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

NCT04609735 | Recruiting

• 1 other identifier: AAMT50
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Epicondylalgia

Outcome Measures

Primary Outcomes (1)

• Change in elbow pain intensity (NPRS)

  Numeric Pain Rating Score. Higher scores mean greater pain

  Baseline, 1-week, 4-weeks, 3-months

Secondary Outcomes (3)

• Disabilities of the Arm, Shoulder and Hand

  Baseline, 1-week, 4-weeks, 3-months

• Change in Global rating of change score

  4-weeks, 3-months

• Change in Medication Intake (Frequency of Medication Intake in last week)

  Baseline, 3-months

Study Arms (2)

Experimental: Electric DN, Manual therapy, exercise and US

EXPERIMENTAL

Dry needling, manual therapy, exercise and ultrasound

Other: Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Active comparator: Manual therapy, exercise and ultrasound

ACTIVE COMPARATOR

Active comparator: Manual therapy, exercise and ultrasound

Other: Manual Therapy, Exercise and Ultrasound

Interventions

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound OTHER

Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

Experimental: Electric DN, Manual therapy, exercise and US

Manual Therapy, Exercise and Ultrasound OTHER

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

Active comparator: Manual therapy, exercise and ultrasound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Mallers and Swoverland Orthopedic PT

Fort Wayne, Indiana, 46804, United States

RECRUITING

MeSH Terms

Interventions

Musculoskeletal Manipulations; Exercise; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• James Dunning, DPT PhD

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Dunning, DPT PhD

CONTACT

801-707-9056; jamesdunning@hotmail.com

Raymond J Butts, DPT PhD

CONTACT

803-422-3954; fellowship@spinalmanipulation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, American Academy of Manipulative Therapy

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: October 31, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)