NCT01476605

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:

  1. 1.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?
  2. 2.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
  3. 3.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?
  4. 4.provide satisfying treatment to subjects as assessed by a treatment satisfaction survey and a qualitative exit interview?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

October 25, 2011

Last Update Submit

February 14, 2019

Conditions

Tennis Elbow

Keywords

prolotherapyPlatelet rich plasmatennis elbowlateral epicondylosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    0, 16 and 32 weeks

Secondary Outcomes (1)

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

    0 and 16 weeks

Study Arms (4)

PrT-DMS

ACTIVE COMPARATOR

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

Procedure: PrT-DMS

PrT-D

EXPERIMENTAL

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

Procedure: Dextrose prolotherapy

Waitlist

NO INTERVENTION

Platelet rich plasma

ACTIVE COMPARATOR
Procedure: Platelet Rich Plasma injection

Interventions

Dextrose prolotherapyPROCEDURE

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

Also known as: dextrose
PrT-D
PrT-DMSPROCEDURE

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

Also known as: Dextrose and Morrhuate sodium PrT
PrT-DMS
Platelet Rich Plasma injectionPROCEDURE

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

Also known as: Platelet rich plasma
Platelet rich plasma

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northeast Family Medical Center

Madison, Wisconsin, 53704, United States

Location

University of Wisconsin General Clinical Research Center

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Tennis Elbow

Interventions

Glucose

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • David P Rabago, MD

    University of Wisconsin, Department of Family Medicine

    PRINCIPAL INVESTIGATOR

  • John Wilson, MD

    UW Dept of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 22, 2011

Study Start

June 1, 2009

Primary Completion

November 1, 2011

Study Completion

December 1, 2015

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

US(2)