Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy

NCT03968614 | Recruiting

• 1 other identifier: AAMT30
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Change in VISA-A Questionnaire

  Index of severity of Achilles tendinopathy. Lower score means greater severity of condition.

  baseline, 2 weeks, 6 weeks, 3 months

Secondary Outcomes (4)

• Change in achilles pain (NPRS) (Rating Score)

  baseline, 2 weeks, 6 weeks, 3 months

• Change in Foot and Ankle Ability Measure - ADL

  baseline, 2 weeks, 6 weeks, 3 months

• Change in Foot and Ankle Ability Measure - Sports

  baseline, 2 weeks, 6 weeks, 3 months

• GROC (ranges from -7 to +7). Global Rating of Change score.

  2 weeks, 6 weeks, 3 months

Study Arms (2)

Electrical Dry Needling and conventional PT

EXPERIMENTAL

Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy

Other: Electric dry needling and conventional PT

Conventional PT

ACTIVE COMPARATOR

Eccentric Exercise, Stretching and Manual Therapy

Other: Conventional PT

Interventions

Electric dry needling and conventional PT OTHER

Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy

Electrical Dry Needling and conventional PT

Conventional PT OTHER

Eccentric Exercise, Stretching and Manual Therapy

Conventional PT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Prisma Health - Research PT Specialists

Columbia, South Carolina, 29201, United States

RECRUITING

Study Officials

• James Dunning, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Dunning, DPT

CONTACT

18017079056; jamesdunning@hotmail.com

Raymond Butts, DPT PhD

CONTACT

8034223954; fellowship@spinalmanipulation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: June 10, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)