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Knee pain relief: study tests if ibuprofen ruins injection benefits

NCT ID NCT06911359

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether taking ibuprofen (a common painkiller) along with dextrose prolotherapy injections affects pain and function in people with knee osteoarthritis. Researchers will give 68 adults either ibuprofen or a placebo for 7 days after each of three injections. They will measure pain and knee function using questionnaires over 12 weeks to see if the ibuprofen changes how well the injections work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dextrose prolotherapy injection and oral ibuprofen
What this could lead to
If it works, this could show that taking ibuprofen along with dextrose prolotherapy is safe and does not reduce the injection's pain-relieving effects for knee osteoarthritis.
What could go wrong
This is a small, early-phase trial with only 68 participants, so results may not apply to everyone. It is testing a common combination, not a new breakthrough, and the primary goal is to see if ibuprofen interferes with the injection, not to cure the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be DoD Healthcare beneficiaries empaneled at DGMC * Adults aged 45-75 years with a clinical diagnosis of Knee OA (either unilateral or bilateral) based on clinical and radiographic criteria as defined by the American College of Rheumatology (Altman 1987) * Knee radiographs (within 2 years of start date) with Kellgren-Lawrence classification of 2-3 * Moderate to severe Knee pain for at least 3 months defined as a score of ≥4 using the NPRS (0-10) in response to the question "What is the average level of your left/ right knee pain in the past 3 months?" * English speaking * Not pregnant * Not breastfeeding * No allergy to dextrose, lidocaine, or sulfite Exclusion Criteria: * Previous knee replacement surgery * Previous meniscus repair/debridement surgery or chondral replacement surgery * Any intra-articular injection including steroid, prolotherapy or platelet rich plasms within the previous 3 months * Significant effusion as defined by a ballotable patella * Pregnancy or breastfeeding * Current/ongoing medical problems obtained from chart review contraindicating NSAID use to include chronic kidney disease stage II or higher, acute interstitial nephritis, coronary artery disease requiring percutaneous coronary intervention (PCI) or bypass surgery; Major Adverse Coronary Event (MACE), body mass index (BMI) ≥40, inflammatory arthropathy (gouty arthritis, psoriatic arthritis, or septic arthritis), history of GI bleed. * Non-English speaking * Allergy to dextrose, lidocaine, or sulfite

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • David Grant USAF Medical Center

    RECRUITING

    Travis AFB, California, 94535, United States

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