Dry Needling and Exercise for Mid-portion Achilles Tendinopathy

NCT07642583 | Enrolling By Invitation DMC

• 1 other identifier: C.2026.031 / eIRB #990741
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Insertional Achilles Tendinopathy

Keywords

dry needling; tendon needling; heavy slow resistance training; non-insertional Achilles tendinopathy; Midportion Achilles tendinopathy

Outcome Measures

Primary Outcomes (1)

• Victorian Institute of Sport Assessment - Achilles

  The Victorian Institute of Sport Assessment - Achilles (VISA-A) is a questionnaire that is validated to measure pain, function and activity for people affected by Achilles tendon pain. It is rated 0-100, with increasing function at higher scores.

  From enrollment to 12 weeks

Secondary Outcomes (6)

• Patient Acceptable Symptomatic State (PASS)

  Enrollment, 6, 12 and 26 weeks

• Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)

  Enrollment, 6-, 12- and 26-weeks

• Healthcare Utilization

  Enrollment, 6-, 12- and 26-weeks

• Victorian Institute of Sports Assessment - Achilles

  In addition to enrollment and 12-weeks (primary outcome), 6- and 26-week measures will be used as secondary outcomes.

• Ultrasound Measurements

  Enrollment and 12-weeks

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

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.

Other: Dry needling

Sham Needling Group

SHAM COMPARATOR

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.

Other: Sham dry needling

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.

Dry Needling Group

Sham dry needling OTHER

This will be used as described by Hando et al 2025, using a toothpick to simulate a needle puncture.

Sham Needling Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

CPT Jennifer Moreno Primary Care Clinic - Physical Therapy

Fort Sam Houston, Texas, 78324, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Benjamin Hando, DSc, PhD

  Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group will receive sham dry needling and will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 7, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)