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CompletedNCT02087969Updated Dec 15, 2017

Triceps Surae Trigger Point Size and Muscle Extensibility

An interventional study of Dry Needling and Stretching in Limited Dorsiflexion and Limited Ankle Range of Motion, sponsored by Duke University. Completed at 1 site in United States. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-15.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

The purpose of this study is to determine the effectiveness of dry needling in improving ankle range of motion and functional outcomes. There have been an increasing number of studies on dry needling as an intervention for pain but none thus far that have studied functional outcome measures of the ankle. The study will include healthy male subjects between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling of the triceps surae, triceps surae stretching only, dry needling and stretching. The subjects who receive dry needling as an intervention will have the trigger point identified and dry needling performed while under musculoskeletal ultrasound visualization. The subjects will undergo pre and post intervention testing including Lower Quarter Y-Balance test, passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion, deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days between the initial testing/intervention and follow up. These outcomes will be the primary variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion measurements are safe and pose no risk to the subject. Dry Needling has been found to be very safe and effective in the hands of physical therapists with a calculated risk of adverse events to be less than 0.04%.

02

Conditions studied

  • Limited Dorsiflexion
  • Limited Ankle Range of Motion
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • 18-30 Years Old
  • No history of ankle surgery
  • No current ankle injuries

Exclusion criteria

Exclusion Criteria:

  • hypothyroidism
  • fibromyalgia
  • connective tissue disorders
  • chronic pain
  • bleeding disorders including use of anti-coagulants
  • vitamin D and B12 deficiencies
  • active sites of cancer
  • local or systemic infections
  • local skin lesions, local lymphedema
  • peripheral vascular disease including varicose veins
  • compromised immune system
  • needle phobia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Dry Needling

    Dry Needling to Triceps Surae

    Procedure: Dry Needling

  • Experimental
    Stretching

    Subjects will be given a home exercise program of stretches which are commonly prescribed to improve ankle dorsiflexion.

    Procedure: Stretching

Interventions

  • ProcedureDry Needling
  • ProcedureStretching
06

What researchers measure

Primary outcomes

  1. Change of Ankle Dorsiflexion Range Of Motion

    Ankle range of motion measures will be record before and immediately after the intervention.

    Time frame: Baseline and 10 Minutes

  2. Change in Ankle Dorsiflexion Range of Motion

    Ankle dorsiflexion will again be measured at three days after the intervention to determine short term effectiveness of results.

    Time frame: Baseline and 3 Days

Secondary outcomes

  1. Change in Y-Balance Test for the Lower Quarter

    Test of balance and functional performance of lower extremities.

    Time frame: Baseline and 20 Minutes

  2. Change in Y Balance Test for the Lower Quarter

    Y Balance Test for the Lower Quarter will be assessed again at 3 days after the intervention to assess short term effectiveness.

    Time frame: Baseline and 3 Days

07

Study locations

1 site
  • Duke Sports Medicine
    Durham, North Carolina 27710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02087969
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Mar 14, 2014
Start date
Apr 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Dec 15, 2017

Study contacts

Chad Cook, PhD, PT
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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