Lateral Epicondylitis, Tennis Elbow
Conditions
Keywords
Lateral epicondylitis, Tennis elbow, Prolotherapy
Brief summary
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.
Detailed description
Same
Interventions
DRUGProlotherapy
Injection of 15% dextrose with lidocaine at the lateral epicondyle
PROCEDUREPlacebo
Saline/lidocaine
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18-65, as younger individuals are more likely to have other developmental conditions and older individuals are more likely to have a significant arthritic component to their elbow pain; 2. Ability to speak, read, and write English; 3. Unilateral or bilateral lateral elbow pain associated with findings on exam consistent with LE and absence of other conditions that can mimic LE such as radial tunnel syndrome. 4. Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.
Exclusion criteria
1. Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome; 2. Prior surgery of the involved elbow; 3. Known allergy to lidocaine or dextrose; 4. Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT. 5. Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections; 6. Ongoing treatment with systemic corticosteroids or immunosuppressant medications, as they may block a potential immune mechanism of the PrT and increase the risk for infection; 7. Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT; 8. Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections; 9. Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections; 10. Pregnancy-as there is no research documenting safety of PrT during pregnancy; 11. Medical necessity for taking ongoing nonsteroidal anti-inflammatory medication, beyond 1 aspirin per day for cardiac prevention, as this may diminish the effect of PrT; 12. Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT. 13. Prior treatment with PrT for any condition, as this may impact on blinding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Group 1-Prolotherapy Deep injection with 15% dextrose in lidocaine | 22 |
| Group 2-Deep Saline/Lidocaine Deep injection with saline/lidocaine | 22 |
| Group 3-Superficial Saline/Lidocaine Superficial injection with saline/lidocaine | 22 |
| Total | 66 |
Baseline characteristics
| Characteristic | Group 1-Prolotherapy | Group 2-Deep Saline/Lidocaine | Group 3-Superficial Saline/Lidocaine | Total |
|---|---|---|---|---|
| Age, Continuous | 49 years | 50 years | 50 years | 49 years |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 2 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 18 participants | 22 participants | 22 participants | 62 participants |
| Region of Enrollment United States | 22 participants | 22 participants | 22 participants | 66 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 11 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
McGill Pain Questionnaire
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Prolotherapy | McGill Pain Questionnaire | End of Phase 2 | 5.6 units on a scale | Standard Deviation 5.5 |
| Group 1-Prolotherapy | McGill Pain Questionnaire | End of Phase 1 | 8.2 units on a scale | Standard Deviation 7.7 |
| Group 1-Prolotherapy | McGill Pain Questionnaire | Baseline | 16.6 units on a scale | Standard Deviation 9 |
| Group 2-Deep Saline/Lidocaine | McGill Pain Questionnaire | End of Phase 2 | 3.7 units on a scale | Standard Deviation 3.9 |
| Group 2-Deep Saline/Lidocaine | McGill Pain Questionnaire | Baseline | 15.7 units on a scale | Standard Deviation 6.4 |
| Group 2-Deep Saline/Lidocaine | McGill Pain Questionnaire | End of Phase 1 | 8.4 units on a scale | Standard Deviation 6 |
| Group 3-Superficial Saline/Lidocaine | McGill Pain Questionnaire | End of Phase 1 | 6.0 units on a scale | Standard Deviation 6.4 |
| Group 3-Superficial Saline/Lidocaine | McGill Pain Questionnaire | Baseline | 14.3 units on a scale | Standard Deviation 6.2 |
| Group 3-Superficial Saline/Lidocaine | McGill Pain Questionnaire | End of Phase 2 | 5.4 units on a scale | Standard Deviation 4.8 |
Secondary
Grip Strength
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Prolotherapy | Grip Strength | End of Phase 1 | 65.28 pounds | Standard Deviation 20.89 |
| Group 1-Prolotherapy | Grip Strength | Baseline | 52.18 pounds | Standard Deviation 26.03 |
| Group 1-Prolotherapy | Grip Strength | End of Phase 2 | 66.87 pounds | Standard Deviation 20.9 |
| Group 2-Deep Saline/Lidocaine | Grip Strength | End of Phase 1 | 67.87 pounds | Standard Deviation 30.38 |
| Group 2-Deep Saline/Lidocaine | Grip Strength | Baseline | 57.31 pounds | Standard Deviation 34.96 |
| Group 2-Deep Saline/Lidocaine | Grip Strength | End of Phase 2 | 78.70 pounds | Standard Deviation 30.76 |
| Group 3-Superficial Saline/Lidocaine | Grip Strength | Baseline | 60.89 pounds | Standard Deviation 25.09 |
| Group 3-Superficial Saline/Lidocaine | Grip Strength | End of Phase 2 | 82.17 pounds | Standard Deviation 28.83 |
| Group 3-Superficial Saline/Lidocaine | Grip Strength | End of Phase 1 | 78.54 pounds | Standard Deviation 27.07 |
Secondary
Nirschl Pain Phase Scale
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Prolotherapy | Nirschl Pain Phase Scale | Baseline | 5.18 units on a scale | Standard Deviation 0.66 |
| Group 1-Prolotherapy | Nirschl Pain Phase Scale | End of Phase 1 | 2.86 units on a scale | Standard Deviation 1.96 |
| Group 1-Prolotherapy | Nirschl Pain Phase Scale | End of Phase 2 | 2.10 units on a scale | Standard Deviation 1.51 |
| Group 2-Deep Saline/Lidocaine | Nirschl Pain Phase Scale | Baseline | 5.18 units on a scale | Standard Deviation 0.85 |
| Group 2-Deep Saline/Lidocaine | Nirschl Pain Phase Scale | End of Phase 1 | 3.17 units on a scale | Standard Deviation 1.86 |
| Group 2-Deep Saline/Lidocaine | Nirschl Pain Phase Scale | End of Phase 2 | 2.19 units on a scale | Standard Deviation 0.91 |
| Group 3-Superficial Saline/Lidocaine | Nirschl Pain Phase Scale | End of Phase 1 | 2.32 units on a scale | Standard Deviation 1.39 |
| Group 3-Superficial Saline/Lidocaine | Nirschl Pain Phase Scale | End of Phase 2 | 2.09 units on a scale | Standard Deviation 1.31 |
| Group 3-Superficial Saline/Lidocaine | Nirschl Pain Phase Scale | Baseline | 5.23 units on a scale | Standard Deviation 0.92 |
Secondary
Pain Threshold on Dolorimetry
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Prolotherapy | Pain Threshold on Dolorimetry | Baseline | 6.34 Pounds | Standard Deviation 2.71 |
| Group 1-Prolotherapy | Pain Threshold on Dolorimetry | End of Phase 2 | 9.68 Pounds | Standard Deviation 3.05 |
| Group 1-Prolotherapy | Pain Threshold on Dolorimetry | End of Phase 1 | 8.26 Pounds | Standard Deviation 3.08 |
| Group 2-Deep Saline/Lidocaine | Pain Threshold on Dolorimetry | End of Phase 1 | 7.87 Pounds | Standard Deviation 3.75 |
| Group 2-Deep Saline/Lidocaine | Pain Threshold on Dolorimetry | Baseline | 6.37 Pounds | Standard Deviation 2.72 |
| Group 2-Deep Saline/Lidocaine | Pain Threshold on Dolorimetry | End of Phase 2 | 10.13 Pounds | Standard Deviation 4.44 |
| Group 3-Superficial Saline/Lidocaine | Pain Threshold on Dolorimetry | End of Phase 2 | 11.57 Pounds | Standard Deviation 5.45 |
| Group 3-Superficial Saline/Lidocaine | Pain Threshold on Dolorimetry | Baseline | 7.67 Pounds | Standard Deviation 2.85 |
| Group 3-Superficial Saline/Lidocaine | Pain Threshold on Dolorimetry | End of Phase 1 | 9.81 Pounds | Standard Deviation 4.57 |
Secondary
QuickDASH
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Prolotherapy | QuickDASH | Baseline | 40.2 units on a scale | Standard Deviation 16.2 |
| Group 1-Prolotherapy | QuickDASH | End of Phase 1 | 18.5 units on a scale | Standard Deviation 18.6 |
| Group 2-Deep Saline/Lidocaine | QuickDASH | Baseline | 39.7 units on a scale | Standard Deviation 15.6 |
| Group 2-Deep Saline/Lidocaine | QuickDASH | End of Phase 1 | 21.2 units on a scale | Standard Deviation 17.3 |
| Group 3-Superficial Saline/Lidocaine | QuickDASH | Baseline | 32.5 units on a scale | Standard Deviation 16 |
| Group 3-Superficial Saline/Lidocaine | QuickDASH | End of Phase 1 | 16.7 units on a scale | Standard Deviation 17.5 |