Comparing two treatment methods for elbow pain

Manual Therapy, Exercise and Ultrasound Vs. Manual Therapy, Exercise, Ultrasound and Electric Dry Needling for Patients With Medial Epicondylalgia

This study is testing whether adding electric dry needling to standard treatments for elbow pain helps people feel better more than just the standard treatments alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Alabama Physical Therapy & Acupuncture (other)
• Locations: 1 site (Fort Wayne, Indiana)
• Trial ID: NCT04609735 on ClinicalTrials.gov

What this trial studies

This research compares two treatment approaches for medial epicondylalgia, a condition causing pain in the elbow and forearm. Patients will be randomly assigned to receive either manual therapy, exercise, and ultrasound or the same treatments plus electric dry needling. Each participant will undergo a maximum of eight treatments over four weeks. The goal is to determine which treatment strategy is more effective in alleviating symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with at least six weeks of elbow and forearm pain consistent with medial epicondylalgia.

Not a fit: Patients with severe underlying health conditions or those who have received recent treatments for elbow pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from medial epicondylalgia.

How similar studies have performed: Other studies have explored similar treatment methods, but this specific comparison of electric dry needling with traditional therapies is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Adult between18 and 60 years old that is able to speak English.
2. Report of at least 6 weeks of elbow (i.e. medial epicondyle) and ventral forearm pain, consistent with medial epicondylalgia.
3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months.
4. Diagnosis of medial epicondylalgia, defined as the following:(Walz, 2010; Shin, 2019)

   1. Tenderness is elicited by palpation of the insertion of the flexor-pronator mass (5-10 mm distal and anterior to the middle aspect of the medial epicondyle)
   2. Pain is exacerbated by resisted wrist flexion and forearm pronation at an angle of 90°

Exclusion Criteria:

1. Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
2. Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture.
3. History of or presentation consistent with osteochondritis dissecans, osteoarthrosis, MCL injury (i.e. Pain with valgus stress or positive "milking test" - pulling on the thumb with the elbow in flexion and the forearm in supination), flexor-pronator strain, and ulnar neuropathy (i.e. Positive Tinel sign - distal pain and tingling during direct compression of the nerve at the elbow).
4. Report of systemic neurological disorders and/or neurological deficits to include the following: a. Nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity deep tendon reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome) b. Cervical or thoracic spinal stenosis (exhibited by bilateral upper extremity symptoms) c. Central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes) d. History of whiplash or T-spine injury injury within the previous 6 weeks 5. History of surgery to the head/neck/T-spine or affected upper extremity.

6\. Psychiatric disorders or cognitively impaired 7. Pregnancy

Where this trial is running

Fort Wayne, Indiana

• Mallers and Swoverland Orthopedic PT — Fort Wayne, Indiana, United States (RECRUITING)

Study contacts

• Principal investigator: James Dunning, DPT PhD — American Academy of Manipulative Therapy
• Study coordinator: James Dunning, DPT PhD

Conditions: Epicondylalgia