Efficacy of NSAID Peritendinous Injection for Acute Tendinitis

NCT06834425 | Active Not Recruiting DMC

• 2 other identifiers: N202412008114-wf-eva-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinitis; Acute Tendonitis; NSAID (Non-Steroidal Anti-Inflammatory Drug)

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale

  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 Outcomes (3)

• Disabilities of the Arm, Shoulder, and Hand (DASH)

  Baseline, 3-day, 7-day and 28-day after injection

• Foot and Ankle Disability Index (FADI)

  Baseline, 3-day, 7-day and 28-day after injection

• Pain pressure threshold

  Baseline, 3-day, 7-day and 28-day after injection

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: Peritendinous NSAID injection

Control group

PLACEBO COMPARATOR

Local anesthetics and normal saline peritendinous injection for acute tendinitis

Drug: Control group (placebo)

Interventions

Peritendinous NSAID injection DRUG

Peritendinous NSAID (parecoxib) injection

Also known as: NSAID injection

Intervention group

Control group (placebo) DRUG

Normal saline mixed with local anesthetics injection

Also known as: Sham injection

Control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ultrasonography diagnosed acute tendinitis with inflammation
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wan Fang Hospital, Taipei Medical University

Taipei, 116, Taiwan

Location

Related Publications (7)

• Rhim HC, Ruiz J, Taseh A, Afunugo W, Crockett Z, Schon J, Pan X, Shin J, Schowalter S, Jang KM, Robinson DM. Nonsteroidal Anti-Inflammatory Drug Injections versus Steroid Injections in the Management of Upper and Lower Extremity Orthopedic Conditions: A Systematic Review with Meta-Analysis. J Clin Med. 2024 Feb 17;13(4):1132. doi: 10.3390/jcm13041132.

  PMID: 38398445 RESULT

• Ziradkar R, Best TM, Quintero D, Paultre K. Nonsteroidal Anti-inflammatory and Corticosteroid Injections for Shoulder Impingement Syndrome: A Systematic Review and Meta-analysis. Sports Health. 2023 Jul-Aug;15(4):579-591. doi: 10.1177/19417381221108726. Epub 2022 Jul 27.

  PMID: 35897160 RESULT

• Sardana V, Burzynski J, Hasan K, Zalzal P. Are non-steroidal anti-inflammatory drug injections an alternative to steroid injections for musculoskeletal pain?: A systematic review. J Orthop. 2018 Aug 16;15(3):812-816. doi: 10.1016/j.jor.2018.08.022. eCollection 2018 Sep.

  PMID: 30140124 RESULT

• Kim YB, Lee WS, Won JS. The effects of a single-dose subacromial injection of a nonsteroidal anti-inflammatory drug in geriatric patients with subacromial impingement syndrome: a randomized double-blind study. Clin Shoulder Elb. 2021 Mar;24(1):4-8. doi: 10.5397/cise.2021.00052. Epub 2021 Mar 2.

  PMID: 33652505 RESULT

• Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.

  PMID: 27402605 RESULT

• Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22.

  PMID: 23177167 RESULT

• Shakeel H, Ahmad TS. Steroid injection versus NSAID injection for trigger finger: a comparative study of early outcomes. J Hand Surg Am. 2012 Jul;37(7):1319-23. doi: 10.1016/j.jhsa.2012.03.040.

  PMID: 22721455 RESULT

MeSH Terms

Conditions

Tendinopathy

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Control Groups; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yu-Hsuan Cheng, MD, MS

  Taipei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: February 10, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)