Wan Fang Hospital, Taipei Medical University
Taipei, 116, Taiwan
NCT Number: NCT06834425
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.
This study is active but is not currently recruiting participants.
20 year–70 year
All sexes
Interventional
Not applicable
Taipei, 116, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Peritendinous NSAID (parecoxib) injection
Other names: NSAID injection
Normal saline mixed with local anesthetics injection
Other names: Sham injection
Time frame: Baseline, at 12 hours post-injection, and on each day from 1 to 7 days after the injection.
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.
Time frame: Baseline, 3-day, 7-day and 28-day after injection
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb functionality
Time frame: Baseline, 3-day, 7-day and 28-day after injection
Foot and Ankle Disability Index (FADI) for lower limb functionality.
Time frame: Baseline, 3-day, 7-day and 28-day after injection
A manometer was used to measure the pain pressure threshold at the most tender point of the affected area.
Taipei Medical University WanFang Hospital
Other
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