Hyaluronate Injection for Lateral Epicondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02258295
• Date of registration: 14/09/2014
• Prospective Registration: Yes
• Primary sponsor: Shaare Zedek Medical Center
• Public title: Hyaluronate Injection for Lateral Epicondylitis
• Scientific title: Hyaluronate Injection for Lateral Epicondylitis: A Double-blind Randomized Controlled Trial
• Date of first enrolment: January 18, 2017
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02258295
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Israel

Contacts

• Name: Gershon Zinger, MD MS
• Affiliation: Shaare Zedek Medical Center, Jerusalem Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

- Included will be patients older than 18 years with lateral epicondylitis. The criteria
for diagnosis will include pain and tenderness at the lateral epicondyle worse with
resisted wrist or finger extension (with the elbow in the extended position).

Exclusion Criteria:

- Excluded will be patients with history of prior elbow surgery, history of fracture or
dislocation, known inflammatory or autoimmune disorders, or known hypersensitivity to
HA.

- Exclusion will also include a known allergy to birds, feathers or egg products. If the
patient has complaints of pain or tenderness on exam in the area of the radial neck,
then a component of radial tunnel syndrome will be assumed and these patients will be
excluded from study.

- Patients that are pregnant will be excluded.

- Patients with medial epicondylitis

- Prior elbow surgery

- Elbow steroid injection in the past 3 months

- Inflammatory condition, like rheumatoid arthritis or lupus



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tennis Elbow

Intervention(s)

Drug: Saline

Drug: Intragel

Primary Outcome(s)

Visual Analogue Score (VAS) for pain with maximum grip. [Time Frame: 3 months from baseline.]

Secondary Outcome(s)

Patient Rated Tennis Elbow Evaluation (PRTEE): Change from Baseline to value at 12 [Time Frame: Baseline then 3,6 and 12 months from baseline.]

Visual Analogue Score (VAS) for pain at rest. [Time Frame: Baseline then 3, 6, and 12 months from baseline.]

Secondary ID(s)

2014813CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors