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| ID | Type | Description | Link |
|---|---|---|---|
| 114-wf-eva-19 | Other Grant/Funding Number | Wan Fang Hospital, Taipei Medical University |
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This study evaluates whether NSAID peritendinous or ligament injections at acute sprain sites can relieve pain and restore function.
Forty patients will be randomly assigned to either the injection or oral NSAID group. Pain will be assessed subjectively using the Numeric Pain Rating Scale and objectively through pressure pain threshold measurements. Functional outcomes (DASH for the upper limb, FADI for the lower limb) will be evaluated before treatment and at 3 days, 1 week, and 4 weeks post-treatment.
Acute tendon inflammation is a common sports injury, typically treated with oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) or local corticosteroid injections at the affected site. Direct corticosteroid injections provide the fastest relief; however, the World Anti-Doping Agency (WADA) has restricted the use of corticosteroids by any route in its latest banned substance list. As a result, corticosteroid injections into tendons or joints, which were previously allowed during competitions, can no longer be used. Currently, the only methods available for acute inflammation relief during competitions are oral NSAIDs and ice therapy. For athletes without structural damage who need to quickly reduce inflammation and return to play, these methods may be insufficient.
Previous clinical studies on NSAID injections into tendons and joints have shown that local NSAID injections are equally effective as corticosteroid injections for treating shoulder impingement syndrome and knee osteoarthritis. However, these studies mainly focused on patients with chronic arthritis and tendinitis. The difference in efficacy between oral NSAIDs and tendon injections during the acute phase of inflammation remains unknown. This study aims to compare different routes of NSAID administration to identify the most appropriate treatment for managing acute tendinitis in high-level athletes.
We hypothesize that peritendinous NSAID injections will provide greater pain relief and functional improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Local anesthetics and NSAID(parecoxib) peritendinous Injection for acute tendinitis |
|
| Control group | Placebo Comparator | Local anesthetics and normal saline peritendinous injection for acute tendinitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritendinous NSAID injection | Drug | Peritendinous NSAID (parecoxib) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale | The 11-point Numeric Rating Scale (NRS) is a subjective pain assessment tool that ranges from 0 to 10. A score of '0' indicates the complete absence of pain (e.g., "no pain"), while a score of '10' represents the most severe pain imaginable (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). This scale allows individuals to quantify their pain intensity, facilitating communication between patients and healthcare providers for better pain management. | Baseline, at 12 hours post-injection, and on each day from 1 to 7 days after the injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand (DASH) | Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb functionality | Baseline, 3-day, 7-day and 28-day after injection |
| Foot and Ankle Disability Index (FADI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Hsuan Cheng, MD, MS | Taipei Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wan Fang Hospital, Taipei Medical University | Taipei | 116 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38398445 | Result | Rhim HC, Ruiz J, Taseh A, Afunugo W, Crockett Z, Schon J, Pan X, Shin J, Schowalter S, Jang KM, Robinson DM. Nonsteroidal Anti-Inflammatory Drug Injections versus Steroid Injections in the Management of Upper and Lower Extremity Orthopedic Conditions: A Systematic Review with Meta-Analysis. J Clin Med. 2024 Feb 17;13(4):1132. doi: 10.3390/jcm13041132. | |
| 35897160 |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D035061 | Control Groups |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| Control group (placebo) | Drug | Normal saline mixed with local anesthetics injection |
|
|
Foot and Ankle Disability Index (FADI) for lower limb functionality.
| Baseline, 3-day, 7-day and 28-day after injection |
| Pain pressure threshold | A manometer was used to measure the pain pressure threshold at the most tender point of the affected area. | Baseline, 3-day, 7-day and 28-day after injection |
| Ziradkar R, Best TM, Quintero D, Paultre K. Nonsteroidal Anti-inflammatory and Corticosteroid Injections for Shoulder Impingement Syndrome: A Systematic Review and Meta-analysis. Sports Health. 2023 Jul-Aug;15(4):579-591. doi: 10.1177/19417381221108726. Epub 2022 Jul 27. |
| 30140124 | Result | Sardana V, Burzynski J, Hasan K, Zalzal P. Are non-steroidal anti-inflammatory drug injections an alternative to steroid injections for musculoskeletal pain?: A systematic review. J Orthop. 2018 Aug 16;15(3):812-816. doi: 10.1016/j.jor.2018.08.022. eCollection 2018 Sep. |
| 33652505 | Result | Kim YB, Lee WS, Won JS. The effects of a single-dose subacromial injection of a nonsteroidal anti-inflammatory drug in geriatric patients with subacromial impingement syndrome: a randomized double-blind study. Clin Shoulder Elb. 2021 Mar;24(1):4-8. doi: 10.5397/cise.2021.00052. Epub 2021 Mar 2. |
| 27402605 | Result | Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18. |
| 23177167 | Result | Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22. |
| 22721455 | Result | Shakeel H, Ahmad TS. Steroid injection versus NSAID injection for trigger finger: a comparative study of early outcomes. J Hand Surg Am. 2012 Jul;37(7):1319-23. doi: 10.1016/j.jhsa.2012.03.040. |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |