Corticosteroid and Lidocain Injections for Tennis Elbow

NCT02700906 | Completed

• 1 other identifier: 20130713R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tennis Elbow; Lateral Epicondylitis

Keywords

Lateral epicondylitis; tennis elbow; Lidocaine; corticosteroid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• pain-free grip strength

  baseline, 2 weeks, 2 months

• ultrasound elbow assessment

  baseline, 2 weeks, 2 months

• treatment satisfaction

  baseline, 2 weeks, 2 months

Study Arms (2)

Corticosteroid injection

ACTIVE COMPARATOR

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

Drug: Corticosteroid

Lidocaine injection

ACTIVE COMPARATOR

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

Drug: Lidocaine

Interventions

Corticosteroid DRUG

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

Corticosteroid injection

Lidocaine DRUG

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

Lidocaine injection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei, 111, Taiwan

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Adrenal Cortex Hormones; Lidocaine

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Lin-Fen Lin-Fen, M.D

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: March 7, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)