Radial Nerve Block for Treatment of Tennis Elbow

NCT03262623 | Unknown

• 1 other identifier: 1082017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Elbow

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain will be measured through the Visual Analogue Scale (VAS). The scale ranges between 0 and 10, with 0 being no pain and 10 maximum possible pain

  2 weeks

Study Arms (2)

Radial nerve block

EXPERIMENTAL

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

Other: Radial nerve block

Placebo

PLACEBO COMPARATOR

Patients will receive placebo through radial nerve block

Other: Placebo

Interventions

Radial nerve block 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.

Radial nerve block

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above
• presenting with refractory elbow pain

You may not qualify if:

• patients with:
• osteoarthritis,
• rheumatoid arthritis,
• olecranon bursitis,
• radial nerve entrapment

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zoher Naja, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoher Naja, MD

CONTACT

+9611636000; zouhnaja@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: October 1, 2017
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

LE (1)