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

Not Applicable

Completed

• Conditions: Lateral Epicondylitis
• Interventions: Other: manual therapy, exercise, ultrasound; Other: Dry Needling, manipulation, stretching

• Registration Number: NCT03167710
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Study Start: 2017-06-15
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual therapy, exercise, ultrasound	manual therapy, exercise, ultrasound	-
dry needling, manipulation stretching	Dry Needling, manipulation, stretching	-

Primary Outcome Measures

Name	Time	Method
Change in Elbow pain (NPRS) (Rating Score)	Baseline, 1 week, 4 weeks, 3 months	Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Patient-related Tennis Elbow Questionnaire	Baseline, 1 week, 4 weeks, 3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Evolution Sports Physiotherapy; 🇺🇸 Cockeysville, Maryland, United States