Non-Insertional Achilles TendinopathyNCT07642583
Dry Needling and Exercise for Mid-portion Achilles Tendinopathy
A study testing Dry needling in people with Non-Insertional Achilles Tendinopathy, run by Brooke Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Non-Insertional Achilles Tendinopathy
- What is being tested?
- Dry needling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to 7 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
CPT Jennifer Moreno Primary Care Clinic - Physical Therapy
Fort Sam Houston, Texas, 78324
About this study
Official title: 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.
Read more
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.
Read the 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:
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.
- Conditions
- Non-Insertional Achilles Tendinopathy
- Being tested
- Dry needling, Sham dry needling
- Keywords
- dry needling, tendon needling, heavy slow resistance training, non-insertional Achilles tendinopathy, Midportion Achilles tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
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 needlingOther
This will be used as described by Hando et al 2025, using a toothpick to simulate a needle puncture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 weeks
Secondary outcomes (6)
Patient Acceptable Symptomatic State (PASS)
A binary yes or no question asking if symptoms are acceptable to the individual.
Measured: Enrollment, 6, 12 and 26 weeks
Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
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.
Measured: Enrollment, 6-, 12- and 26-weeks
Healthcare Utilization
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.
Measured: Enrollment, 6-, 12- and 26-weeks
Victorian Institute of Sports 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.
Measured: In addition to enrollment and 12-weeks (primary outcome), 6- and 26-week measures will be used as secondary outcomes.
Ultrasound Measurements
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.
Measured: Enrollment and 12-weeks
Heel rise test
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.
Measured: This test will be performed at baseline, 6- and 12-week follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start2 Jun 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Sean Boulanger, Brooke Army Medical Center
- Investigators
- Benjamin Hando, DSc, PhD, Study chair, Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642583
- Sponsor's protocol ID
- C.2026.031 / eIRB #990741
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07642583
- Acronym / sponsor ID
- C.2026.031 / eIRB #990741
- Conditions
- Non-Insertional Achilles Tendinopathy
- Keywords
- dry needling, tendon needling, heavy slow resistance training, non-insertional Achilles tendinopathy, Midportion Achilles tendinopathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Other: Dry needlingThis 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 Needling Group | Sham comparator | Other: Sham dry needlingThis 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Score > 80 on VISA-A
- Prior Achilles rupture or surgery
- Pain reported in Achilles insertion to calcaneus only
- Needle phobia
- Self-reported pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingDry 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. | Other | Dry Needling Group |
| Sham dry needlingThis will be used as described by Hando et al 2025, using a toothpick to simulate a needle puncture. | Other | Sham Needling Group |
Primary outcome
Victorian Institute of Sport Assessment - Achilles
Time frame: From enrollment to 12 weeks
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.
6 secondary outcomes
Patient Acceptable Symptomatic State (PASS)
Time frame: Enrollment, 6, 12 and 26 weeks
Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
Time frame: Enrollment, 6-, 12- and 26-weeks
Healthcare Utilization
Time frame: Enrollment, 6-, 12- and 26-weeks
Victorian Institute of Sports Assessment - Achilles
Time frame: In addition to enrollment and 12-weeks (primary outcome), 6- and 26-week measures will be used as secondary outcomes.
Ultrasound Measurements
Time frame: Enrollment and 12-weeks
Heel rise test
Time frame: This test will be performed at baseline, 6- and 12-week follow-ups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Hando, DSc, PhD study chair
Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Non-Insertional Achilles Tendinopathy, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sport Assessment - Achilles (time frame: From enrollment to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.