ClinicalTrials.gg
RecruitingNCT04609735Updated May 18, 2025

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

An interventional study of Electric Dry Needling, Manual Therapy, Exercise and Ultrasound and Manual Therapy, Exercise and Ultrasound in Epicondylalgia, sponsored by Alabama Physical Therapy & Acupuncture. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Epicondylalgia
03

In context

Lead sponsor

Alabama Physical Therapy & Acupuncture is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 use, fracture, RA, osteoporosis, severe vascular disease, , 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.
  1. Psychiatric disorders or cognitively impaired 7. Pregnancy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Experimental: Electric DN, Manual therapy, exercise and US

    Dry needling, manual therapy, exercise and ultrasound

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

  • Active comparator
    Active comparator: Manual therapy, exercise and ultrasound

    Active comparator: Manual therapy, exercise and ultrasound

    Other: Manual Therapy, Exercise and Ultrasound

Interventions

  • OtherElectric Dry Needling, Manual Therapy, Exercise and Ultrasound

    Electric Dry Needling, Manual Therapy, Exercise and Ultrasound

  • OtherManual Therapy, Exercise and Ultrasound

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

06

What researchers measure

Primary outcomes

  1. Change in elbow pain intensity (NPRS)

    Numeric Pain Rating Score. Higher scores mean greater pain

    Time frame: Baseline, 1-week, 4-weeks, 3-months

Secondary outcomes

  1. Disabilities of the Arm, Shoulder and Hand

    The DASH is measured on a 0-100 scale. Greater scores indicate increased disability.

    Time frame: Baseline, 1-week, 4-weeks, 3-months

  2. 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

    Time frame: 4-weeks, 3-months

  3. Change in Medication Intake (Frequency of Medication Intake in last week)

    Frequency of medication intake in last week

    Time frame: Baseline, 3-months

07

Study locations

1 of 1 sites recruiting
  • Mallers and Swoverland Orthopedic PT
    Fort Wayne, Indiana 46804, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2020 (actual). Primary completion is estimated for May 2026, 66 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2020
First posted
Oct 30, 2020
StartActual
Oct 31, 2020
Primary completionEst.
May 1, 2026
CompletionEst.
May 1, 2026
Last update
May 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04609735
Lead sponsor
Alabama Physical Therapy & Acupuncture
Responsible party
James Dunning, DPT, MSc, FAAOMPT (Director, American Academy of Manipulative Therapy, Alabama Physical Therapy & Acupuncture) — Principal investigator
First posted
Oct 30, 2020
Start date
Oct 31, 2020
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
May 18, 2025

Study contacts

James Dunning, DPT PhD
Contact
jamesdunning@hotmail.com
801-707-9056
Raymond J Butts, DPT PhD
Contact
fellowship@spinalmanipulation.org
803-422-3954
James Dunning, DPT PhD
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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