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

NCT03167710 | Completed

• 1 other identifier: AAMT0010
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (2)

• Change in Elbow pain (NPRS) (Rating Score)

  Rating Score. Baseline score must exceed 2/10 to be included in the study.

  Baseline, 1 week, 4 weeks, 3 months

• Change in Patient-related Tennis Elbow Questionnaire

  The pain, disability-specific activities and disability common activities section of the PRTEE are collectively measured on a 0-150 point scale. Greater scores indicate increased disability. Baseline must exceed 10/50 on the pain section, 10/60 on the specific activities section and 10/40 on the common activities to be included in the study.

  Baseline, 1 week, 4 weeks, 3 months

Secondary Outcomes (3)

• Change in Global Rating of Change Score

  1 week, 4 weeks, 3 months

• Change in Tennis Elbow Functional Scale

  Baseline, 1 week, 4 weeks, 3 months

• Change in Medication Intake (Frequency of medication intake in last week)

  Baseline, 3 months

Study Arms (2)

dry needling, manipulation stretching

EXPERIMENTAL

Other: Dry Needling, manipulation, stretching

manual therapy, exercise, ultrasound

ACTIVE COMPARATOR

Other: manual therapy, exercise, ultrasound

Interventions

Dry Needling, manipulation, stretching 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.

dry needling, manipulation stretching

manual therapy, exercise, ultrasound 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.

manual therapy, exercise, ultrasound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult between 18 and 60 years old that is able to speak English.
• Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain, consistent with lateral epicondylitis:
• Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months:
• Diagnosis of lateral epicondylitis, defined as two of more of the following:
• Pain on palpation over the lateral epicondyle and the associated common extensor unit
• Pain on gripping a hand dynamometer
• Pain with stretching or contraction of the wrist extensor muscles

You may not qualify if:

• 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
• Report of systemic neurological disorders and/or neurological deficits to include the following:
• 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)
• Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
• 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)
• History of whiplash injury within the previous 6 weeks
• History of surgery to the head/neck or affected upper extremity.
• Psychiatric disorders or cognitively impaired
• Pregnancy

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Evolution Sports Physiotherapy

Cockeysville, Maryland, 21030, United States

Location

Related Publications (2)

• 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.

  PMID: 39793982 DERIVED

• 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.

  PMID: 38676324 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Dry Needling; Musculoskeletal Manipulations; Exercise; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• James Dunning, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: June 15, 2017
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

US (1)