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
About this trial
This is an interventional treatment trial for Pain, Elbow
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
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
NCT ID
NCT03262623
First Posted
August 23, 2017
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
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
Learn more about this trial
Radial Nerve Block for Treatment of Tennis Elbow
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