Efficacy of Injection Therapy for Lateral Epicondylosis
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Dextrose prolotherapy; PrT-DMS; Platelet Rich Plasma injection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine; PrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.; Platelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues.
Other intervention name(s): dextrose; Dextrose and Morrhuate sodium PrT; Platelet rich plasma
Intervention MeSH terms: Sodium Morrhuate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prolotherapy; Platelet rich plasma; tennis elbow; lateral epicondylosis