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

Achilles Tendinopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968614
• Other study ID #: AAMT30
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Alabama Physical Therapy & Acupuncture
• Contact: James Dunning, DPT
• Phone: 18017079056
• Email: jamesdunning[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Other:
• Electric dry needling and conventional PT
Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
• Conventional PT
Eccentric Exercise, Stretching and Manual Therapy

Locations

Country	Name	City	State
United States	Prisma Health - Research PT Specialists	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

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