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

NCT ID: NCT04609735

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2026-05-01

Brief Summary

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.

Detailed Description

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

Conditions

Epicondylalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Electric DN, Manual therapy, exercise and US

Dry needling, manual therapy, exercise and ultrasound

Group Type: EXPERIMENTAL

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Intervention Type: OTHER

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Active comparator: Manual therapy, exercise and ultrasound

Active comparator: Manual therapy, exercise and ultrasound

Group Type: ACTIVE_COMPARATOR

Manual Therapy, Exercise and Ultrasound

Intervention Type: OTHER

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

Interventions

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Intervention Type: OTHER

Manual Therapy, Exercise and Ultrasound

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Alabama Physical Therapy & Acupuncture

OTHER

Sponsor Role: lead

Responsible Party

James Dunning, DPT, MSc, FAAOMPT

Director, American Academy of Manipulative Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Dunning, DPT PhD

Role: PRINCIPAL_INVESTIGATOR

American Academy of Manipulative Therapy

Locations

Mallers and Swoverland Orthopedic PT

Fort Wayne, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James Dunning, DPT PhD

Role: CONTACT

jamesdunning@hotmail.com

801-707-9056

Raymond J Butts, DPT PhD

Role: CONTACT

fellowship@spinalmanipulation.org

803-422-3954

Facility Contacts

Ben England, DPT

Role: primary

benjaminengland1313@gmail.com

740-403-9133

Other Identifiers

AAMT50

Identifier Type: -

Identifier Source: org_study_id