304Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.
- BackgroundCaramagno J, Adrian L, Mueller L, Purl J. Analysis of competencies for dry needling by physical therapists: Final report. Federation of State Boards of Physical Therapy. https://www.apta.org/uploadedFiles/APTAorg/Advocacy/State/Issues/Dry_Needling/AnalysisCompetenciesforDryNeedlingbyPT.pdf. Published July 2015. Accessed May 21, 2018.
- Background: PubMed 25724849Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
- BackgroundDommerholt J, Carel B, Franssen J. Myofascial trigger points: An evidence-informed review. Journal of Manual & Manipulative Therapy14(4): 203-221, 2006.
- Individual participant dataSharing planned: No
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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.
Emily Slaven, PT, PhD, OCS principal investigator
University of Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger Point Dry Needling in people with Trigger Point and Muscle Weakness, run by Emily Slaven, PT, PhD 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 8 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 26 Sep 2019. 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?
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by a Hand Held Dynamometer (time frame: Strength measurements of the gluteus medius will be recorded prior to and immediately following the application of trigger point dry needling for both the control & intervention sides to determine if a significant change in muscle strength has occurred.). 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?
On the ClinicalTrials.gov record for NCT03580200, which also lists 4 linked publications.
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 26 Sep 2019.