Hyaluronate Injection for Lateral Epicondylitis

April 23, 2020 updated by: Shaare Zedek Medical Center

Hyaluronate Injection for Lateral Epicondylitis: A Double-blind Randomized Controlled Trial

This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally been used to treat knee osteoarthritis. There are a small number of studies in the literature that suggest that HA injections can be very effective for tendinosis. Although LE has been studied with literally hundreds of articles published, very little treatment has proven to be efficacious. This study will investigate the effectiveness of hyaluronate in treatment of chronic LE. This will include a two arm study with one formulation of HA tested against saline injections as the control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized and blinded into one of the two arms. Patients will receive 3 injections total spaced over a 4 week period. After the injections are completed, patients will return for evaluation at 3, 6 and 12 months from the initial injection. A total of 72 patients will be divided into the 2 groups. The questionnaires will be administered by a research assistant blinded to the randomization. Three different outcomes measures will be collected, all patient-oriented including the Patient Rated Tennis Elbow Evaluation (PRTEE), Visual Analog Score (VAS) for pain while at rest and with maximum grip, and the short form Disabilities of the Arm, Shoulder and Hand (quickDASH).

The primary outcome measure will be the VAS for pain at 3 months from the initial injection. All measures will be evaluated at baseline then again at 12 months from the initial injection.

HA formulation will be Intragel (IBSA) which include 2cc with a concentration of 16mg per 2cc. The molecular weight with Intragel averaging 800-1200 kiloDaltons.

The syringes will be coded and the injections blinded. The injections will be given 1cm distal to the lateral epicondyle at the site of maximum tenderness. The needle will be introduced to the depth of the bone then withdrawn 1-2mm. The injection will be given in two locations in and around the point of maximum tenderness.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

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

  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Experimental: Intragel
Intragel (IBSA) has an average size of 800-1200 kDaltons. Intragel will give given with a concentration of 16mg/2cc. Each injection (2cc) injection will be given at baseline, then 2 weeks and 4 weeks from the baseline.
Drug: Intragel
Intragel has an average molecular weight of 800-1200 kDaltons.
Other Names:
  • hyaluronate
  • Sinovial
Active Comparator: Saline
Saline injections will be given similar to the active hyaluronic injections. Each injection (2cc) will be given at baseline, then 2 weeks and 4 weeks from the baseline.
Drug: Saline
Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score (VAS) for pain with maximum grip.
Time Frame: 3 months from baseline.
For the (visual analogue score) VAS pain score, patients will be asked to rate their pain after performing a maximum grip using a Jamar hydraulic dynamometer. They will score their pain using the VAS.
3 months from baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Rated Tennis Elbow Evaluation (PRTEE): Change from Baseline to value at 12
Time Frame: Baseline then 3,6 and 12 months from baseline.
This is a 15 question validated survey, specific to tennis elbow. It is composed of a pain and function measure. The best score of 0 represents no pain and maximum function.
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.
For this VAS pain score, patients will be asked to rate their pain using the following standard question: "How much pain do you feel when doing an activity that involves gripping such as shaking hands, opening a jar or carrying something?". They will then score their level of pain using the VAS.
Baseline then 3, 6, and 12 months from baseline.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: Baseline then 3, 6, and 12 months from baseline.
The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Baseline then 3, 6, and 12 months from baseline.

Collaborators and Investigators

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

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Gershon Zinger, MD MS, Shaare Zedek Medical Center, Jerusalem Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 18, 2017

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

September 14, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014813CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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