Clinical trial NCT02087969: Triceps Surae Trigger Point Size and Muscle Extensibility
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Limited Dorsiflexion
Limited Ankle Range of Motion
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Ankle Dorsiflexion Range Of Motion
timeFrame: Baseline and 10 Minutes
measure: Change in Ankle Dorsiflexion Range of Motion
timeFrame: Baseline and 3 Days
Secondary outcomes:
measure: Change in Y-Balance Test for the Lower Quarter
timeFrame: Baseline and 20 Minutes
measure: Change in Y Balance Test for the Lower Quarter
timeFrame: Baseline and 3 Days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sports Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Chad Cook, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: