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Efficacy of Injection Therapy for Lateral Epicondylosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476605
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : February 18, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE November 22, 2011
Last Update Posted Date February 18, 2019
Study Start Date  ICMJE June 2009
Actual Primary Completion Date November 1, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
Patient rated tennis elbow evaluation (PRTEE) [ Time Frame: 0, 16 and 32 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
Biomedical (grip strength), ultrasound (US) and magnetic resonance imaging (MRI) [ Time Frame: 0 and 16 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of Injection Therapy for Lateral Epicondylosis
Official Title  ICMJE The Efficacy of Prolotherapy and Platelet Rich Plasma Injections for Lateral Epicondylosis: a Pilot Study
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. 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. 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. 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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tennis Elbow
Intervention  ICMJE
  • Procedure: Dextrose prolotherapy
    PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine
    Other Name: dextrose
  • Procedure: PrT-DMS
    PrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.
    Other Name: Dextrose and Morrhuate sodium PrT
  • Procedure: Platelet Rich Plasma injection
    Platelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues.
    Other Name: Platelet rich plasma
Study Arms  ICMJE
  • Active Comparator: PrT-DMS
    1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.
    Intervention: Procedure: PrT-DMS
  • Experimental: PrT-D
    PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine
    Intervention: Procedure: Dextrose prolotherapy
  • No Intervention: Waitlist
  • Active Comparator: Platelet rich plasma
    Intervention: Procedure: Platelet Rich Plasma injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2011)
Actual Study Completion Date  ICMJE December 1, 2015
Actual Primary Completion Date November 1, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age 18-65 years
  2. 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
  3. self-reported CLE-related pain for at least 6 months
  4. 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:

  1. current bilateral CLE
  2. a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
  3. current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity
  4. self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy
  5. current use of opioids for pain
  6. anticoagulation or immunosuppressive therapy in the prior month
  7. intent to use NSAIDs or steroids
  8. known allergy to dextrose, acetaminophen or lidocaine
  9. MRI contraindications: non-compatible metal in the CLE-affected upper extremity or severe claustrophobia
  10. unresolved litigation
  11. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01476605
Other Study ID Numbers  ICMJE H-2008-0148
G0810 ( Other Grant/Funding Number: American Academy of Family Physicians-Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David P Rabago, MD University of Wisconsin, Department of Family Medicine
Principal Investigator: John Wilson, MD UW Dept of Family Medicine
PRS Account University of Wisconsin, Madison
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP