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Efficacy of Injection Therapy for Lateral Epicondylosis

Primary Purpose

Tennis Elbow

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dextrose prolotherapy

PrT-DMS

Platelet Rich Plasma injection

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring prolotherapy, Platelet rich plasma, tennis elbow, lateral epicondylosis

Eligibility Criteria

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

Inclusion Criteria:

age 18-65 years
diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor muscle provocation tests
self-reported CLE-related pain for at least 6 months
self-reported failure of at least 2 of the 3 most common treatments for CLE (a course of NSAIDS, physical therapy or corticosteroid injections).

Exclusion Criteria:

current bilateral CLE
a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity
self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy
current use of opioids for pain
anticoagulation or immunosuppressive therapy in the prior month
intent to use NSAIDs or steroids
known allergy to dextrose, acetaminophen or lidocaine
MRI contraindications: non-compatible metal in the CLE-affected upper extremity or severe claustrophobia
unresolved litigation
self-reported pregnancy. Pregnant women are excluded from the study because pregnancy changes the characteristics of connective tissue including ligaments and tendons associated with CLE and, so, is an unacceptable confounder in this pilot level study. There is no report however, about dextrose, morrhuate sodium or PrT being harmful to pregnant women. Therefore we will not draw confirmatory labs to ensure that women of childbearing age are not pregnant. Rather we will accept self-report on pregnancy status at the time of consent. If a woman becomes pregnant during the study she will be dropped from the study.

Sites / Locations

Northeast Family Medical Center
University of Wisconsin General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

No Intervention

Active Comparator

Arm Label

PrT-DMS

PrT-D

Waitlist

Platelet rich plasma

Arm Description

1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.

PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine

Outcomes

Primary Outcome Measures

Patient rated tennis elbow evaluation (PRTEE)

Validated disease specific quality of life questionnaire conducted at 0, 16 (all subjects) and 32 weeks (PrT only).The PRTEE will assess elbow related quality of life at each of the specified time points. Change in quality of life score in the study groups over time will be compared.

Secondary Outcome Measures

Biomedical (grip strength), ultrasound (US) and magnetic resonance imaging (MRI)

Pain-free- and maximum-grip strengths will be using a hand dynamometer, a simple squeeze device with which the force of the subject's grip strength is recorded.US and MRI will be obtained at baseline and 16 weeks.

Full Information

NCT ID

NCT01476605

First Posted

October 25, 2011

Last Updated

February 14, 2019

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT01476605

Brief Title

Efficacy of Injection Therapy for Lateral Epicondylosis

Official Title

The Efficacy of Prolotherapy and Platelet Rich Plasma Injections for Lateral Epicondylosis: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

November 1, 2011 (Actual)

Study Completion Date

December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

While evidence does not identify any conventional therapy as definitive for chronic lateral epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE. The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections commonly used in the treatment of moderate-to-severe tennis elbow using clinical, biomechanical and radiological outcomes. Data from this study will support a future confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In support of this goal, the investigators propose the following research questions. Does PrT or PRP, compared to waitlist control: improve pain- and function-dependent, CLE-specific quality of life among adults with CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis Elbow Evaluation? improve upper extremity performance among adults with CLE as assessed by a blinded assessor using elbow-specific, effort-dependent biomechanical measures of grip strength (pain-free and maximal), stiffness, effective mass and damping improve the radiologic appearance of several pathologic features of CLE as evaluated using imaging studies of lateral elbow structures: ultrasound to assess a) neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon stiffness ("acousto-elastic strain gauge" technique) using standardized, 0-3 severity scales, and d) MRI to assess the overall common extensor tensor tendon disease severity using a standardized 0-3 scale? provide satisfying treatment to subjects as assessed by a treatment satisfaction survey and a qualitative exit interview?

Detailed Description

CLE is a prevalent, disabling condition with significant individual and societal costs. The incidence of CLE is increasing. CLE is often refractory to care. There is limited scientific evidence to support specific therapies. PrT and PRP show promise as effective therapy for CLE that can be performed in the primary care setting. Pilot-level RCTs of PrT and PRP for CLE have reported large absolute effect sizes. Findings from invitro and animal studies are consistent with the results of clinical trials and suggest that both therapies can improve clinical outcomes and modify disease in CLE. However, prior research is limited by lack of methodological rigor, non-validated outcome measures and lack of integrated multidisciplinary outcome measures. Positive trends in the proposed study would suggest the effect size of PrT and PRP for CLE, and allow the calculation of a robust sample size to power an R01 study, and pilot test the use of an integrated set of outcome measures. Statistically significant positive results on clinical, biomechanical and radiological outcomes would demonstrate that PrT and PRP can treat, modify the disease of and may be a cure for CLE. Such findings would provide enormous benefits to patients through improved quality of life, reduced pain and disability, and to industry and society at large through reduced workers' injury claims and absenteeism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tennis Elbow

Keywords

prolotherapy, Platelet rich plasma, tennis elbow, lateral epicondylosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PrT-DMS

Arm Type

Active Comparator

Arm Description

1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.

Arm Title

PrT-D

Arm Type

Experimental

Arm Description

PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine

Arm Title

Waitlist

Arm Type

No Intervention

Arm Title

Platelet rich plasma

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Dextrose prolotherapy

Other Intervention Name(s)

dextrose

Intervention Description

PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine

Intervention Type

Procedure

Intervention Name(s)

PrT-DMS

Other Intervention Name(s)

Dextrose and Morrhuate sodium PrT

Intervention Description

PrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.

Intervention Type

Procedure

Intervention Name(s)

Platelet Rich Plasma injection

Other Intervention Name(s)

Platelet rich plasma

Intervention Description

Platelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues.

Primary Outcome Measure Information:

Title

Patient rated tennis elbow evaluation (PRTEE)

Description

Time Frame

0, 16 and 32 weeks

Secondary Outcome Measure Information:

Title

Biomedical (grip strength), ultrasound (US) and magnetic resonance imaging (MRI)

Description

Time Frame

0 and 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18-65 years diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor muscle provocation tests self-reported CLE-related pain for at least 6 months self-reported failure of at least 2 of the 3 most common treatments for CLE (a course of NSAIDS, physical therapy or corticosteroid injections). Exclusion Criteria: current bilateral CLE a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy current use of opioids for pain anticoagulation or immunosuppressive therapy in the prior month intent to use NSAIDs or steroids known allergy to dextrose, acetaminophen or lidocaine MRI contraindications: non-compatible metal in the CLE-affected upper extremity or severe claustrophobia unresolved litigation self-reported pregnancy. Pregnant women are excluded from the study because pregnancy changes the characteristics of connective tissue including ligaments and tendons associated with CLE and, so, is an unacceptable confounder in this pilot level study. There is no report however, about dextrose, morrhuate sodium or PrT being harmful to pregnant women. Therefore we will not draw confirmatory labs to ensure that women of childbearing age are not pregnant. Rather we will accept self-report on pregnancy status at the time of consent. If a woman becomes pregnant during the study she will be dropped from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David P Rabago, MD

Organizational Affiliation

University of Wisconsin, Department of Family Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Wilson, MD

Organizational Affiliation

UW Dept of Family Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northeast Family Medical Center

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

Facility Name

University of Wisconsin General Clinical Research Center

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.fammed.wisc.edu

Description

University of Wisconsin Department of Family Medicine

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Efficacy of Injection Therapy for Lateral Epicondylosis

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