Lateral Epicondylitis
Conditions
Keywords
elbow
Brief summary
The purpose of this study is to determine whether recombinant human platelet-derived growth factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis elbow).
Detailed description
Methodology: Randomized, single ascending dose, double-blinded, placebo controlled, multi-center study Study Center(s): 6 Number of Subjects: 100 Diagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80 years of age Study Drug, Dose, Regimen: Dose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer + 1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB Duration and Route of Administration: Single administration dose by injection into the extensor carpi radialis brevis (ECRB) Duration of Follow-up: 24 weeks (6 months) post-operative follow-up
Interventions
DRUGrhPDGF-BB Injection
Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
DRUGPlacebo
sodium acetate buffer (0 mg rhPDGF-BB)
Sponsors
BioMimetic Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has signed the Institutional Review Board (IRB) approved Informed Consent Form specific to this study prior to enrollment 2. Subject has a clinical diagnosis of lateral epicondylitis 3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion 4. Subject's symptoms have persisted for at least 3 months despite conservative treatment that includes one or combinations of: 1. Physical therapy 2. Splinting 3. Nonsteroidal antiinflammatory drug (NSAID) 4. Corticosteroid injection 5. Subject is independent, ambulatory, and can comply with all post-injection evaluations and visits 6. Subject is 21-80 years of age and considered to be skeletally mature
Exclusion criteria
1. Subject has undergone previous corticosteroid injection therapy to the effected elbow in less than three months prior to enrollment 2. Subject has received previous Platelet Rich Plasma (PRP) injection to the affected elbow 3. Subject is deemed to require a corticosteroid injection into the affected elbow during the course of the study 4. Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \>10mg/day) 5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis 6. Subject has a positive medical history of any of the following: 1. medial epicondylitis 2. radial tunnel syndrome 3. carpal tunnel syndrome 4. septic or gouty arthritis 5. cervical radiculopathy 6. trauma to the affected elbow within the past 6 weeks 7. neuromuscular or musculoskeletal deficiency, which limits the ability to perform functional measurement (e.g. grip strength test) 7. Subject currently has an acute infection at the injection site 8. Subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed rhPDGF-BB Injection treatment site 9. Subject is physically or mentally compromised (e.g. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant 10. Subject has an allergy to yeast-derived products 11. Subject has received an investigational therapy or approved therapy for investigational use within 30 days of injection procedure or during the follow-up phase of this study 12. Subject is a prisoner, or is known or suspected to be transient 13. Subject's condition represents a worker's compensation case 14. Subject is currently involved in a health-related litigation procedure 15. Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry 16. Subject is pregnant, or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elbow Pain Assessments (VAS), Treated Subjects | Baseline, 2, 4, 8, 12, and 24 weeks | Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). |
| Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Baseline, 4, 8, 12, and 24 weeks | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. |
| Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Baseline, 4, 8, 12, and 24 weeks | The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as tennis elbow). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) -Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) * Specific activities - 6 items * Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally |
| Grip Strength Test, All Treated Subjects | Baseline, 4, 8, 12, and 24 weeks | Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis. |
| Maximum Grip Strength, Treated Subjects | Baseline, 4, 8, 12, and 24 weeks | A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Control Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 20 |
| 0.45 mg rhPDGF-BB Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 20 |
| 0.75 mg rhPDGF-BB Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 20 |
| 1.5 mg rhPDGF-BB Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 20 |
| 3.0 mg rhPDGF-BB Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 20 |
| Total | 100 |
Baseline characteristics
| Characteristic | Placebo Control | Total | 3.0 mg rhPDGF-BB | 1.5 mg rhPDGF-BB | 0.75 mg rhPDGF-BB | 0.45 mg rhPDGF-BB |
|---|---|---|---|---|---|---|
| Age, Customized Age | 44.2 years STANDARD_DEVIATION 7.1 | 47.1 years STANDARD_DEVIATION 8.6 | 49 years STANDARD_DEVIATION 8.3 | 47.4 years STANDARD_DEVIATION 12.4 | 46 years STANDARD_DEVIATION 7 | 49 years STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 89 Participants | 15 Participants | 17 Participants | 20 Participants | 19 Participants |
| Sex: Female, Male Female | 12 Participants | 51 Participants | 9 Participants | 10 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 49 Participants | 11 Participants | 10 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 20 | 20 / 20 | 18 / 20 | 16 / 20 | 18 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 2 / 20 | 0 / 20 | 1 / 20 |
Outcome results
Primary
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Time frame: Baseline, 4, 8, 12, and 24 weeks
Population: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 12 | 12.6 score on a scale | Standard Deviation 8.6 |
| Placebo Control | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Baseline | 43.7 score on a scale | Standard Deviation 13.9 |
| Placebo Control | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 24 | 7.2 score on a scale | Standard Deviation 9.6 |
| Placebo Control | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 4 | 29.2 score on a scale | Standard Deviation 12.5 |
| Placebo Control | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 8 | 21.8 score on a scale | Standard Deviation 11.5 |
