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

Electric Dry Needling, Thrust Manipulation and Stretching Versus Impairment-based Manual Therapy, Exercise and Ultrasound for Patients With Lateral Epicondylalgia: A Multi-center Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03167710
Enrollment
143
Registered
2017-05-30
Start date
2017-06-15
Completion date
2021-03-15
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis

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.

Detailed description

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

Interventions

OTHERDry 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.

OTHERmanual 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.

Sponsors

Universidad Rey Juan Carlos
CollaboratorOTHER
Alabama Physical Therapy & Acupuncture
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Elbow pain (NPRS) (Rating Score)Baseline, 1 week, 4 weeks, 3 monthsRating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Patient-related Tennis Elbow QuestionnaireBaseline, 1 week, 4 weeks, 3 monthsThe 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.

Secondary

MeasureTime frameDescription
Change in Global Rating of Change Score1 week, 4 weeks, 3 months
Change in Tennis Elbow Functional ScaleBaseline, 1 week, 4 weeks, 3 monthsThe Tennis Elbow Functional Scale (TEFS) is a 0-40 that assesses disability related to lateral epicondylitis. Greater scores indicate increased disability.
Change in Medication Intake (Frequency of medication intake in last week)Baseline, 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026