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Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT00674622
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ronald M. Glick, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Lateral Epicondylitis
Tennis Elbow
Interventions Drug: Prolotherapy
Procedure: Placebo
Enrollment 67
Recruitment Details Recruitment took place between 3/17/2008 to 3/15/2010. All patients were seen at the University of Pittsburgh Medical Center outpatient clinics.
Pre-assignment Details

105 subjects completed informed consent.

38 subjects were ineligible, based on absence of diagnosis of lateral epicondylitis, insufficient severity of symptoms, or presence of an exclusion.

1 subject completed all assessments but declined participation and was not randomized.

Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description Deep injection with 15% dextrose in lidocaine Deep injection with saline/lidocaine Superficial injection with saline/lidocaine
Period Title: Overall Study
Started 22 22 22
Completed 21 18 22
Not Completed 1 4 0
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine Total
Hide Arm/Group Description Deep injection with 15% dextrose in lidocaine Deep injection with saline/lidocaine Superficial injection with saline/lidocaine Total of all reporting groups
Overall Number of Baseline Participants 22 22 22 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 22 participants 66 participants
49
(32 to 64)
50
(34 to 65)
50
(39 to 63)
49
(32 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 22 participants 66 participants
Female
7
  31.8%
10
  45.5%
11
  50.0%
28
  42.4%
Male
15
  68.2%
12
  54.5%
11
  50.0%
38
  57.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 22 participants 66 participants
White 18 22 22 62
Black 2 0 0 2
Asian 1 0 0 1
Hispanic 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 22 participants 66 participants
22 22 22 66
1.Primary Outcome
Title McGill Pain Questionnaire
Hide Description 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.
Time Frame 6 weeks and 12 weeks post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description:
Deep injection with 15% dextrose in lidocaine
Deep injection with saline/lidocaine
Superficial injection with saline/lidocaine
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.6  (9.0) 15.7  (6.4) 14.3  (6.2)
End of Phase 1 8.2  (7.7) 8.4  (6.0) 6.0  (6.4)
End of Phase 2 5.6  (5.5) 3.7  (3.9) 5.4  (4.8)
2.Secondary Outcome
Title QuickDASH
Hide Description 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.
Time Frame 6 weeks and 12 weeks post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description:
Deep injection with 15% dextrose in lidocaine
Deep injection with saline/lidocaine
Superficial injection with saline/lidocaine
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 40.2  (16.2) 39.7  (15.6) 32.5  (16.0)
End of Phase 1 18.5  (18.6) 21.2  (17.3) 16.7  (17.5)
3.Secondary Outcome
Title Grip Strength
Hide Description 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.
Time Frame 6 weeks and 12 weeks post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description:
Deep injection with 15% dextrose in lidocaine
Deep injection with saline/lidocaine
Superficial injection with saline/lidocaine
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: pounds
Baseline 52.18  (26.03) 57.31  (34.96) 60.89  (25.09)
End of Phase 1 65.28  (20.89) 67.87  (30.38) 78.54  (27.07)
End of Phase 2 66.87  (20.90) 78.70  (30.76) 82.17  (28.83)
4.Secondary Outcome
Title Nirschl Pain Phase Scale
Hide Description 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.
Time Frame 6 and 12 weeks post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description:
Deep injection with 15% dextrose in lidocaine
Deep injection with saline/lidocaine
Superficial injection with saline/lidocaine
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.18  (0.66) 5.18  (0.85) 5.23  (0.92)
End of Phase 1 2.86  (1.96) 3.17  (1.86) 2.32  (1.39)
End of Phase 2 2.10  (1.51) 2.19  (0.91) 2.09  (1.31)
5.Secondary Outcome
Title Pain Threshold on Dolorimetry
Hide Description 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.
Time Frame 6 and 12 weeks post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description:
Deep injection with 15% dextrose in lidocaine
Deep injection with saline/lidocaine
Superficial injection with saline/lidocaine
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: Pounds
Baseline 6.34  (2.71) 6.37  (2.72) 7.67  (2.85)
End of Phase 1 8.26  (3.08) 7.87  (3.75) 9.81  (4.57)
End of Phase 2 9.68  (3.05) 10.13  (4.44) 11.57  (5.45)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Hide Arm/Group Description Deep injection with 15% dextrose in lidocaine Deep injection with saline/lidocaine Superficial injection with saline/lidocaine
All-Cause Mortality
Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1-Prolotherapy Group 2-Deep Saline/Lidocaine Group 3-Superficial Saline/Lidocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ronald Glick, MD
Organization: University of Pittsburgh School of Medicine Department of Psychiatry
Phone: 412-623-3023
EMail: glickrm@upmc.edu
Layout table for additonal information
Responsible Party: Ronald M. Glick, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00674622    
Other Study ID Numbers: 1R21AT003969-01A1 ( U.S. NIH Grant/Contract )
1R21AT003969-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2008
First Posted: May 8, 2008
Results First Submitted: January 8, 2016
Results First Posted: May 16, 2016
Last Update Posted: May 16, 2016