Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
|ClinicalTrials.gov Identifier: NCT00674622|
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis Tennis Elbow||Drug: Prolotherapy Procedure: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Prolotherapy for the Treatment of Chronic Lateral Epicondylitis|
|Study Start Date :||September 2007|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2011|
Experimental: Group 1-Prolotherapy
Deep injection with 15% dextrose in lidocaine
Injection of 15% dextrose with lidocaine at the lateral epicondyle
Placebo Comparator: Group 2-Deep Saline/Lidocaine
Deep injection with saline/lidocaine
Placebo Comparator: Group 3-Superficial Saline/lidocaine
Superficial injection with saline/lidocaine
- McGill Pain Questionnaire [ Time Frame: 6 weeks and 12 weeks post intervention ]This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.
- QuickDASH [ Time Frame: 6 weeks and 12 weeks post-intervention ]The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, & Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire "Disabilities of the Arm, Shoulder, & Hand". It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability.
- Grip Strength [ Time Frame: 6 weeks and 12 weeks post-intervention ]Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.
- Nirschl Pain Phase Scale [ Time Frame: 6 and 12 weeks post-intervention ]The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting "No stiffness or soreness after activity" and Phase 7 corresponding with "Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity". It was used as an indication of severity for entry into the study and as the criterion for treatment response.
- Pain Threshold on Dolorimetry [ Time Frame: 6 and 12 weeks post-intervention ]Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674622
|United States, Pennsylvania|
|Center for Integrative Medicine at UPMC Shadyside|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ronald M Glick, MD||University of Pittsburgh|