Radial Nerve Block for Treatment of Tennis Elbow

NCT ID: NCT03262623

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2022-04-30

Brief Summary

Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.

Objectives: The primary objective of this study is to assess the effectiveness of nerve stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.

Methods: This is a prospective randomized, double blind clinical trial. Patients will be randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will receive placebo through radial nerve block. Patients will be followed up for 2 weeks.

Detailed Description

Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. It is a major arm disorder which occurs commonly in adults between 30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral epicondylitis results from the overuse of the extensor muscles, causing inflammation or irritation of the tendon insertion. It is common in workers whose job requires manual and repetitive work .

Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.

To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block for the treatment of lateral epicondylitis.

Conditions

Pain, Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Radial nerve block

Patients will receive radial nerve block guided by a nerve stimulator.

Group Type: EXPERIMENTAL

Radial nerve block

Intervention Type: OTHER

A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml.

Placebo

Patients will receive placebo through radial nerve block

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline

Interventions

Radial nerve block

A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml.

Intervention Type: OTHER

Placebo

A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years and above
• presenting with refractory elbow pain

Exclusion Criteria

patients with:

• osteoarthritis,
• rheumatoid arthritis,
• olecranon bursitis,
• radial nerve entrapment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zoher Naja, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

Makassed General Hospital

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Zoher Naja, MD

Role: CONTACT

zouhnaja@yahoo.com

+9611636000 ext. 6405

Facility Contacts

Zoher Naja, MD

Role: primary

zouhnaja@yahoo.com

+9611636000 ext. 6941

Other Identifiers

1082017

Identifier Type: -

Identifier Source: org_study_id