| 0.45 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 12 | 16.7 score on a scale | Standard Deviation 13.2 |
| 0.45 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 8 | 23 score on a scale | Standard Deviation 14.2 |
| 0.45 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 4 | 30.9 score on a scale | Standard Deviation 12.8 |
| 0.45 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 24 | 11.4 score on a scale | Standard Deviation 9.9 |
| 0.45 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Baseline | 43.5 score on a scale | Standard Deviation 13.5 |
| 0.75 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 8 | 24.7 score on a scale | Standard Deviation 14.9 |
| 0.75 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Baseline | 40.1 score on a scale | Standard Deviation 19.8 |
| 0.75 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 4 | 34.1 score on a scale | Standard Deviation 18.3 |
| 0.75 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 12 | 19.8 score on a scale | Standard Deviation 15.3 |
| 0.75 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 24 | 14.5 score on a scale | Standard Deviation 17.3 |
| 1.5 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 24 | 13.8 score on a scale | Standard Deviation 15.6 |
| 1.5 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Baseline | 40 score on a scale | Standard Deviation 15.3 |
| 1.5 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 12 | 16.1 score on a scale | Standard Deviation 15.9 |
| 1.5 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 8 | 19.7 score on a scale | Standard Deviation 16.4 |
| 1.5 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 4 | 27.8 score on a scale | Standard Deviation 20.2 |
| 3.0 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 8 | 25.1 score on a scale | Standard Deviation 22.5 |
| 3.0 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 12 | 24.5 score on a scale | Standard Deviation 23.7 |
| 3.0 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Baseline | 41.3 score on a scale | Standard Deviation 18.5 |
| 3.0 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 24 | 19.6 score on a scale | Standard Deviation 24.3 |
| 3.0 mg rhPDGF-BB | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | Week 4 | 38.3 score on a scale | Standard Deviation 22.9 |
Primary
Elbow Pain Assessments (VAS), Treated Subjects
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Time frame: Baseline, 2, 4, 8, 12, and 24 weeks
Population: Analysis conducted on patients at Baseline, 2, 4, 8, 12, and 24 weeks time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Elbow Pain Assessments (VAS), Treated Subjects | Week 8 | 35.9 score on a scale | Standard Deviation 23.4 |
| Placebo Control | Elbow Pain Assessments (VAS), Treated Subjects | Week 2 | 67.1 score on a scale | Standard Deviation 15 |
| Placebo Control | Elbow Pain Assessments (VAS), Treated Subjects | Week 24 | 16.9 score on a scale | Standard Deviation 21 |
| Placebo Control | Elbow Pain Assessments (VAS), Treated Subjects | Baseline | 76.6 score on a scale | Standard Deviation 14.4 |
| Placebo Control | Elbow Pain Assessments (VAS), Treated Subjects | Week 12 | 28.7 score on a scale | Standard Deviation 20.2 |
| Placebo Control | Elbow Pain Assessments (VAS), Treated Subjects | Week 4 | 49.9 score on a scale | Standard Deviation 18 |
| 0.45 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 8 | 39.7 score on a scale | Standard Deviation 19.5 |
| 0.45 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 4 | 49.8 score on a scale | Standard Deviation 21.1 |
| 0.45 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Baseline | 77.7 score on a scale | Standard Deviation 9.2 |
| 0.45 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 24 | 23.1 score on a scale | Standard Deviation 25.6 |
| 0.45 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 12 | 31.2 score on a scale | Standard Deviation 21.6 |
| 0.45 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 2 | 73.2 score on a scale | Standard Deviation 14.6 |
| 0.75 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 4 | 55.5 score on a scale | Standard Deviation 27 |
| 0.75 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Baseline | 75.9 score on a scale | Standard Deviation 16.9 |
| 0.75 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 2 | 78.5 score on a scale | Standard Deviation 18.4 |
| 0.75 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 8 | 47.2 score on a scale | Standard Deviation 20.8 |
| 0.75 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 12 | 36.7 score on a scale | Standard Deviation 25.3 |
| 0.75 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 24 | 28.5 score on a scale | Standard Deviation 26 |
| 1.5 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 2 | 59.7 score on a scale | Standard Deviation 22.7 |
| 1.5 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Baseline | 72 score on a scale | Standard Deviation 19.9 |
| 1.5 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 4 | 40.2 score on a scale | Standard Deviation 24.1 |
| 1.5 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 24 | 23.8 score on a scale | Standard Deviation 28.2 |
| 1.5 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 12 | 29.8 score on a scale | Standard Deviation 29.7 |
| 1.5 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 8 | 33 score on a scale | Standard Deviation 27.2 |
| 3.0 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 24 | 32.1 score on a scale | Standard Deviation 31.4 |
| 3.0 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 8 | 39.1 score on a scale | Standard Deviation 28.8 |
| 3.0 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Baseline | 72.2 score on a scale | Standard Deviation 20.6 |
| 3.0 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 12 | 40.4 score on a scale | Standard Deviation 29 |
| 3.0 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 4 | 52.5 score on a scale | Standard Deviation 27.3 |
| 3.0 mg rhPDGF-BB | Elbow Pain Assessments (VAS), Treated Subjects | Week 2 | 70 score on a scale | Standard Deviation 26.6 |
Primary
Grip Strength Test, All Treated Subjects
Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.
Time frame: Baseline, 4, 8, 12, and 24 weeks
Population: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Grip Strength Test, All Treated Subjects | Week 12 | 58.2 lbs. | Standard Deviation 28.1 |
| Placebo Control | Grip Strength Test, All Treated Subjects | Baseline | 42.6 lbs. | Standard Deviation 30.1 |
| Placebo Control | Grip Strength Test, All Treated Subjects | Week 24 | 66.4 lbs. | Standard Deviation 26.4 |
| Placebo Control | Grip Strength Test, All Treated Subjects | Week 4 | 40.2 lbs. | Standard Deviation 25.6 |
| Placebo Control | Grip Strength Test, All Treated Subjects | Week 8 | 53.5 lbs. | Standard Deviation 27.8 |
| 0.45 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 12 | 61 lbs. | Standard Deviation 37.7 |
| 0.45 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 8 | 50.6 lbs. | Standard Deviation 36.3 |
| 0.45 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 4 | 44.5 lbs. | Standard Deviation 32 |
| 0.45 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 24 | 69.1 lbs. | Standard Deviation 37.5 |
| 0.45 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Baseline | 33.4 lbs. | Standard Deviation 24.1 |
| 0.75 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 8 | 64.6 lbs. | Standard Deviation 35 |
| 0.75 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Baseline | 47.6 lbs. | Standard Deviation 29.4 |
| 0.75 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 4 | 48.3 lbs. | Standard Deviation 33 |
| 0.75 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 12 | 67.5 lbs. | Standard Deviation 38.3 |
| 0.75 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 24 | 79.9 lbs. | Standard Deviation 33.4 |
| 1.5 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 24 | 69.9 lbs. | Standard Deviation 29.1 |
| 1.5 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Baseline | 39.6 lbs. | Standard Deviation 28.9 |
| 1.5 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 12 | 61.1 lbs. | Standard Deviation 32.1 |
| 1.5 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 8 | 53.3 lbs. | Standard Deviation 29 |
| 1.5 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 4 | 52 lbs. | Standard Deviation 30.2 |
| 3.0 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 8 | 54.8 lbs. | Standard Deviation 26.4 |
| 3.0 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 12 | 45.1 lbs. | Standard Deviation 25.3 |
| 3.0 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Baseline | 39.7 lbs. | Standard Deviation 23.2 |
| 3.0 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 24 | 62.9 lbs. | Standard Deviation 25.7 |
| 3.0 mg rhPDGF-BB | Grip Strength Test, All Treated Subjects | Week 4 | 41.9 lbs. | Standard Deviation 26.3 |
Primary
Maximum Grip Strength, Treated Subjects
A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.
