NCT02258295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

September 14, 2014

Last Update Submit

April 23, 2020

Conditions

Tennis Elbow

Keywords

Lateral Humeral EpicondylitisTendinitisTendinosisAthletic InjuriesElbow JointSports Medicine

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Score (VAS) for pain with maximum grip.

    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.

    3 months from baseline.

Secondary Outcomes (2)

  • Patient Rated Tennis Elbow Evaluation (PRTEE): Change from Baseline to value at 12

    Baseline then 3,6 and 12 months from baseline.

  • Visual Analogue Score (VAS) for pain at rest.

    Baseline then 3, 6, and 12 months from baseline.

Other Outcomes (1)

  • Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)

    Baseline then 3, 6, and 12 months from baseline.

Study Arms (2)

Intragel

EXPERIMENTAL

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

Saline

ACTIVE COMPARATOR

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

Interventions

IntragelDRUG

Intragel has an average molecular weight of 800-1200 kDaltons.

Also known as: Sinovial, hyaluronate
Intragel
SalineDRUG

Saline

Saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20205851BACKGROUND

MeSH Terms

Conditions

Tennis ElbowTendinopathyAthletic Injuries

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Gershon Zinger, MD MS

    Shaare Zedek Medical Center, Jerusalem Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2014

First Posted

October 7, 2014

Study Start

January 18, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

IL(1)