Dry Needling and Exercise for Mid-portion Achilles Tendinopathy (DART)
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.
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Texas
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Fort Sam Houston, Texas, Stany Zjednoczone, 78324
- CPT Jennifer Moreno Primary Care Clinic - Physical Therapy
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Pozorny komparator: 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.
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This will be used as described by Hando et al 2025, using a toothpick to simulate a needle puncture.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Victorian Institute of Sport Assessment - Achilles
Ramy czasowe: From enrollment to 12 weeks
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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.
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From enrollment to 12 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient Acceptable Symptomatic State (PASS)
Ramy czasowe: Enrollment, 6, 12 and 26 weeks
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A binary yes or no question asking if symptoms are acceptable to the individual.
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Enrollment, 6, 12 and 26 weeks
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Healthcare Utilization
Ramy czasowe: Enrollment, 6-, 12- and 26-weeks
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Participants will be queried on the healthcare resources they have used up to the time of taking this questionnaire.
Items include other interventions, medication use, and specialty referrals.
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Enrollment, 6-, 12- and 26-weeks
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Ultrasound Measurements
Ramy czasowe: Enrollment and 12-weeks
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Ultrasound images of the tendon will be taken, including thickness measurements, Doppler grading, and echogenicity (brightness) rating.
Thickness will be measured in the anterior-posterior element in the transverse plane, measured three times and averaged at the thickest visible part of the tendon.
Doppler imaging will be taken to determine the number of blood vessels present in the tendon using the Ohberg scale (rated 0-4 in increasing vascularity).
Lastly, the Continuum Model of tendinopathy will be used to grade the tendon echogenicity from 0-2, with a higher score indicating less compact and darker structure compared to healthy tendon.
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Enrollment and 12-weeks
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Heel rise test
Ramy czasowe: This test will be performed at baseline, 6- and 12-week follow-ups.
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The heel rise test is a muscular performance test.
The participant is asked to perform as many heel rises as possible on one foot at a rate of 30 repetitions per minute with full range of motion.
The test is discontinued if the participant cannot complete any more repetitions with full range of motion or if pain exceeds tolerable levels.
For the purposes of this study, a verbal pain scale score of greater than 5/10 will be utilized.
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This test will be performed at baseline, 6- and 12-week follow-ups.
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Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
Ramy czasowe: Enrollment, 6-, 12- and 26-weeks
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A comprehensive health questionnaire that covers the domains of physical function, anxiety, depression, fatigue, sleep disturbance, social participation, pain interference and pain intensity.
Items are rated from 1 to 5 on a Likert scale and scores are converted into a standardized T-score (mean of 50, standard deviation of 10).
The score is adjusted by age and gender.
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Enrollment, 6-, 12- and 26-weeks
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Victorian Institute of Sports Assessment - Achilles
Ramy czasowe: In addition to enrollment and 12-weeks (primary outcome), 6- and 26-week measures will be used as secondary outcomes.
|
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.
|
In addition to enrollment and 12-weeks (primary outcome), 6- and 26-week measures will be used as secondary outcomes.
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Benjamin Hando, DSc, PhD, Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- C.2026.031 / eIRB #990741
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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