Clinical trial Recruiting at 1 site Interventional Ages 18 to 60

Comparing two treatment methods for elbow pain

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

Run by Alabama Physical Therapy & Acupuncture · NCT04609735 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment110 (estimated)
SponsorAlabama Physical Therapy & Acupuncture
Academic / other
Locations1 site (Fort Wayne, Indiana)
StatusRecruiting
StartedOctober 31, 2020
Main results expectedMay 1, 2026
Study endsMay 1, 2026
Registry record updatedMay 18, 2025
Trial IDNCT04609735 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: jamesdunning@hotmail.com
  • Phone: 801-707-9056

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Comparing treatments for cervicogenic headaches and whiplash injuries

    This study is testing whether dry needling with thrust manipulation or exercise with non-thrust mobilization works better for people with cervicogenic headaches from whiplash injuries.

    Recruiting Alabama Physical Therapy & Acupuncture · Montgomery, Alabama · NCT06502951

  • Comparing two treatment approaches for tension-type headaches

    This study is testing two different treatment methods for people with tension-type headaches to see which one helps them feel better.

    Recruiting Alabama Physical Therapy & Acupuncture · Fort Wayne, Indiana · NCT04609709

  • Comparing two treatments for Achilles tendinopathy

    This study tests which treatment works better for people with Achilles tendinopathy by comparing a combination of therapies to a simpler approach over six weeks.

    Recruiting Alabama Physical Therapy & Acupuncture · Columbia, South Carolina · NCT03968614

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.