Corticosteroid and Lidocain Injections for Tennis Elbow

NCT ID: NCT02700906

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Tennis Elbow; Lateral Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Corticosteroid injection

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

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

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

Lidocaine injection

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

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

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

Interventions

Corticosteroid

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

Intervention Type: DRUG

Lidocaine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin-Fen Hsieh

Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin-Fen Lin-Fen, M.D

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei, Taiwan

Countries

Taiwan

Other Identifiers

20130713R

Identifier Type: -

Identifier Source: org_study_id