Time frame: Baseline, 4, 8, 12, and 24 weeks
Population: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Maximum Grip Strength, Treated Subjects | Week 12 | 78.9 lbs. | Standard Deviation 29.9 |
| Placebo Control | Maximum Grip Strength, Treated Subjects | Baseline | 60.4 lbs. | Standard Deviation 35 |
| Placebo Control | Maximum Grip Strength, Treated Subjects | Week 24 | 82.5 lbs. | Standard Deviation 32.7 |
| Placebo Control | Maximum Grip Strength, Treated Subjects | Week 4 | 62.9 lbs. | Standard Deviation 26.2 |
| Placebo Control | Maximum Grip Strength, Treated Subjects | Week 8 | 73.3 lbs. | Standard Deviation 29.3 |
| 0.45 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 12 | 68.6 lbs. | Standard Deviation 31.2 |
| 0.45 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 8 | 66.4 lbs. | Standard Deviation 31.3 |
| 0.45 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 4 | 63.5 lbs. | Standard Deviation 33.1 |
| 0.45 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 24 | 71 lbs. | Standard Deviation 32.5 |
| 0.45 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Baseline | 58.7 lbs. | Standard Deviation 33.1 |
| 0.75 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 8 | 72.9 lbs. | Standard Deviation 37 |
| 0.75 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Baseline | 71.8 lbs. | Standard Deviation 38.9 |
| 0.75 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 4 | 64.2 lbs. | Standard Deviation 37.2 |
| 0.75 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 12 | 81.8 lbs. | Standard Deviation 39.7 |
| 0.75 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 24 | 80.7 lbs. | Standard Deviation 33.7 |
| 1.5 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 24 | 77.8 lbs. | Standard Deviation 27 |
| 1.5 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Baseline | 60.3 lbs. | Standard Deviation 31.2 |
| 1.5 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 12 | 74.5 lbs. | Standard Deviation 32.8 |
| 1.5 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 8 | 71.6 lbs. | Standard Deviation 30 |
| 1.5 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 4 | 68.9 lbs. | Standard Deviation 35.5 |
| 3.0 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 8 | 66.9 lbs. | Standard Deviation 31.5 |
| 3.0 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 12 | 65.1 lbs. | Standard Deviation 30 |
| 3.0 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Baseline | 61.3 lbs. | Standard Deviation 29.7 |
| 3.0 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 24 | 76.4 lbs. | Standard Deviation 30.9 |
| 3.0 mg rhPDGF-BB | Maximum Grip Strength, Treated Subjects | Week 4 | 62 lbs. | Standard Deviation 33 |
Primary
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as tennis elbow). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) -Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) * Specific activities - 6 items * Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally
Time frame: Baseline, 4, 8, 12, and 24 weeks
Population: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 24 | 7.8 score on a scale | Standard Deviation 10 |
| Placebo Control | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 4 | 34.7 score on a scale | Standard Deviation 14.5 |
| Placebo Control | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 12 | 13.5 score on a scale | Standard Deviation 8 |
| Placebo Control | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 8 | 25.2 score on a scale | Standard Deviation 15.2 |
| Placebo Control | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Baseline | 52.6 score on a scale | Standard Deviation 17.9 |
| 0.45 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 4 | 39.2 score on a scale | Standard Deviation 15.3 |
| 0.45 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 12 | 18.2 score on a scale | Standard Deviation 16.4 |
| 0.45 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Baseline | 56 score on a scale | Standard Deviation 14.3 |
| 0.45 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 24 | 12.1 score on a scale | Standard Deviation 12.4 |
| 0.45 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 8 | 26.9 score on a scale | Standard Deviation 17.4 |
| 0.75 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 8 | 28.9 score on a scale | Standard Deviation 15.1 |
| 0.75 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 12 | 22.3 score on a scale | Standard Deviation 16.4 |
| 0.75 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 24 | 16.2 score on a scale | Standard Deviation 17.9 |
| 0.75 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 4 | 39.3 score on a scale | Standard Deviation 21.7 |
| 0.75 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Baseline | 48.3 score on a scale | Standard Deviation 16.3 |
| 1.5 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 12 | 20.1 score on a scale | Standard Deviation 22.7 |
| 1.5 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Baseline | 52.6 score on a scale | Standard Deviation 20.7 |
| 1.5 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 4 | 32.2 score on a scale | Standard Deviation 23.9 |
| 1.5 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 8 | 25.4 score on a scale | Standard Deviation 21 |
| 1.5 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 24 | 16.8 score on a scale | Standard Deviation 19.3 |
| 3.0 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 8 | 28.6 score on a scale | Standard Deviation 24.9 |
| 3.0 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 4 | 43.4 score on a scale | Standard Deviation 24.3 |
| 3.0 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Baseline | 52.3 score on a scale | Standard Deviation 22.9 |
| 3.0 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 24 | 22.3 score on a scale | Standard Deviation 27.3 |
| 3.0 mg rhPDGF-BB | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | Week 12 | 26.8 score on a scale | Standard Deviation 24.8 |