NCT03580200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

May 25, 2018

Last Update Submit

September 25, 2019

Conditions

Keywords

Latent Trigger PointMyofascial Trigger PointTrigger Point Dry NeedlingDeep Dry NeedlingMuscle StrengthGluteus Medius

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

Study Arms (2)

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).

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).

Interventions

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.

Also known as: Deep Dry Needling
Intervention Side

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount St Joseph Univeristy

Cincinnati, Ohio, 45233, United States

Location

Related Publications (4)

  • 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.

    PMID: 2025304BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25724849BACKGROUND
  • Dommerholt J, Carel B, Franssen J. Myofascial trigger points: An evidence-informed review. Journal of Manual & Manipulative Therapy14(4): 203-221, 2006.

    BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Emily Slaven, PT, PhD, OCS

    University of Indianapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental study utilizing a pretest-posttest randomized control design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2018

First Posted

July 9, 2018

Study Start

December 17, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations