Trial Outcomes & Findings for Prolotherapy for the Treatment of Chronic Lateral Epicondylitis (NCT NCT00674622)
NCT ID: NCT00674622
Last Updated: 2016-05-16
Results Overview
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.
COMPLETED
PHASE2/PHASE3
67 participants
6 weeks and 12 weeks post intervention
2016-05-16
Participant Flow
Recruitment took place between 3/17/2008 to 3/15/2010. All patients were seen at the University of Pittsburgh Medical Center outpatient clinics.
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.
Participant milestones
| Measure |
Group 1-Prolotherapy
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
Superficial injection with saline/lidocaine
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
Baseline characteristics by cohort
| Measure |
Group 1-Prolotherapy
n=22 Participants
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
n=22 Participants
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
n=22 Participants
Superficial injection with saline/lidocaine
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
49 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
66 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeks and 12 weeks post interventionThis 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.
Outcome measures
| Measure |
Group 1-Prolotherapy
n=22 Participants
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
n=22 Participants
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
n=22 Participants
Superficial injection with saline/lidocaine
|
|---|---|---|---|
|
McGill Pain Questionnaire
Baseline
|
16.6 units on a scale
Standard Deviation 9.0
|
15.7 units on a scale
Standard Deviation 6.4
|
14.3 units on a scale
Standard Deviation 6.2
|
|
McGill Pain Questionnaire
End of Phase 1
|
8.2 units on a scale
Standard Deviation 7.7
|
8.4 units on a scale
Standard Deviation 6.0
|
6.0 units on a scale
Standard Deviation 6.4
|
|
McGill Pain Questionnaire
End of Phase 2
|
5.6 units on a scale
Standard Deviation 5.5
|
3.7 units on a scale
Standard Deviation 3.9
|
5.4 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 6 weeks and 12 weeks post-interventionThe 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.
Outcome measures
| Measure |
Group 1-Prolotherapy
n=22 Participants
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
n=22 Participants
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
n=22 Participants
Superficial injection with saline/lidocaine
|
|---|---|---|---|
|
QuickDASH
Baseline
|
40.2 units on a scale
Standard Deviation 16.2
|
39.7 units on a scale
Standard Deviation 15.6
|
32.5 units on a scale
Standard Deviation 16.0
|
|
QuickDASH
End of Phase 1
|
18.5 units on a scale
Standard Deviation 18.6
|
21.2 units on a scale
Standard Deviation 17.3
|
16.7 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 6 weeks and 12 weeks post-interventionMaximal 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.
Outcome measures
| Measure |
Group 1-Prolotherapy
n=22 Participants
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
n=22 Participants
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
n=22 Participants
Superficial injection with saline/lidocaine
|
|---|---|---|---|
|
Grip Strength
Baseline
|
52.18 pounds
Standard Deviation 26.03
|
57.31 pounds
Standard Deviation 34.96
|
60.89 pounds
Standard Deviation 25.09
|
|
Grip Strength
End of Phase 1
|
65.28 pounds
Standard Deviation 20.89
|
67.87 pounds
Standard Deviation 30.38
|
78.54 pounds
Standard Deviation 27.07
|
|
Grip Strength
End of Phase 2
|
66.87 pounds
Standard Deviation 20.90
|
78.70 pounds
Standard Deviation 30.76
|
82.17 pounds
Standard Deviation 28.83
|
SECONDARY outcome
Timeframe: 6 and 12 weeks post-interventionThe 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.
Outcome measures
| Measure |
Group 1-Prolotherapy
n=22 Participants
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
n=22 Participants
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
n=22 Participants
Superficial injection with saline/lidocaine
|
|---|---|---|---|
|
Nirschl Pain Phase Scale
Baseline
|
5.18 units on a scale
Standard Deviation 0.66
|
5.18 units on a scale
Standard Deviation 0.85
|
5.23 units on a scale
Standard Deviation 0.92
|
|
Nirschl Pain Phase Scale
End of Phase 2
|
2.10 units on a scale
Standard Deviation 1.51
|
2.19 units on a scale
Standard Deviation 0.91
|
2.09 units on a scale
Standard Deviation 1.31
|
|
Nirschl Pain Phase Scale
End of Phase 1
|
2.86 units on a scale
Standard Deviation 1.96
|
3.17 units on a scale
Standard Deviation 1.86
|
2.32 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: 6 and 12 weeks post-interventionPressure 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.
Outcome measures
| Measure |
Group 1-Prolotherapy
n=22 Participants
Deep injection with 15% dextrose in lidocaine
|
Group 2-Deep Saline/Lidocaine
n=22 Participants
Deep injection with saline/lidocaine
|
Group 3-Superficial Saline/Lidocaine
n=22 Participants
Superficial injection with saline/lidocaine
|
|---|---|---|---|
|
Pain Threshold on Dolorimetry
Baseline
|
6.34 Pounds
Standard Deviation 2.71
|
6.37 Pounds
Standard Deviation 2.72
|
7.67 Pounds
Standard Deviation 2.85
|
|
Pain Threshold on Dolorimetry
End of Phase 1
|
8.26 Pounds
Standard Deviation 3.08
|
7.87 Pounds
Standard Deviation 3.75
|
9.81 Pounds
Standard Deviation 4.57
|
|
Pain Threshold on Dolorimetry
End of Phase 2
|
9.68 Pounds
Standard Deviation 3.05
|
10.13 Pounds
Standard Deviation 4.44
|
11.57 Pounds
Standard Deviation 5.45
|
Adverse Events
Group 3-Superficial Saline/Lidocaine
Group 1-Prolotherapy
Group 2-Deep Saline/Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ronald Glick, MD
University of Pittsburgh School of Medicine Department of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place