search
Back to results

Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature

Primary Purpose

Trigger Point, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trigger Point Dry Needling
Sponsored by
Emily Slaven, PT, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point focused on measuring Latent Trigger Point, Myofascial Trigger Point, Trigger Point Dry Needling, Deep Dry Needling, Muscle Strength, Gluteus Medius

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

  • Mount St Joseph Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Side

Control Side

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2018
Last Updated
September 25, 2019
Sponsor
Emily Slaven, PT, PhD
Collaborators
Mount St Joseph University
search

1. Study Identification

Unique Protocol Identification Number
NCT03580200
Brief Title
Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature
Official Title
Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emily Slaven, PT, PhD
Collaborators
Mount St Joseph University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point, Muscle Weakness
Keywords
Latent Trigger Point, Myofascial Trigger Point, Trigger Point Dry Needling, Deep Dry Needling, Muscle Strength, Gluteus Medius

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental study utilizing a pretest-posttest randomized control design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Side
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Side
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Trigger Point Dry Needling
Other Intervention Name(s)
Deep Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by a Hand Held Dynamometer
Description
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.
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.
Title
The Degree of Change in the Strength of the Gluteus Medius Musculature Measured by Surface Electromyography
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Slaven, PT, PhD, OCS
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount St Joseph Univeristy
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2025304
Citation
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.
Results Reference
background
Citation
Caramagno 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.
Results Reference
background
PubMed Identifier
25724849
Citation
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.
Results Reference
background
Citation
Dommerholt J, Carel B, Franssen J. Myofascial trigger points: An evidence-informed review. Journal of Manual & Manipulative Therapy14(4): 203-221, 2006.
Results Reference
background

Learn more about this trial

Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature

We'll reach out to this number within 24 hrs