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OpenTrials
Completed

NCT Number: NCT02087969

Triceps Surae Trigger Point Size and Muscle Extensibility

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%.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Duke Sports Medicine

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

dry needling

Procedure

Stretching

Procedure

Primary outcomes

  1. Change of Ankle Dorsiflexion Range Of Motion

    Time frame: Baseline and 10 Minutes

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

  2. Change in Ankle Dorsiflexion Range of Motion

    Time frame: Baseline and 3 Days

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

Secondary outcomes

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

    Time frame: Baseline and 20 Minutes

    Test of balance and functional performance of lower extremities.

  2. Change in Y Balance Test for the Lower Quarter

    Time frame: Baseline and 3 Days

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Effectiveness of Dry Needling to Decrease Trigger Point Size and Increase Soft Tissue Extensibility in the Triceps Surae Muscle as Measured Via Musculoskeletal Ultrasound

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2014
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.