Trial · NCT00674622
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
NCT00674622, Phase 2, Phase 3, Completed, University of Pittsburgh; results first posted 2016-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prolotherapy for the Treatment of Chronic Lateral Epicondylitis. Trials, record NCT00674622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00674622
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
- NCT number
- NCT00674622
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Interventions
- Prolotherapy, Placebo
- First posted
- 2008-05-08
- Last updated
- 2016-05-16
- Results first posted
- 2016-05-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | McGill Pain Questionnaire | 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. |
| Secondary | QuickDASH | 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. |
| Secondary | Grip Strength | 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. |
| Secondary | Nirschl Pain Phase Scale | 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. |
| Secondary | Pain Threshold on Dolorimetry | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | McGill Pain Questionnaire | 6 weeks and 12 weeks post intervention | units on a scale | MEAN | |
| SECONDARY | QuickDASH | 6 weeks and 12 weeks post-intervention | units on a scale | MEAN | |
| SECONDARY | Grip Strength | 6 weeks and 12 weeks post-intervention | pounds | MEAN | |
| SECONDARY | Nirschl Pain Phase Scale | 6 and 12 weeks post-intervention | units on a scale | MEAN | |
| SECONDARY | Pain Threshold on Dolorimetry | 6 and 12 weeks post-intervention | Pounds | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| McGill Pain Questionnaire | Group 1-Prolotherapy | Baseline | 16.6 | Standard Deviation 9.0 | units on a scale |
| McGill Pain Questionnaire | Group 2-Deep Saline/Lidocaine | Baseline | 15.7 | Standard Deviation 6.4 | units on a scale |
| McGill Pain Questionnaire | Group 3-Superficial Saline/Lidocaine | Baseline | 14.3 | Standard Deviation 6.2 | units on a scale |
| McGill Pain Questionnaire | Group 1-Prolotherapy | End of Phase 1 | 8.2 | Standard Deviation 7.7 | units on a scale |
| McGill Pain Questionnaire | Group 2-Deep Saline/Lidocaine | End of Phase 1 | 8.4 | Standard Deviation 6.0 | units on a scale |
| McGill Pain Questionnaire | Group 3-Superficial Saline/Lidocaine | End of Phase 1 | 6.0 | Standard Deviation 6.4 | units on a scale |
| McGill Pain Questionnaire | Group 1-Prolotherapy | End of Phase 2 | 5.6 | Standard Deviation 5.5 | units on a scale |
| McGill Pain Questionnaire | Group 2-Deep Saline/Lidocaine | End of Phase 2 | 3.7 | Standard Deviation 3.9 | units on a scale |
| McGill Pain Questionnaire | Group 3-Superficial Saline/Lidocaine | End of Phase 2 | 5.4 | Standard Deviation 4.8 | units on a scale |
| QuickDASH | Group 1-Prolotherapy | Baseline | 40.2 | Standard Deviation 16.2 | units on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1-Prolotherapy | 22 | |
| Overall Study | STARTED | Group 2-Deep Saline/Lidocaine | 22 | |
| Overall Study | STARTED | Group 3-Superficial Saline/Lidocaine | 22 | |
| Overall Study | COMPLETED | Group 1-Prolotherapy | 21 | |
| Overall Study | COMPLETED | Group 2-Deep Saline/Lidocaine | 18 | |
| Overall Study | COMPLETED | Group 3-Superficial Saline/Lidocaine | 22 | |
| Overall Study | NOT COMPLETED | Group 1-Prolotherapy | 1 | |
| Overall Study | NOT COMPLETED | Group 2-Deep Saline/Lidocaine | 4 | |
| Overall Study | NOT COMPLETED | Group 3-Superficial Saline/Lidocaine | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1-Prolotherapy | ||
| Total, all-cause mortality | Group 2-Deep Saline/Lidocaine | ||
| Total, all-cause mortality | Group 3-Superficial Saline/Lidocaine | ||
| Total, other adverse events | Group 1-Prolotherapy | 0 | 22 |
| Total, other adverse events | Group 2-Deep Saline/Lidocaine | 0 | 22 |
| Total, other adverse events | Group 3-Superficial Saline/Lidocaine | 0 | 22 |
| Total, serious adverse events | Group 1-Prolotherapy | 0 | 22 |
| Total, serious adverse events | Group 2-Deep Saline/Lidocaine | 0 | 22 |
| Total, serious adverse events | Group 3-Superficial Saline/Lidocaine | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AT003969 | Prolotherapy for the treatement of chronic lateral epicondylitis | GLICK, RONALD M. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2007 to 2009 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00674622
GET https://conductscience.org/api/trials/v1/NCT00674622/results?page=2