- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04609735
Manual Therapy, Exercise and US Vs. Manual Therapy, Exercise and US for Medial Epicondylalgia
September 1, 2023 updated by: James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
Manual Therapy, Exercise and Ultrasound Vs. Manual Therapy, Exercise, Ultrasound and Electric Dry Needling for Patients With 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.
Study Overview
Status
Recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Raymond J Butts, DPT PhD
- Phone Number: 803-422-3954
- Email: fellowship@spinalmanipulation.org
Study Contact Backup
- Name: James Dunning, DPT PhD
- Phone Number: 801-707-9056
- Email: jamesdunning@hotmail.com
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46804
- Recruiting
- Mallers and Swoverland Orthopedic PT
-
Contact:
- Ben England, DPT
- Phone Number: 740-403-9133
- Email: benjaminengland1313@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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.
6. Psychiatric disorders or cognitively impaired 7. Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Electric DN, Manual therapy, exercise and US
Dry needling, manual therapy, exercise and ultrasound
|
Electric Dry Needling, Manual Therapy, Exercise and Ultrasound
|
Active Comparator: Active comparator: Manual therapy, exercise and ultrasound
|
Electric Dry Needling, Manual Therapy, Exercise and Ultrasound vs. Manual Therapy, Exercise and Ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in elbow pain intensity (NPRS)
Time Frame: Baseline, 1-week, 4-weeks, 3-months
|
Numeric Pain Rating Score.
Higher scores mean greater pain
|
Baseline, 1-week, 4-weeks, 3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 1-week, 4-weeks, 3-months
|
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
|
4-weeks, 3-months
|
Change in Medication Intake (Frequency of Medication Intake in last week)
Time Frame: Baseline, 3-months
|
Frequency of medication intake in last week
|
Baseline, 3-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James Dunning, DPT PhD, American Academy of Manipulative Therapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2020
Primary Completion (Estimated)
March 2, 2024
Study Completion (Estimated)
March 2, 2024
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
October 30, 2020
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
September 1, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AAMT50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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