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Recruiting NCT03968614

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

No phase Interventional Achilles Tendinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electric dry needling and conventional PT, Conventional PT.
Who it may be relevant to
Registry conditions: Achilles Tendinopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

Interventions

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

Primary outcome measures

  • Change in VISA-A Questionnaire [Time frame: baseline, 2 weeks, 6 weeks, 3 months]
Secondary outcome measures (4)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Prisma Health - Research PT Specialists — Columbia

Identifiers

NCT: NCT03968614 · AAMT30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