What side effects are associated with this type of intervention?

Common treatments for Tennis Elbow include manual therapy, exercise, ultrasound, and electric dry needling. Side effects of electric dry needling and similar electrical stimulation therapies can include local pain at the injection or stimulation site, stiffness, cramping, hematoma, and paresthesias. Additionally, there may be a risk of temporary hand weakness, particularly with botulinum toxin injections. These side effects are generally mild and transient but should be discussed with a healthcare provider to ensure the best treatment approach.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of Tennis Elbow (medial epicondylalgia). However, it does discuss a study comparing manual therapy, exercise, and ultrasound with and without electric dry needling. Common treatments for Tennis Elbow typically include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and in some cases, surgical intervention. Electric dry needling, which involves stimulating trigger points to reduce pain and improve function, is a technique used by physical therapists but is not specifically highlighted as FDA-approved in the context provided.

What other types of research exist?

Promising novel alternatives to Electric Dry Needling for Tennis Elbow patients include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown significant pain reduction in migraine patients and may be applicable for localized pain conditions. 2) Remote Electrical Neuromodulation, which uses nonpainful electrical skin stimulation and has demonstrated efficacy in reducing acute pain. 3) Acupuncture, which has been supported by multiple trials for chronic pain management and may offer benefits for Tennis Elbow. These alternatives provide noninvasive options that can be considered in consultation with a healthcare provider.

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Dry Needling vs. Standard Therapy for Tennis Elbow

N/A

Recruiting

Led By James Dunning, DPT PhD

Research Sponsored by Alabama Physical Therapy & Acupuncture

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 tenderness 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) and pain exacerbated by resisted wrist flexion and forearm pronation at an angle of 90°

Must not have

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 previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week, 4-weeks, 3-months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods for treating inner elbow pain: one using hands-on therapy, exercises, and ultrasound, and another adding electric dry needling. It aims to find out which method is more effective for patients with this condition. Dry needling is similar to acupuncture and frequently regarded as a form of acupuncture, with evidence supporting its use for localized musculoskeletal pain conditions.

Who is the study for?

This trial is for adults aged 18-60 with medial epicondylalgia (tennis elbow) pain for at least 6 weeks, who haven't had related treatments in the past 6 months. Participants must speak English and have a specific diagnosis of medial epicondylalgia. Pregnant individuals or those with certain medical conditions like severe hypertension, diabetes, heart disease, previous elbow surgery or injuries are excluded.

What is being tested?

The study compares two treatment strategies for tennis elbow: one group receives manual therapy, exercise and ultrasound; another group gets these plus electric dry needling. The goal is to determine if adding electric dry needling improves outcomes.

What are the potential side effects?

Potential side effects may include discomfort at the needle insertion site from dry needling, soreness from manual therapy and exercise, and skin irritation from ultrasound. Individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had treatments like physical therapy for elbow pain in the last 6 months.

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I have been diagnosed with pain on the inside of my elbow, worsened by certain wrist and forearm movements.

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I am between 18 and 60 years old and can speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had issues with my joints, ligaments, or nerves in my elbow.

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I have had elbow surgery, dislocation, fracture, or tendon rupture in the past.

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I have nerve or spinal issues, including recent severe neck or back injuries.

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I have had surgery on my head, neck, upper spine, or arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week, 4-weeks, 3-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-week, 4-weeks, 3-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week, 4-weeks, 3-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in elbow pain intensity (NPRS)

Secondary study objectives

Change in Global rating of change score

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

Disabilities of the Arm, Shoulder and Hand

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: Electric DN, Manual therapy, exercise and USExperimental Treatment1 Intervention

Dry needling, manual therapy, exercise and ultrasound

Group II: Active comparator: Manual therapy, exercise and ultrasoundActive Control1 Intervention

Active comparator: Manual therapy, exercise and ultrasound

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tennis Elbow, such as dry needling, glucocorticoid injections, and physical therapy, work through different mechanisms to alleviate pain and improve function. Dry needling targets myofascial trigger points, evoking anti-nociceptive effects by modulating segmental mechanisms, which can reduce pain and muscle tension. Glucocorticoid injections provide short-term pain relief by reducing inflammation, although they may have high recurrence rates and potential long-term drawbacks. Physical therapy, including eccentric exercises, helps strengthen the affected tendons and improve their resilience. Understanding these mechanisms is crucial for Tennis Elbow patients as it helps them make informed decisions about their treatment options, balancing immediate pain relief with long-term recovery and function improvement.

Effectiveness of manual therapy in patients with tension-type headache. A systematic review and meta-analysis.Manual treatment for cervicogenic headache and active trigger point in the sternocleidomastoid muscle: a pilot randomized clinical trial.Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects.