Clinical trial NCT02258295: Hyaluronate Injection for Lateral Epicondylitis
Official title: Hyaluronate Injection for Lateral Epicondylitis: A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tennis Elbow
Keywords: Lateral Humeral Epicondylitis
Tendinitis
Tendinosis
Athletic Injuries
Elbow Joint
Sports Medicine
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Visual Analogue Score (VAS) for pain with maximum grip.
timeFrame: 3 months from baseline.
Secondary outcomes:
measure: Patient Rated Tennis Elbow Evaluation (PRTEE): Change from Baseline to value at 12
timeFrame: Baseline then 3,6 and 12 months from baseline.
measure: Visual Analogue Score (VAS) for pain at rest.
timeFrame: Baseline then 3, 6, and 12 months from baseline.
Other outcomes:
measure: Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: Baseline then 3, 6, and 12 months from baseline.
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem Israel
name: Gershon Zinger, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrella RJ, Cogliano A, Decaria J, Mohamed N, Lee R. Management of Tennis Elbow with sodium hyaluronate periarticular injections. Sports Med Arthrosc Rehabil Ther Technol. 2010 Feb 2;2:4. doi: 10.1186/1758-2555-2-4.