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

Primary Purpose

Achilles Tendinopathy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electric dry needling and conventional PT

Conventional PT

About this trial

This is an interventional treatment trial for Achilles Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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:
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
Involvement in litigation or worker's compensation regarding foot pain
Any condition that might contraindicate the use of electro-needling
The patient is pregnant.

Sites / Locations

Prisma Health - Research PT SpecialistsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical Dry Needling and conventional PT

Conventional PT

Arm Description

Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy

Eccentric Exercise, Stretching and Manual Therapy

Outcomes

Primary Outcome Measures

Change in VISA-A Questionnaire

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

Secondary Outcome Measures

Change in achilles pain (NPRS) (Rating Score)

Higher scores mean greater pain

Change in Foot and Ankle Ability Measure - ADL

activities of daily living (0-84 points) 21 Item 84-point ADL Subscale

Change in Foot and Ankle Ability Measure - Sports

Sports (0-32 points) 8 Item 32-point sports subscale

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

Full Information

NCT ID

NCT03968614

First Posted

May 28, 2019

Last Updated

September 1, 2023

Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT03968614

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 10, 2019 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achilles Tendinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electrical Dry Needling and conventional PT

Arm Type

Experimental

Arm Description

Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy

Arm Title

Conventional PT

Arm Type

Active Comparator

Arm Description

Eccentric Exercise, Stretching and Manual Therapy

Intervention Type

Other

Intervention Name(s)

Electric dry needling and conventional PT

Intervention Description

Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy

Intervention Type

Other

Intervention Name(s)

Conventional PT

Intervention Description

Eccentric Exercise, Stretching and Manual Therapy

Primary Outcome Measure Information:

Title

Change in VISA-A Questionnaire

Description

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

Time Frame

baseline, 2 weeks, 6 weeks, 3 months

Secondary Outcome Measure Information:

Title

Change in achilles pain (NPRS) (Rating Score)

Description

Higher scores mean greater pain

Time Frame

baseline, 2 weeks, 6 weeks, 3 months

Title

Change in Foot and Ankle Ability Measure - ADL

Description

activities of daily living (0-84 points) 21 Item 84-point ADL Subscale

Time Frame

baseline, 2 weeks, 6 weeks, 3 months

Title

Change in Foot and Ankle Ability Measure - Sports

Description

Sports (0-32 points) 8 Item 32-point sports subscale

Time Frame

baseline, 2 weeks, 6 weeks, 3 months

Title

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

Time Frame

2 weeks, 6 weeks, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James Dunning, DPT

Phone

18017079056

jamesdunning@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Raymond Butts, DPT PhD

Phone

8034223954

fellowship@spinalmanipulation.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Dunning, DPT

Organizational Affiliation

American Academy of Manipulative Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prisma Health - Research PT Specialists

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kris Phillips, DPT

Phone

803-296-2273

Kris.Phillips@prismahealth.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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