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NCT Number: NCT04609735

Manual Therapy, Exercise and US Vs. Manual Therapy, Exercise and US for Medial Epicondylalgia

The purpose of this research is to compare two different approaches for treating patients with medial epicondylalgia: manual therapy, exercise and ultrasound and manual therapy, exercise, ultrasound and electric dry needling. Physical therapists commonly use all of these techniques to treat medial epicondylalgia. This study is attempting to find out if one treatment strategy is more effective than the other.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mallers and Swoverland Orthopedic PT

Fort Wayne, Indiana, 46804, United States

Location status: Recruiting

Location contact

Ben England, DPT

CONTACT

[email protected]

740-403-9133

About this study

Patients with medial epicondylalgia will be randomized to receive 8 treatments (2 treatments per week) over 4 weeks (8 treatments max) of either: 1. manual therapy, exercise and ultrasound or 2. manual therapy, exercise, ultrasound and electric dry needling

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult between18 and 60 years old that is able to speak English.
  • Report of at least 6 weeks of elbow (i.e. medial epicondyle) and ventral forearm pain, consistent with medial epicondylalgia.
  • Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months.
  • Diagnosis of medial epicondylalgia, defined as the following:(Walz, 2010; Shin, 2019)
  • 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)
  • Pain is exacerbated by resisted wrist flexion and forearm pronation at an angle of 90°

Exclusion criteria

  • 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.
  • Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture.
  • 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).
  • 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.
  • Psychiatric disorders or cognitively impaired 7. Pregnancy

Treatment and study plan

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Other

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Manual Therapy, Exercise and Ultrasound

Other

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound vs. Manual Therapy, Exercise and Ultrasound

Primary outcomes

  1. Change in elbow pain intensity (NPRS)

    Time frame: Baseline, 1-week, 4-weeks, 3-months

    Numeric Pain Rating Score. Higher scores mean greater pain

Secondary outcomes

  1. Disabilities of the Arm, Shoulder and Hand

    Time frame: Baseline, 1-week, 4-weeks, 3-months

    The DASH is measured on a 0-100 scale. Greater scores indicate increased disability.

  2. Change in Global rating of change score

    Time frame: 4-weeks, 3-months

    Global rating of change - Scale = -7 to 7. Greater numbers represent a perceived improvement of symptoms, while lesser scores indicate a perceived worsening of symptoms

  3. Change in Medication Intake (Frequency of Medication Intake in last week)

    Time frame: Baseline, 3-months

    Frequency of medication intake in last week

Study contacts

Contact information is provided by the study sponsor or research team.

James Dunning, DPT PhD

CONTACT

[email protected]

801-707-9056

Raymond J Butts, DPT PhD

CONTACT

[email protected]

803-422-3954

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2020
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.