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Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study

Primary Purpose

Tennis Elbow, Lateral Epicondylitis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo Injection
Physical Therapy
Corticosteroid Injections
Prolotherapy
Sponsored by
Christine M. Kleinert Institute for Hand and Microsurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring tennis elbow, lateral epicondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment
  • conservative treatment of tennis elbow is recommended as standard of care treatment
  • over the age of 18 and under the age of 65
  • ability to give informed consent

Exclusion Criteria:

  • treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow
  • congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months
  • immobility casts or splints within the last 6 months for tennis elbow
  • co-existing elbow diagnosis (i.e. osteoarthritis or instability)
  • pregnant women, women trying to get pregnant, or breastfeeding women
  • under the age of 18 or over the age of 65

Sites / Locations

  • Christine M. Kleinert Institute of Hand and MicrosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Corticosteroid Injections

Prolotherapy

Placebo

Physical Therapy

Arm Description

Patients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection.

Participants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine.

Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).

Participants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening.

Outcomes

Primary Outcome Measures

Symptom Severity in pre intervention assessments
Symptom severity in post-intervention assessments

Secondary Outcome Measures

Functional status score pre-intervention
The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention.
Functional status score severity- post intervention
The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention

Full Information

First Posted
June 11, 2012
Last Updated
January 23, 2018
Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
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1. Study Identification

Unique Protocol Identification Number
NCT01897259
Brief Title
Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
Official Title
Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Lateral Epicondylitis
Keywords
tennis elbow, lateral epicondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid Injections
Arm Type
Active Comparator
Arm Description
Patients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection.
Arm Title
Prolotherapy
Arm Type
Active Comparator
Arm Description
Participants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
Participants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening.
Intervention Type
Drug
Intervention Name(s)
Placebo Injection
Intervention Description
Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy
Intervention Description
Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid Injections
Intervention Description
Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.
Intervention Type
Drug
Intervention Name(s)
Prolotherapy
Intervention Description
Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.
Primary Outcome Measure Information:
Title
Symptom Severity in pre intervention assessments
Time Frame
12 months
Title
Symptom severity in post-intervention assessments
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Functional status score pre-intervention
Description
The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention.
Time Frame
12 months
Title
Functional status score severity- post intervention
Description
The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention
Time Frame
12 months

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: pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment conservative treatment of tennis elbow is recommended as standard of care treatment over the age of 18 and under the age of 65 ability to give informed consent Exclusion Criteria: treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months immobility casts or splints within the last 6 months for tennis elbow co-existing elbow diagnosis (i.e. osteoarthritis or instability) pregnant women, women trying to get pregnant, or breastfeeding women under the age of 18 or over the age of 65
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuna Ozyurekoglu, MD
Phone
502-561-4286
Email
tozyurekoglu@kleinertkutz.com
First Name & Middle Initial & Last Name or Official Title & Degree
Millicent L Horn, BS
Phone
502-562-0307
Email
mhorn@cmki.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
Organizational Affiliation
Christine M. Kleinert Institute for Hand and Microsurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christine M. Kleinert Institute of Hand and Microsurgery
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina L Kaufman, PhD
Phone
502-562-0390
Email
ckaufman@cmki.org
First Name & Middle Initial & Last Name & Degree
Millicent L Horn, BS
Phone
502-562-0307
Email
mhorn@cmki.org
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD

12. IPD Sharing Statement

Learn more about this trial

Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study

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