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临床试验/NCT06834425
NCT06834425进行中(未招募)不适用

Efficacy of NSAID Peritendinous Injection for Acute Tendinitis

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Intervention group

Experimental

Local anesthetics and NSAID(parecoxib) peritendinous Injection for acute tendinitis

干预措施: Peritendinous NSAID injection (Drug)

Control group

Placebo Comparator

Local anesthetics and normal saline peritendinous injection for acute tendinitis

干预措施: Control group (placebo) (Drug)

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: 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.

次要结局

  • Foot and Ankle Disability Index (FADI)(Baseline, 3-day, 7-day and 28-day after injection)
  • Disabilities of the Arm, Shoulder, and Hand (DASH)(Baseline, 3-day, 7-day and 28-day after injection)
  • Pain pressure threshold(Baseline, 3-day, 7-day and 28-day after injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Hsuan Cheng

Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity

Taipei Medical University WanFang Hospital

研究点 (1)

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