Efficacy of NSAID Peritendinous Injection for Acute Tendinitis

NCT ID: NCT06834425

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2026-03-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Peritendinous NSAID injection

Intervention Type DRUG

Peritendinous NSAID (parecoxib) injection

Control group

Local anesthetics and normal saline peritendinous injection for acute tendinitis

Group Type PLACEBO_COMPARATOR

Control group (placebo)

Intervention Type DRUG

Normal saline mixed with local anesthetics injection

Interventions

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Peritendinous NSAID injection

Peritendinous NSAID (parecoxib) injection

Intervention Type DRUG

Control group (placebo)

Normal saline mixed with local anesthetics injection

Intervention Type DRUG

Other Intervention Names

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NSAID injection Sham injection

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Hsuan Cheng

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Hsuan Cheng, MD, MS

Role: STUDY_CHAIR

Taipei Medical University

Locations

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Wan Fang Hospital, Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 38398445 (View on PubMed)

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.

Reference Type RESULT
PMID: 35897160 (View on PubMed)

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.

Reference Type RESULT
PMID: 30140124 (View on PubMed)

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.

Reference Type RESULT
PMID: 33652505 (View on PubMed)

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.

Reference Type RESULT
PMID: 27402605 (View on PubMed)

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.

Reference Type RESULT
PMID: 23177167 (View on PubMed)

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.

Reference Type RESULT
PMID: 22721455 (View on PubMed)

Other Identifiers

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114-wf-eva-19

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N202412008

Identifier Type: -

Identifier Source: org_study_id

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