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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167710
• Other study ID #: AAMT0010
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: September 2023
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Evolution Sports Physiotherapy	Cockeysville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

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