Triceps Surae Trigger Point Size and Muscle Extensibility

NCT02087969 | Completed DMC

• 1 other identifier: Pro00052299
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Limited Dorsiflexion; Limited Ankle Range of Motion

Outcome Measures

Primary Outcomes (2)

• Change of Ankle Dorsiflexion Range Of Motion

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

  Baseline and 10 Minutes

• 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.

  Baseline and 3 Days

Secondary Outcomes (2)

• Change in Y-Balance Test for the Lower Quarter

  Baseline and 20 Minutes

• Change in Y Balance Test for the Lower Quarter

  Baseline and 3 Days

Study Arms (2)

Dry Needling

EXPERIMENTAL

Dry Needling to Triceps Surae

Procedure: Dry Needling

Stretching

EXPERIMENTAL

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

Procedure: Stretching

Interventions

Dry Needling PROCEDURE

Dry Needling

Stretching PROCEDURE

Stretching

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Years Old
• No history of ankle surgery
• No current ankle injuries

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Medicine

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Chad Cook, PhD, PT

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 14, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 15, 2017

Record last verified: 2015-03

Locations

US (1)