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Hyaluronate Injection for Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT02258295
Recruitment Status : Recruiting
First Posted : October 7, 2014
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Drug: Intragel Drug: Saline Phase 3

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 The needle will be introduced to the depth of the bone then withdrawn 1-2mm.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  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyaluronate Injection for Lateral Epicondylitis: A Double-blind Randomized Controlled Trial
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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:
  • Sinovial
  • hyaluronate

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258295


Contacts
Contact: Gershon Zinger, MD MS 011-972-2666174 GershonZinger@gmail.com
Contact: Bat-el Harris 011-972-5645503 batelharris@SZMC.org.il

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Bat-el Harris    011-972-2-5645503    batelharris@SZMC.org.il   
Sub-Investigator: Alex Bregman, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Gershon Zinger, MD MS Shaare Zedek Medical Center, Jerusalem Israel

Publications:
Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02258295     History of Changes
Other Study ID Numbers: 2014813CTIL
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shaare Zedek Medical Center:
Lateral Humeral Epicondylitis
Tendinitis
Tendinosis
Athletic Injuries
Elbow Joint
Sports Medicine

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries