Efficacy of NSAID Peritendinous Injection for Acute Tendinitis

Not Applicable

Active, not recruiting

• Conditions: Tendinitis; Acute Tendonitis; NSAID (Non-Steroidal Anti-Inflammatory Drug)
• Interventions: Drug: Peritendinous NSAID injection; Drug: Control group (placebo)

• Registration Number: NCT06834425
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-10
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Peritendinous NSAID injection	Local anesthetics and NSAID(parecoxib) peritendinous Injection for acute tendinitis
Control group	Control group (placebo)	Local anesthetics and normal saline peritendinous injection for acute tendinitis

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	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.

Secondary Outcome Measures

Name	Time	Method
Foot and Ankle Disability Index (FADI)	Baseline, 3-day, 7-day and 28-day after injection	Foot and Ankle Disability Index (FADI) for lower limb functionality.
Disabilities of the Arm, Shoulder, and Hand (DASH)	Baseline, 3-day, 7-day and 28-day after injection	Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb functionality
Pain pressure threshold	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.

Trial Locations

Locations (1)

Wan Fang Hospital, Taipei Medical University; 🇨🇳 Taipei, Taiwan