Corticosteroid and Lidocain Injections for Tennis Elbow

Lateral Epicondylitis Clinical Trial

Official title:

Corticosteroid and Lidocain Injections for Tennis Elbow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700906
• Other study ID #: 20130713R
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: March 1, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Drug:
• Corticosteroid
triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.
• Lidocaine
For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline, 2 weeks, 2 months	No
Secondary	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.	baseline, 2 weeks, 2 months	No
Secondary	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.	baseline, 2 weeks, 2 months	No
Secondary	treatment satisfaction	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	No