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Radial Nerve Block for Treatment of Tennis Elbow

Primary Purpose

Pain, Elbow

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Radial nerve block
Placebo
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and above
  • presenting with refractory elbow pain

Exclusion Criteria:

patients with:

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

Sites / Locations

  • Makassed General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Radial nerve block

Placebo

Arm Description

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

Patients will receive placebo through radial nerve block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2017
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03262623
Brief Title
Radial Nerve Block for Treatment of Tennis Elbow
Official Title
Localized Radial Nerve Block for Treatment of Tennis Elbow: a Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radial nerve block
Arm Type
Experimental
Arm Description
Patients will receive radial nerve block guided by a nerve stimulator.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo through radial nerve block
Intervention Type
Other
Intervention Name(s)
Radial nerve block
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline
Primary Outcome Measure Information:
Title
Pain score
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6405
Email
zouhnaja@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6941
Email
zouhnaja@yahoo.com

12. IPD Sharing Statement

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Radial Nerve Block for Treatment of Tennis Elbow

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