Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia

NCT ID: NCT03167710

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2021-03-15

Brief Summary

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The purpose of this research is to compare two different approaches for treating patients with lateral epicondylalgia: electric dry needling, thrust manipulation and stretching versus impairment-based manual therapy, exercise and ultrasound. Physical therapists commonly use all of these techniques to treat lateral epicondyalgia. This study is attempting to find out if one treatment strategy is more effective than the other.

Detailed Description

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Patients with epicondyalgia will be randomized to receive 2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) electric dry needling, thrust manipulation and stretching or (2) impairment-based manual therapy, exercise and ultrasound

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dry needling, manipulation stretching

Group Type EXPERIMENTAL

Dry Needling, manipulation, stretching

Intervention Type OTHER

HVLA thrust manipulation to elbow, wrist and spine (C5-C6). Dry needling to wrist extensor muscles on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.

manual therapy, exercise, ultrasound

Group Type ACTIVE_COMPARATOR

manual therapy, exercise, ultrasound

Intervention Type OTHER

Impairment-based manual therapy, exercise and ultrasound targeting the wrist extensors on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.

Interventions

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manual therapy, exercise, ultrasound

Impairment-based manual therapy, exercise and ultrasound targeting the wrist extensors on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.

Intervention Type OTHER

Dry Needling, manipulation, stretching

HVLA thrust manipulation to elbow, wrist and spine (C5-C6). Dry needling to wrist extensor muscles on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adult between 18 and 60 years old that is able to speak English.
2. Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain, consistent with lateral epicondylitis:
3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months:
4. Diagnosis of lateral epicondylitis, defined as two of more of the following:

1. Pain on palpation over the lateral epicondyle and the associated common extensor unit
2. Pain on gripping a hand dynamometer
3. Pain with stretching or contraction of the wrist extensor muscles

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. Report of systemic neurological disorders and/or neurological deficits to include the following:

1. 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)
2. Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
3. 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)
4. History of whiplash injury within the previous 6 weeks
4. History of surgery to the head/neck or affected upper extremity.
5. Psychiatric disorders or cognitively impaired
6. Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Alabama Physical Therapy & Acupuncture

OTHER

Sponsor Role lead

Responsible Party

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James Dunning, DPT, MSc, FAAOMPT

Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Dunning, DPT

Role: PRINCIPAL_INVESTIGATOR

American Academy of Manipulative Therapy

Locations

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Evolution Sports Physiotherapy

Cockeysville, Maryland, United States

Site Status

Countries

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United States

References

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Young I, Dunning J, Mourad F, Escaloni J, Bliton P, Fernandez-de-Las-Penas C. Clinimetric analysis of the numeric pain rating scale, patient-rated tennis elbow evaluation, and tennis elbow function scale in patients with lateral elbow tendinopathy. Physiother Theory Pract. 2025 Aug;41(8):1712-1720. doi: 10.1080/09593985.2025.2450090. Epub 2025 Jan 10.

Reference Type DERIVED
PMID: 39793982 (View on PubMed)

Dunning J, Mourad F, Bliton P, Charlebois C, Gorby P, Zacharko N, Layson B, Maselli F, Young I, Fernandez-de-Las-Penas C. Percutaneous tendon dry needling and thrust manipulation as an adjunct to multimodal physical therapy in patients with lateral elbow tendinopathy: A multicenter randomized clinical trial. Clin Rehabil. 2024 Aug;38(8):1063-1079. doi: 10.1177/02692155241249968. Epub 2024 Apr 26.

Reference Type DERIVED
PMID: 38676324 (View on PubMed)

Other Identifiers

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AAMT0010

Identifier Type: -

Identifier Source: org_study_id

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