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

Not Applicable

Recruiting

• Conditions: Epicondylalgia
• Interventions: Other: Electric Dry Needling, Manual Therapy, Exercise and Ultrasound; Other: Manual Therapy, Exercise and Ultrasound

• Registration Number: NCT04609735
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Study Start: 2020-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

5. Psychiatric disorders or cognitively impaired 7. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Electric DN, Manual therapy, exercise and US	Electric Dry Needling, Manual Therapy, Exercise and Ultrasound	Dry needling, manual therapy, exercise and ultrasound
Active comparator: Manual therapy, exercise and ultrasound	Manual Therapy, Exercise and Ultrasound	Active comparator: Manual therapy, exercise and ultrasound

Primary Outcome Measures

Name	Time	Method
Change in elbow pain intensity (NPRS)	Baseline, 1-week, 4-weeks, 3-months	Numeric Pain Rating Score. Higher scores mean greater pain

Secondary Outcome Measures

Name	Time	Method
Change in Global rating of change score	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
Change in Medication Intake (Frequency of Medication Intake in last week)	Baseline, 3-months	Frequency of medication intake in last week
Disabilities of the Arm, Shoulder and Hand	Baseline, 1-week, 4-weeks, 3-months	The DASH is measured on a 0-100 scale. Greater scores indicate increased disability.

Trial Locations

Locations (1)

Mallers and Swoverland Orthopedic PT; 🇺🇸 Fort Wayne, Indiana, United States