Achilles TendinopathyNCT03968614
Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy
A study testing Electric dry needling and conventional PT and Conventional PT in people with Achilles Tendinopathy, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial summary
The purpose of this research is to compare two different approaches for treating patients with achilles tendinopathy: eccentric exercise, stretching and manual therapy VS Electric dry needling, eccentric exercise, stretching and manual therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Electric dry needling and conventional PT and Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 1 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult >18 years old that is able to speak English.
- Report of at least 3 months of Achilles pain clinically diagnosed as Achilles tendonitis or Achilles tendinopathy
- Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for Achilles pain in the last 6 months:
- Diagnosis of noninsertional tendinopathy, defined as the following
- Subjective report of pain located 2-6 cm proximal to the insertion of Achilles tendon to the calcaneus, particularly with running or jumping
- Tenderness to palpation of the Achilles tendon while the clinician gently squeezes the tendon between the thumb and index finger in a proximal to distal direction
- Positive Arc Sign - Intratendinous swelling moves relative to the malleoli with the tendon during active dorsi/plantar Flexion
- Royal London Test - Tenderness to palpation decreases significantly or disappears with max dorsiflexion
Who cannot join
- Report of red flags to manual physical therapy to include: hypertension infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe vascular disease, malignancy, etc.
- History of previous Achilles tendon surgery, ankle arthrodesis, hind foot fracture, or leg length discrepancy of more than one half inch.
- History of arthrosis or arthritis of the ankle and/or foot.
- History of significant ankle and/or foot instability
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Muscle weakness involving a major lower extremity muscle group
Show all 11Show fewer
- Diminished lower extremity patella or Achilles tendon reflexes
- Diminished / absent sensation in any lower extremity dermatome
- Involvement in litigation or worker's compensation regarding foot pain
- Any condition that might contraindicate the use of electro-needling
- The patient is pregnant.
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, 1 recruiting
- Recruiting
Prisma Health - Research PT Specialists
Columbia, South Carolina, 29201
Kris Phillips, DPT, 803-296-2273, Kris.Phillips@prismahealth.org
About this study
Official title: Electrical Dry Needling as an Adjunct to Eccentric Exercise, Stretching and Manual Therapy for Mid-portion Achilles Tendinopathy: a Multicenter Randomized Clinical Trial
The purpose of this research is to compare two different approaches for treating patients with achilles tendinopathy: eccentric exercise, stretching and manual therapy VS Electric dry needling, eccentric exercise, stretching and manual therapy. Physical therapists commonly use all of these techniques to treat achilles tendinopathy. This study is attempting to find out if one treatment strategy is more effective than the other.
Read the detailed description
Patients with achilles tendinopathy will be randomized to receive 8-10 treatments (1-2 treatments per week) over 6 weeks (10 treatments max) of either: (1)Eccentric exercise, stretching, manual therapy and electrical dry needling or 2. eccentric exercise, stretching and manual therapy
- Conditions
- Achilles Tendinopathy
- Being tested
- Electric dry needling and conventional PT, Conventional PT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric dry needling and conventional PTOther
Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
Conventional PTOther
Eccentric Exercise, Stretching and Manual Therapy
| Study group | Role | What they receive |
|---|---|---|
| Electrical Dry Needling and conventional PT | Experimental | Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy Receives: Other: Electric dry needling and conventional PT |
| Conventional PT | Active comparator | Eccentric Exercise, Stretching and Manual Therapy Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VISA-A Questionnaire
Index of severity of Achilles tendinopathy. Lower score means greater severity of condition.
Measured: baseline, 2 weeks, 6 weeks, 3 months
Secondary outcomes (4)
Change in achilles pain (NPRS) (Rating Score)
Higher scores mean greater pain
Measured: baseline, 2 weeks, 6 weeks, 3 months
Change in Foot and Ankle Ability Measure - ADL
activities of daily living (0-84 points) 21 Item 84-point ADL Subscale
Measured: baseline, 2 weeks, 6 weeks, 3 months
Change in Foot and Ankle Ability Measure - Sports
Sports (0-32 points) 8 Item 32-point sports subscale
Measured: baseline, 2 weeks, 6 weeks, 3 months
GROC (ranges from -7 to +7). Global Rating of Change score.
Measured: 2 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start10 Jun 2019
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968614
- Sponsor's protocol ID
- AAMT30
- Status last verified
- May 2025
- First submitted
- 28 May 2019
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Dry Needling as an Adjunct to Eccentric Exercise, Stretching and Manual Therapy for Mid-portion Achilles Tendinopathy: a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03968614
- Acronym / sponsor ID
- AAMT30
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 May 2019 (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 research is to compare two different approaches for treating patients with achilles tendinopathy: eccentric exercise, stretching and manual therapy VS Electric dry needling, eccentric exercise, stretching and manual therapy. Physical therapists commonly use all of these techniques to treat achilles tendinopathy. This study is attempting to find out if one treatment strategy is more effective than the other.
Detailed description
Patients with achilles tendinopathy will be randomized to receive 8-10 treatments (1-2 treatments per week) over 6 weeks (10 treatments max) of either: (1)Eccentric exercise, stretching, manual therapy and electrical dry needling or 2. eccentric exercise, stretching and manual therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Dry Needling and conventional PT | Experimental | Other: Electric dry needling and conventional PTElectrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy |
| Conventional PT | Active comparator | Other: Conventional PTEccentric Exercise, Stretching and Manual Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult >18 years old that is able to speak English.
- Report of at least 3 months of Achilles pain clinically diagnosed as Achilles tendonitis or Achilles tendinopathy
- Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for Achilles pain in the last 6 months:
- Diagnosis of noninsertional tendinopathy, defined as the following
Key exclusion criteria (11 listed)
- Report of red flags to manual physical therapy to include: hypertension infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe vascular disease, malignancy, etc.
- History of previous Achilles tendon surgery, ankle arthrodesis, hind foot fracture, or leg length discrepancy of more than one half inch.
- History of arthrosis or arthritis of the ankle and/or foot.
- History of significant ankle and/or foot instability
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
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 |
|---|---|---|
| Electric dry needling and conventional PTElectrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy | Other | Electrical Dry Needling and conventional PT |
| Conventional PTEccentric Exercise, Stretching and Manual Therapy | Other | Conventional PT |
Primary outcome
Change in VISA-A Questionnaire
Time frame: baseline, 2 weeks, 6 weeks, 3 months
Index of severity of Achilles tendinopathy. Lower score means greater severity of condition.
4 secondary outcomes
Change in achilles pain (NPRS) (Rating Score)
Time frame: baseline, 2 weeks, 6 weeks, 3 months
Change in Foot and Ankle Ability Measure - ADL
Time frame: baseline, 2 weeks, 6 weeks, 3 months
Change in Foot and Ankle Ability Measure - Sports
Time frame: baseline, 2 weeks, 6 weeks, 3 months
GROC (ranges from -7 to +7). Global Rating of Change score.
Time frame: 2 weeks, 6 weeks, 3 months
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 18 May 2025.
- 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.
James Dunning, DPT principal investigator
American Academy of Manipulative 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 Electric dry needling and conventional PT and Conventional PT in people with Achilles Tendinopathy, run by Alabama Physical Therapy & Acupuncture 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 May 2025. 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. 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?
Contact James Dunning, DPT (18017079056, jamesdunning@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VISA-A Questionnaire (time frame: baseline, 2 weeks, 6 weeks, 3 months). 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 18 May 2025.