Efficacy of NSAID Peritendinous Injection for Acute Tendinitis

February 18, 2025 updated by: Yu-Hsuan Cheng, Taipei Medical University WanFang Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Wan Fang Hospital, Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Local anesthetics and NSAID(parecoxib) peritendinous Injection for acute tendinitis
Drug: Peritendinous NSAID injection
Peritendinous NSAID (parecoxib) injection
Other Names:
  • NSAID injection
Placebo Comparator: Control group
Local anesthetics and normal saline peritendinous injection for acute tendinitis
Drug: Control group (placebo)
Normal saline mixed with local anesthetics injection
Other Names:
  • Sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
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.
Baseline, at 12 hours post-injection, and on each day from 1 to 7 days after the injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder, and Hand (DASH)
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
Baseline, 3-day, 7-day and 28-day after injection
Foot and Ankle Disability Index (FADI)
Time Frame: Baseline, 3-day, 7-day and 28-day after injection
Foot and Ankle Disability Index (FADI) for lower limb functionality.
Baseline, 3-day, 7-day and 28-day after injection
Pain pressure threshold
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.
Baseline, 3-day, 7-day and 28-day after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Chair: Yu-Hsuan Cheng, MD, MS, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202412008
  • 114-wf-eva-19 (Other Grant/Funding Number: Wan Fang Hospital, Taipei Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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