Dry Needling and Exercise for Mid-portion Achilles Tendinopathy: A Single-blind Randomized Control Trial

Part of paid clinical trials in Fort Sam Houston, Texas.

Sponsor
Brooke Army Medical Center
Study ID
NCT07642583
Status
Enrolling By Invitation

Conditions

  • Non-Insertional Achilles Tendinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Dry needling — OTHER
    Dry needling is the use of filiform needles without injectate. The needles are 0.30mm wide and far smaller than typical needles used for injection. Needle fenestration is performed and followed by needle rotation in this study.
  • Sham dry needling — OTHER
    This will be used as described by Hando et al 2025, using a toothpick to simulate a needle puncture.

Study Details

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.

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Mar 30, 2027
Completion
Jul 7, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Victorian Institute of Sport Assessment - Achilles [ Time Frame: Enrollment, to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
CPT Jennifer Moreno Primary Care Clinic - Physical TherapyFort Sam HoustonTexas78324-

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