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

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.

Study Overview

• Status: Recruiting
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Other: Electric dry needling and conventional PT; Other: Conventional PT

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Dunning, DPT; Phone Number: 18017079056; Email: jamesdunning@hotmail.com
• Study Contact Backup: Name: Raymond Butts, DPT PhD; Phone Number: 8034223954; Email: fellowship@spinalmanipulation.org

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Recruiting
      • Prisma Health - Research PT Specialists
      • Contact: Kris Phillips, DPT; Phone Number: 803-296-2273; Email: Kris.Phillips@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult >18 years old that is able to speak English.
2. Report of at least 3 months of Achilles pain clinically diagnosed as Achilles tendonitis or Achilles tendinopathy
3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for Achilles pain in the last 6 months:

4. 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

Exclusion Criteria:

1. 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.
2. History of previous Achilles tendon surgery, ankle arthrodesis, hind foot fracture, or leg length discrepancy of more than one half inch.
3. History of arthrosis or arthritis of the ankle and/or foot.
4. History of significant ankle and/or foot instability

5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   1. Muscle weakness involving a major lower extremity muscle group
   2. Diminished lower extremity patella or Achilles tendon reflexes
   3. Diminished / absent sensation in any lower extremity dermatome
6. Involvement in litigation or worker's compensation regarding foot pain
7. Any condition that might contraindicate the use of electro-needling
8. The patient is pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical Dry Needling and conventional PT; Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy	Other: Electric dry needling and conventional PT; Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
Active Comparator: Conventional PT; Eccentric Exercise, Stretching and Manual Therapy	Other: Conventional PT; Eccentric Exercise, Stretching and Manual Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in achilles pain (NPRS) (Rating Score)	Higher scores mean greater pain	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	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	baseline, 2 weeks, 6 weeks, 3 months
GROC (ranges from -7 to +7). Global Rating of Change score.		2 weeks, 6 weeks, 3 months

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, DPT, American Academy of Manipulative Therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: AAMT30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No