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TendinitisNCT06834425

Efficacy of NSAID Peritendinous Injection for Acute Tendinitis

A study testing Peritendinous NSAID injection in people with Tendinitis and Acute Tendonitis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
What is being tested?
Peritendinous NSAID injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTaiwan
Study dates
10 Feb 2025to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Wan Fang Hospital, Taipei Medical University

    Taipei, 116

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Peritendinous NSAID injection, Control group (placebo)
Medical subject headings
Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peritendinous NSAID injectionDrug

    Also called NSAID injection

    Peritendinous NSAID (parecoxib) injection

  • Control group (placebo)Drug

    Also called Sham injection

    Normal saline mixed with local anesthetics injection

Study groups in NCT06834425
Study groupRoleWhat they receive
Intervention groupExperimentalLocal anesthetics and NSAID(parecoxib) peritendinous Injection for acute tendinitis
Receives: Drug: Peritendinous NSAID injection
Control groupPlacebo comparatorLocal anesthetics and normal saline peritendinous injection for acute tendinitis
Receives: Drug: Control group (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, at 12 hours post-injection, and on each day from 1 to 7 days after the injection.

Secondary outcomes (3)

  1. Disabilities of the Arm, Shoulder, and Hand (DASH)

    Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb functionality

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

  2. Foot and Ankle Disability Index (FADI)

    Foot and Ankle Disability Index (FADI) for lower limb functionality.

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

  3. Pain pressure threshold

    A manometer was used to measure the pain pressure threshold at the most tender point of the affected area.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start10 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06834425
Sponsor's protocol ID
N202412008
Other IDs
114-wf-eva-19
Status last verified
Feb 2025
First submitted
13 Feb 2025
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38398445

  • 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.

    PubMed 35897160

  • 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.

    PubMed 30140124

  • 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.

    PubMed 33652505

  • 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.

    PubMed 27402605

  • 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.

    PubMed 23177167

  • 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.

    PubMed 22721455

Questions about this trial

What is this clinical trial studying?

A study testing Peritendinous NSAID injection in people with Tendinitis and Acute Tendonitis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (time frame: Baseline, at 12 hours post-injection, and on each day from 1 to 7 days after the injection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834425, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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