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
|Condition or disease||Intervention/treatment||Phase|
|Tennis Elbow||Drug: Intragel Drug: Saline||Phase 3|
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 The needle will be introduced to the depth of the bone then withdrawn 1-2mm.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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
Intragel has an average molecular weight of 800-1200 kDaltons.
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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Gershon Zinger, MD MS||011-972-2666174||GershonZinger@gmail.com|
|Contact: Bat-el Harris||011-972-5645503||batelharris@SZMC.org.il|
|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|
|Principal Investigator:||Gershon Zinger, MD MS||Shaare Zedek Medical Center, Jerusalem Israel|