Clinical trial NCT03968614: 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
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendinopathy
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2019-05-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in VISA-A Questionnaire
timeFrame: baseline, 2 weeks, 6 weeks, 3 months
Secondary outcomes:
measure: Change in achilles pain (NPRS) (Rating Score)
timeFrame: baseline, 2 weeks, 6 weeks, 3 months
measure: Change in Foot and Ankle Ability Measure - ADL
timeFrame: baseline, 2 weeks, 6 weeks, 3 months
measure: Change in Foot and Ankle Ability Measure - Sports
timeFrame: baseline, 2 weeks, 6 weeks, 3 months
measure: GROC (ranges from -7 to +7). Global Rating of Change score.
timeFrame: 2 weeks, 6 weeks, 3 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prisma Health - Research PT Specialists
state: South Carolina
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT
role: PRINCIPAL_INVESTIGATOR
References: