NCT02824991

Brief Summary

Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with the purpose of obtaining local twitch responses (LTRs), which are highly effective in releasing MTrPs. In DN procedures the mechanisms associated with LTRs and the LTR intensities required for optimal clinical results are poorly understood, especially in relation to range of motion after intervention. Therefore, evaluating the intensity of LTRs is relevant for implementing DN in different clinical settings, such as in patients with muscular or neurological dysfunctions. One way to assess muscle contractions and LTRs is through ultrasound video analysis. The aim of this report was to evaluate the reliability of semi-automatic LTR intensities tracking during dry needling by assessing ultrasound signals with an image processing method, in addition to evaluating the relationship between LTR intensities and muscle elasticity. Method: Young males without signs or symptoms of musculoskeletal pain were included. Primary outcome measure was the LTR intensities determined by percentage change of muscle thickness. The secondary outcome measures were the muscle elasticity of medial gastrocnemius and hamstring, previous and posterior DN in both lower limbs for each subject. Three LTRs, detected by a physical therapist and ultrasound assessment, were induced by inserting a filament needle into muscle latent trigger points in medial gastrocnemius. The intensities of LTRs were measured by assessing ultrasound images using an optical flow method and through comparisons with manual detection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
Last Updated

December 1, 2023

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

June 24, 2016

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Size of local twitch responses to Dry Needling with Ultrasonomiography 30 fps

    acute effect based in Range of Interest (RoI) of deep fascia reference

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Clinimetric Tool

    through study completion, an average of 1 year

Study Arms (1)

Deep Dry Needling

EXPERIMENTAL

Deep Dry Needling (DN) with the purpose of obtaining local twitch responses (LTRs). Description: Latent MTrPs were identified in both MG using according the presence of a palpable taut band and hypersensitive spot in the palpable taut band as diagnostic criteria. The deep DN was administered by a physical therapist with three years of experience in the technique. The ultrasound video (SonoSite Titan; Sonosite, Bothell, WA, USA) was recorded at 60 frames per second captured through an external capture device from Epiphan Systems Inc. (Ottawa, Ontario, Canada). According to the perception of the physical therapist and the ultrasound assessment, the filament needle was inserted into the MTrP to achieve three LTRs. Posterior to DN application, the ROMs of the MG and HA were measured

Procedure: detection of local twitch response intensities during dry needling

Interventions

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsboth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer

You may not qualify if:

  • Participants were excluded if they presented any history of musculoskeletal pain in the last six months, pathological conditions of the vertebral column, neurological diseases, respiratory diseases, a systemic rheumatic condition, heritable connective tissue disorders, and/or any previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Antonio Cuesta-Vargas, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research PhD

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 7, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

December 1, 2023

Record last verified: 2016-06