Corticosteroid and Lidocain Injections for Tennis Elbow

March 1, 2016 updated by: Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticosteroid injection
For corticosteroid injection, triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.
Drug: Corticosteroid
triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.
Active Comparator: Lidocaine injection
For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.
Drug: Lidocaine
For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the composite score on the Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: baseline, 2 weeks, 2 months
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).
baseline, 2 weeks, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain-free grip strength
Time Frame: baseline, 2 weeks, 2 months
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.
baseline, 2 weeks, 2 months
ultrasound elbow assessment
Time Frame: baseline, 2 weeks, 2 months
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.
baseline, 2 weeks, 2 months
treatment satisfaction
Time Frame: baseline, 2 weeks, 2 months
Treatment satisfaction included patient's rating of the treatment outcome, using a 5-point(0, very dissatisfied; 5 very satisfied) scale.
baseline, 2 weeks, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Principal Investigator: Lin-Fen Lin-Fen, M.D, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130713R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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