| ID | Type | Description | Link |
|---|---|---|---|
| Research Seed Grant # 1204 | Other Grant/Funding Number | Radiological Society of North America (RSNA) |
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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
| The Physicians' Services Incorporated Foundation | OTHER |
| Radiological Society of North America | OTHER |
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"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.
Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique.
At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment.
The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma (PRP) Injection | Experimental | Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. |
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| Whole Blood Injection | Active Comparator | Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. |
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| Dry Needle Fenestration | Active Comparator | Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon. |
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| Sham Injection | Placebo Comparator | Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) Injection | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction | Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain). | Baseline, 6 weeks, 3, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Disability | Functional disability will be measured using the Liverpool Elbow Score (LES) which is an assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities. | Baseline, 6 weeks, 3, 6, 12, 24 months |
| Psychological Impairment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary M Chiavaras, MD, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109-5326 | United States | ||
| Hamilton General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34590307 | Derived | Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2. |
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| Whole Blood Injection | Other |
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| Dry Needle Fenestration | Other |
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| Sham Injection | Other |
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Psychological impairment (depression and anxiety) will be assessed using the Hospital Anxiety and Depression Scale (HADS) which is a reliable, validated, and practical tool for identifying and quantifying anxiety and depression. |
| Baseline, 6 weeks, 3, 6, 12, 24 months |
| Health-Related Quality of Life | Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12). | Baseline, 6 weeks, 3, 6, 12, 24 months |
| Hamilton |
| Ontario |
| L8L 2X2 |
| Canada |
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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