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Corticosteroid and Lidocain Injections for Tennis Elbow

Primary Purpose

Tennis Elbow, Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Corticosteroid
Lidocaine
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral epicondylitis, tennis elbow, Lidocaine, corticosteroid

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 20 and 75 years of age, with lateral elbow pain ≥4 in pain VAS for at least 1 month
  • Reproducibility of pain by 2 or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow; resisted wrist extension (dorsiflexion) and pronation with the elbow in extension
  • Pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension.

Exclusion Criteria:

  • not fulfill inclusion criteria

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Corticosteroid injection

Lidocaine injection

Arm Description

For corticosteroid injection, triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.

For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.

Outcomes

Primary Outcome Measures

change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE)
The primary outcome measure is the change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE), which is a tennis elbow-specific questionnaire evaluating disease-specific quality of life. PRTEE includes a 5-item pain scale, with o indicating no pain and 10 indicating the worst pain imaginable; a 10-item functional disability scale, with 0 indicating no difficulty and 10 indicating greatest difficulty (unable to do). The scores range from 0 (good quality-of- life, no pain or disability) to 100 (poor-quality of-life, extremes pain and disability).

Secondary Outcome Measures

pain-free grip strength
The grip strength is a commonly used objective measure of tennis elbow-related disability, with good test-retest (Pearson correlation, r≥0.80) and validity (±3%) measures. The participants will sit in a chair with their shoulder flexed at 90 degrees, their elbows extended, and their forearms in neutral position. All participants are instructed to squeeze the dynamometer and cease squeezing before the onset of pain. The mean of the three replications will be recorded, with each measure separated by 60-sec interval.
ultrasound elbow assessment
Another secondary outcome measure is ultrasound assessments of common extensor tendons at elbow, using published ordinary scales for hypoechogenecity, tendon thickness, and neovascularity, which have been reported to be associated tendinopathy.
treatment satisfaction
Treatment satisfaction included patient's rating of the treatment outcome, using a 5-point(0, very dissatisfied; 5 very satisfied) scale.

Full Information

First Posted
February 2, 2016
Last Updated
March 1, 2016
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02700906
Brief Title
Corticosteroid and Lidocain Injections for Tennis Elbow
Official Title
Corticosteroid and Lidocain Injections for Tennis Elbow
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.
Detailed Description
Lateral epicondylitis or tennis elbow is a tendinopathy of the common extensor origin of the lateral elbow, and is estimated to have an annual incidence of 1-3%. It is characterized by tenderness over the lateral epicondyle of the humerus, normal range of motion, and pain on resisted extension of the wrist or fingers. Symptoms can persist for between 6 months and 2 years but usually resolve within 12 months. Although tennis elbow is often self-limited, around 20% of cases are refractory to conservative care. Tennis elbow is now thought to be non-inflammatory, and the pathologies are characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration, and neovascularization. Treatment of tennis elbow includes relative rest, physical therapy (therapeutic exercise, massage, therapeutic ultrasound, lower power laser, etc.), analgesics, non-steroidal anti-inflammatory drugs, glyceryl trinitrate patches, injection therapy (corticosteroid, hyaluronan gel, botulinum toxin, and autologous platelet-rich plasma), shock wave therapy, and even surgery. Previous studies showed corticosteroid injection is effective in the short term, but is harmful in the long-term, and is more likely to have a recurrence. In consideration of a degenerative lesion in tennis elbow, corticosteroid injection may be not an ideal agent. Although plate-rich plasma injection showed promising results, the high cost limited its widespread clinical use. Since local lidocain injection is commonly used in the management of myofascial pain syndrome, it might be effective in the treatment of tendinopathy like tennis elbow. The purpose of this study is to compare the effect of corticosteroid injection and lidocain injection in the treatment of tennis elbow. The investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Lateral Epicondylitis
Keywords
Lateral epicondylitis, tennis elbow, Lidocaine, corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
For corticosteroid injection, triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.
Arm Title
Lidocaine injection
Arm Type
Active Comparator
Arm Description
For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.
Primary Outcome Measure Information:
Title
change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE)
Description
The primary outcome measure is the change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE), which is a tennis elbow-specific questionnaire evaluating disease-specific quality of life. PRTEE includes a 5-item pain scale, with o indicating no pain and 10 indicating the worst pain imaginable; a 10-item functional disability scale, with 0 indicating no difficulty and 10 indicating greatest difficulty (unable to do). The scores range from 0 (good quality-of- life, no pain or disability) to 100 (poor-quality of-life, extremes pain and disability).
Time Frame
baseline, 2 weeks, 2 months
Secondary Outcome Measure Information:
Title
pain-free grip strength
Description
The grip strength is a commonly used objective measure of tennis elbow-related disability, with good test-retest (Pearson correlation, r≥0.80) and validity (±3%) measures. The participants will sit in a chair with their shoulder flexed at 90 degrees, their elbows extended, and their forearms in neutral position. All participants are instructed to squeeze the dynamometer and cease squeezing before the onset of pain. The mean of the three replications will be recorded, with each measure separated by 60-sec interval.
Time Frame
baseline, 2 weeks, 2 months
Title
ultrasound elbow assessment
Description
Another secondary outcome measure is ultrasound assessments of common extensor tendons at elbow, using published ordinary scales for hypoechogenecity, tendon thickness, and neovascularity, which have been reported to be associated tendinopathy.
Time Frame
baseline, 2 weeks, 2 months
Title
treatment satisfaction
Description
Treatment satisfaction included patient's rating of the treatment outcome, using a 5-point(0, very dissatisfied; 5 very satisfied) scale.
Time Frame
baseline, 2 weeks, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 20 and 75 years of age, with lateral elbow pain ≥4 in pain VAS for at least 1 month Reproducibility of pain by 2 or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow; resisted wrist extension (dorsiflexion) and pronation with the elbow in extension Pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension. Exclusion Criteria: not fulfill inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Lin-Fen, M.D
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Corticosteroid and Lidocain Injections for Tennis Elbow

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