Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
Primary Purpose
Epicondylitis, Tennis Elbow, Epicondylosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OVT (Sodium Hyaluronate)
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Epicondylitis focused on measuring sodium hyaluronate, OVT, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OVT (Sodium Hyaluronate)
Saline
Arm Description
Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe.
0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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.
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
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.
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
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.
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
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.
The change from baseline in Grip Strength using a hydraulic hand dynamometer at 4, 12, 18, and 26 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.
The change from baseline in rescue medication consumption (acetaminophen/ paracetamol) through weeks 4-26 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.
The incidence, timing, severity, and relationship to treatment of all adverse events will be classified using MedDRA.
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.
Full Information
NCT ID
NCT02861183
First Posted
August 5, 2016
Last Updated
November 28, 2022
Sponsor
Anika Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02861183
Brief Title
Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
Official Title
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Project was placed on hold indefinitely as the project resources were unavailable for this to move forward.
Study Start Date
September 2025 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anika Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).
Detailed Description
The objective of this study is to assess the safety and effectiveness of two weekly peri-osteotendinous injections of OVT for relief of pain in patients with lateral epicondylosis in a multi-center, randomized, double-blind, placebo controlled superiority study. A total of 186 subjects will be enrolled at up to 20 centers in the US and Europe. The randomization ratio will be 2:1 (2 OVT subjects: 1 placebo subject). The entire study duration from first subject in to last subject out is approximately one year. The enrollment phase is approximately 6 months with a follow-up phase of 6 months. Visits are scheduled at baseline, 1 week, 4 weeks, 12 weeks, 18 weeks, and 26 weeks. Study injections will be given at the baseline and 1 week visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Tennis Elbow, Epicondylosis
Keywords
sodium hyaluronate, OVT, hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OVT (Sodium Hyaluronate)
Arm Type
Experimental
Arm Description
Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe.
Intervention Type
Device
Intervention Name(s)
OVT (Sodium Hyaluronate)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 weeks post injection
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
4, 18, 26 weeks post-injection
Title
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
Description
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.
Time Frame
26 weeks post-injection
Title
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
Description
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.
Time Frame
26 weeks post-injection
Title
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
Description
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.
Time Frame
26 weeks post-injection
Title
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
Description
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.
Time Frame
26 weeks post-injection
Title
The change from baseline in Grip Strength using a hydraulic hand dynamometer at 4, 12, 18, and 26 weeks comparing the OVT group to the saline control group
Description
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.
Time Frame
4,12,18 and 26 weeks post-injection
Title
The change from baseline in rescue medication consumption (acetaminophen/ paracetamol) through weeks 4-26 comparing the OVT group to the saline control group
Description
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.
Time Frame
26 weeks post-injection
Title
The incidence, timing, severity, and relationship to treatment of all adverse events will be classified using MedDRA.
Description
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.
Time Frame
During injection, 4, 12, 18 and 26 weeks post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TBD TBD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
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