Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)

NCT02861183 | Withdrawn DMC FDA Device

• 1 other identifier: OVT 16-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).

Conditions

Epicondylitis; Tennis Elbow; Epicondylosis

Keywords

sodium hyaluronate; OVT; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Change from baseline in elbow pain after grip as measured by a 100 mm Visual Analog Scale (VAS) at 12 weeks comparing the OVT group to the saline control group

  Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.

  12 weeks post injection

Secondary Outcomes (8)

• The change from baseline in elbow pain after grip as measured by a 100 mm VAS at 4, 18, and 26 weeks comparing the OVT group to the saline control group

  4, 18, 26 weeks post-injection

• The change from baseline in elbow pain after grip as measured by a 100 mm VAS through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group

  26 weeks post-injection

• The change from baseline in elbow pain at rest as measured by a 100 mm VAS through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group

  26 weeks post-injection

• The change from baseline in elbow pain as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) Pain and Function Questionnaire through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group

  26 weeks post-injection

• The change from baseline in elbow pain as measured by the Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group

  26 weeks post-injection

Study Arms (2)

OVT (Sodium Hyaluronate)

EXPERIMENTAL

Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe.

Device: OVT (Sodium Hyaluronate)

Saline

PLACEBO COMPARATOR

0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe.

Device: Saline

Interventions

OVT (Sodium Hyaluronate) DEVICE

A Peri-osteotendinous injection of OVT will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.

OVT (Sodium Hyaluronate)

Saline DEVICE

A Peri-osteotendinous injection of sterile saline will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 65 years of age
• Clinical diagnosis of unilateral lateral epicondylosis defined as:
• Pain reproducible on palpation of the lateral epicondyle / common extensor origin; and
• Pain reproducible during resisted wrist extension
• Subject is symptomatic for at least 6 weeks
• Subject has pain in the index lateral epicondyle after grip strength testing that measures ≥ 40 mm on a 100 mm VAS
• Subject must be willing to abstain from other pharmacological and surgical treatments of the index elbow for the duration of the study
• Subject is willing to discontinue all systemic and/or topical analgesics including NSAIDs, (except the rescue medication oral acetaminophen/paracetamol), for the treatment of lateral epicondylosis at least seven days before the initial treatment injection and through the completion of the study
• If pain medication is needed during the study, subject is willing to use only acetaminophen/paracetamol (up to a maximum of 3.0 grams per day per the package insert) for the treatment of elbow pain for the duration of the study
• At least twenty four hours prior to the Baseline Visit and each follow-up visit, the subject must discontinue use of acetaminophen/paracetamol, if used
• Subject is able to understand and comply with the requirements of the study and voluntarily provides consent

You may not qualify if:

• Subjects with a history of hypersensitivity to any of the ingredients in the hyaluronan or an inability to tolerate acetaminophen/paracetamol
• Subjects in which the investigator believes the anatomical landmarks for injection are unable to be adequately identified
• Subjects who have a history of surgery to the intra-articular joint of the index elbow and/or history of index elbow dislocation
• Any diagnosed pathology or trauma that causes pain or symptoms in the index elbow other than lateral epicondylosis (e.g. intra-articular pathology, ligament injury, cervical radiculopathy, radial tunnel syndrome, osteochondral radiocapitellar lesion or posterolateral elbow plica, pain starting after a motor vehicle accident)
• Hyaluronic acid injections in the index elbow within the last 6 months
• Steroid injections in the index elbow within the last 3 months
• Infections or skin diseases in the area of the injection site or elbow joint
• Known inflammatory or autoimmune disorders, or other pre-existing medical conditions that, in the opinion of the investigator, could impact healing or affect the ability of the subject to complete the study and comply with the study requirements
• Subject is taking medications at the time of consent which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment and opioid analgesics. Low dose aspirin (81 mg) used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
• Subject is receiving or in litigation for worker's compensation
• Subject is a woman who is pregnant or breastfeeding at the screening visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study
• Subject was involved in any other research study involving an investigational product, or a new application of an approved product, within 60 days of signing the Informed Consent Form (ICF)

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• TBD TBD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share