Clinical trial NCT06834425: Efficacy of NSAID Peritendinous Injection for Acute Tendinitis
Official title: Efficacy of NSAID Peritendinous Injection for Acute Tendinitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tendinitis
Acute Tendonitis
NSAID (Non-Steroidal Anti-Inflammatory Drug)
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ultrasonography diagnosed acute tendinitis with inflammation
* 20-70 years old

Exclusion Criteria:

* Cognitive impairment.
* Post operation at painful site.
* Neuropathic pain or vascularity disease
* Unable to receive injection therapy, including a history of syncope during injection.
* Allergy history to NSAID
* Within 14 days after coronary artery bypass graft, CABG

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline, at 12 hours post-injection, and on each day from 1 to 7 days after the injection.
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: Baseline, 3-day, 7-day and 28-day after injection
measure: Foot and Ankle Disability Index (FADI)
timeFrame: Baseline, 3-day, 7-day and 28-day after injection
measure: Pain pressure threshold
timeFrame: Baseline, 3-day, 7-day and 28-day after injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan Fang Hospital, Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Yu-Hsuan Cheng, MD, MS
role: STUDY_CHAIR
References:
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