EpicondylalgiaNCT04609735
Manual Therapy, Exercise and US Vs. Manual Therapy, Exercise and US for Medial Epicondylalgia
A study testing Electric Dry Needling, Manual Therapy, Exercise and Ultrasound and Manual Therapy, Exercise and Ultrasound in people with Epicondylalgia, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epicondylalgia
- What is being tested?
- Electric Dry Needling, Manual Therapy, Exercise and Ultrasound and Manual Therapy, Exercise and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2020to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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°
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mallers and Swoverland Orthopedic PT
Fort Wayne, Indiana, 46804
Ben England, DPT, 740-403-9133, benjaminengland1313@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Electric Dry Needling, Manual Therapy, Exercise and Ultrasound, Manual Therapy, Exercise and Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric Dry Needling, Manual Therapy, Exercise and UltrasoundOther
Electric Dry Needling, Manual Therapy, Exercise and Ultrasound
Manual Therapy, Exercise and UltrasoundOther
Electric Dry Needling, Manual Therapy, Exercise and Ultrasound vs. Manual Therapy, Exercise and Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Electric DN, Manual therapy, exercise and US | Experimental | Dry needling, manual therapy, exercise and ultrasound Receives: 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 Receives: Other: Manual Therapy, Exercise and Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in elbow pain intensity (NPRS)
Numeric Pain Rating Score. Higher scores mean greater pain
Measured: Baseline, 1-week, 4-weeks, 3-months
Secondary outcomes (3)
Disabilities of the Arm, Shoulder and Hand
The DASH is measured on a 0-100 scale. Greater scores indicate increased disability.
Measured: Baseline, 1-week, 4-weeks, 3-months
Change in Global rating of change score
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
Measured: 4-weeks, 3-months
Change in Medication Intake (Frequency of Medication Intake in last week)
Frequency of medication intake in last week
Measured: Baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start31 Oct 2020
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpicondylalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT PhD, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609735
- Sponsor's protocol ID
- AAMT50
- Status last verified
- May 2025
- First submitted
- 26 Oct 2020
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy, Exercise and Ultrasound Vs. Manual Therapy, Exercise, Ultrasound and Electric Dry Needling for Patients With Medial Epicondylalgia
- ClinicalTrials.gov ID
- NCT04609735
- Acronym / sponsor ID
- AAMT50
- Conditions
- Epicondylalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Electric DN, Manual therapy, exercise and US | Experimental | Other: Electric Dry Needling, Manual Therapy, Exercise and UltrasoundDry needling, manual therapy, exercise and ultrasound |
| Active comparator: Manual therapy, exercise and ultrasound | Active comparator | Other: Manual Therapy, Exercise and UltrasoundActive comparator: Manual therapy, exercise and ultrasound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric Dry Needling, Manual Therapy, Exercise and UltrasoundElectric Dry Needling, Manual Therapy, Exercise and Ultrasound | Other | Experimental: Electric DN, Manual therapy, exercise and US |
| Manual Therapy, Exercise and UltrasoundElectric Dry Needling, Manual Therapy, Exercise and Ultrasound vs. Manual Therapy, Exercise and Ultrasound | Other | Active comparator: Manual therapy, exercise and ultrasound |
Primary outcome
Change in elbow pain intensity (NPRS)
Time frame: Baseline, 1-week, 4-weeks, 3-months
Numeric Pain Rating Score. Higher scores mean greater pain
3 secondary outcomes
Disabilities of the Arm, Shoulder and Hand
Time frame: Baseline, 1-week, 4-weeks, 3-months
Change in Global rating of change score
Time frame: 4-weeks, 3-months
Change in Medication Intake (Frequency of Medication Intake in last week)
Time frame: Baseline, 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Dunning, DPT PhD principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Dry Needling, Manual Therapy, Exercise and Ultrasound and Manual Therapy, Exercise and Ultrasound in people with Epicondylalgia, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Dunning, DPT PhD (801-707-9056, jamesdunning@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in elbow pain intensity (NPRS) (time frame: Baseline, 1-week, 4-weeks, 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.