Dry Needling and Exercise for Mid-portion Achilles Tendinopathy

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:

This study will be a single-blind superiority randomized control trial with two arms. Participants will be randomly assigned to one of two groups: (1) standard physical therapy combined with ultrasound-guided tendon dry needling, or (2) standard physical therapy with sham tendon needling. Participants will be blinded to group allocation, while the treating clinician cannot be blinded due to the nature of the intervention.

Procedures:

Following informed consent, participants will complete baseline assessments including demographic data, self-report questionnaires, ultrasound imaging of the Achilles tendon, and physical performance testing. Self-report outcomes include the Victorian Institute of Sport Assessment-Achilles (VISA-A), Patient Acceptable Symptom State (PASS), and Patient-Reported Outcomes Measurement Information System(PROMIS)-29. Physical testing includes the heel-rise test and standard physical therapy evaluation. Ultrasound measures will assess tendon thickness, neovascularization (Ohberg scale), and echogenicity.

All participants will receive standard physical therapy care, to include a standardized 12-week exercise program targeting the calf-Achilles complex and standardized manual therapy techniques as clinically indicated. Exercises will be performed three times per week, with one supervised session and two home sessions. Exercise load will progress over time and be guided by pain monitoring and performance. Compliance will be tracked using exercise logs.

Participants randomized to the experimental group will receive ultrasound-guided tendon dry needling in 6 sessions over approximately 6 weeks. Multiple filiform needles will be inserted into the pathological region of the tendon (identified by ultrasound or tenderness, if no signs are present) and mechanically stimulated via rotation under ultrasound guidance. Participants in the control group will receive sham needling using the same procedure and with the same schedule, instead using a toothpick housed in a needle sheath to simulate the procedure without tissue penetration.

Outcome measures will be collected at baseline, 6 weeks, and 12 weeks, with an additional survey-based follow-up at 26 weeks. The primary outcome is the between-group difference in VISA-A score at 12 weeks. Secondary outcomes include tendon structural changes, additional patient-reported outcomes, physical performance measures, and longer-term symptom acceptability.

• Patient Acceptable Symptomatic State (PASS) [Срок оценки: Enrollment, 6, 12 and 26 weeks]
• Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) [Срок оценки: Enrollment, 6-, 12- and 26-weeks]
• Healthcare Utilization [Срок оценки: Enrollment, 6-, 12- and 26-weeks]
• Victorian Institute of Sports Assessment - Achilles [Срок оценки: In addition to enrollment and 12-weeks (primary outcome), 6- and 26-week measures will be used as secondary outcomes.]
• Ultrasound Measurements [Срок оценки: Enrollment and 12-weeks]
• Heel rise test [Срок оценки: This test will be performed at baseline, 6- and 12-week follow-ups.]