The Effect of Adding Ultrasound-guided Tendon Dry Needling to a Program of Heavy, Slow Loading Exercise for Individuals With Non-insertional Achilles Tendinopathy: A Single-blind Randomized Control Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Brooke Army Medical Center
- Enrollment
- 74
- Locations
- 1
Study Overview
Brief Summary
The purpose of this study is to determine if adding ultrasound-guided tendon dry needling with mechanical needle stimulation to a standard heavy, slow resistance (HSR) exercise program improves outcomes for individuals with chronic midportion Achilles tendinopathy. Achilles tendinopathy is a common condition causing long-term pain and reduced function in the main heel tendon.
All participants in this study will engage in a standardized 12-week physical therapy exercise program targeting the calf and Achilles tendon complex. Exercises are performed three times per week, combining supervised clinic sessions and home exercises, with the workload safely progressing over time based on individual performance and pain monitoring.
In addition to the standard exercise program, participants will be randomly assigned to one of two groups to evaluate the effect of the dry needling procedure. The experimental group will receive 6 sessions of ultrasound-guided tendon dry needling over approximately 6 weeks, where fine needles are inserted into the affected area of the tendon and gently rotated under ultrasound visualization to stimulate tissue remodeling. The control group will receive an identical schedule of "sham" (placebo) needling, using a toothpick device inside a needle sheath to mimic the sensation without actually penetrating the skin.
Improvements in pain, physical function, and physical performance (such as a heel-rise endurance test) will be recorded at baseline, 6 weeks, 12 weeks, and 26 weeks. Ultrasound imaging will also be used to evaluate structural changes inside the tendon, such as thickness and blood flow. The primary objective is to compare changes in Achilles-specific pain and function scores between the two groups at the conclusion of the 12-week intervention to determine if actual dry needling provides superior therapeutic benefits compared to exercise alone.
Detailed Description
Purpose:
The purpose of this study is to determine whether adding ultrasound-guided tendon dry needling with mechanical needle stimulation to a standardized heavy, slow resistance (HSR) exercise program results in greater improvements in pain, function, and tendon structure compared to HSR exercise alone in individuals with chronic midportion (non-insertional) Achilles tendinopathy.
Subject Population:
The study will recruit 74 adult male and female Tricare beneficiaries aged 18-64 years from the Joint Base San Antonio (JBSA) area. Eligible participants must have non-acute (>6 weeks) midportion Achilles tendinopathy, defined as pain localized 2-7 cm proximal to the Achilles insertion that is provoked by loading activities such as walking, running, or jumping. Individuals with prior Achilles rupture or surgery, insertional Achilles pain only, systemic inflammatory or neurologic conditions, recent corticosteroid injections, needle phobia, pregnancy, trainee status, or other specified exclusion criteria will be excluded.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The control group will receive sham dry needling and will be blinded to the treatment.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptoms in one or both Achilles tendons
- •Pain reported in Achilles with running, jumping or walking
- •Symtom duration ≥ 6 weeks
- •Age 18-64
- •English-speaking
Exclusion Criteria
- •Score > 80 on VISA-A
- •Prior Achilles rupture or surgery
- •Pain reported in Achilles insertion to calcaneus only
- •Needle phobia
- •Self-reported pregnancy
- •Trainee status
- •Corticosteroid injection in the past 3 months into the Achilles tendon
- •Unable to participate in 12 week program
- •Taken Quinolone antibiotics past three months (e.g. Cipro, Levaquin, Floxin, Baxdela)
- •Currently undergoing separation from the military
- •Diagnosis of rheumatoid arthritis, systemic connective tissue disorder, or neurological disorder affecting the lower leg.
- •Symptoms in Achilles tendon are from another source (e.g. S1 radicular pain, referred pain, sural nerve entrapment)
- •Currently undergoing active physical therapy elsewhere for Achilles pain
Arms & Interventions
Dry Needling Group
This group will undergo a standardized calf strengthening program in addition to receiving tendon dry needling under ultrasound guidance once a week for 6 weeks. Needling will include up to 5 needle passes into every centimeter of the tender or tendinopathic area (if visible on ultrasound) at varying angles with at minimum two needles placed while under ultrasound guidance. The ultrasound unit will be placed in long axis to the Achilles tendon on the opposite side of the needling with an in-plane view and needle direction of 45 degrees caudally. The needles will then be rotated unilaterally until resistance is felt by the clinician or if the symptoms reach the upper limit of the participant's tolerance. This will be repeated as tolerated no less than twice in a 10-minute period, then the needles will be removed. The remainder of the session will be spent performing exercise or manual therapy as deemed necessary by the treating clinician.
Intervention: Dry needling (Other)
Sham Needling Group
This group will undergo a standardized calf strengthening program in addition to receiving sham dry needling once a week for 6 weeks. The same procedures will be used as the experimental group, with ultrasound imaging applied longitudinally opposite to the sham needling, but using a toothpick to simulate a needle. The toothpick will be applied to the skin through a needle tube and rotated for 15-30 seconds. This will be applied for every one centimeter of tender or tendinopathic tendon and repeated until ten minutes has elapsed. The remainder of the session will be spent performing exercise or manual therapy as deemed necessary by the treating clinician.
Intervention: Sham dry needling (Other)
Outcomes
Primary Outcomes
Not specified
Secondary Outcomes
- Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)(Enrollment, 6-, 12- and 26-weeks)
Investigators
Sean Boulanger
Physical Therapist
Brooke Army Medical Center