Knee Osteoarthritis (OA)Phase 2NCT06911359
The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis
A Phase 2 study testing Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times. in people with Knee Osteoarthritis (OA), run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
Our purpose is to expand upon the results of the pilot study performed at David Grant Medical Center (DGMC) which showed that concomitant non-steroidal NSAID use in adults with knee osteoarthritis (OA) undergoing a three-shot dextrose prolotherapy (DPT) injection series did not negate the efficacy of DPT. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 31 Dec 2026
- Phase
- Phase 2
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlton J Covey, MD contact
United States1 site, 1 recruiting
- Recruiting
David Grant USAF Medical Center
Travis AFB, California, 94535
Alexander R Kim, MD, 707-423-3057, Alexander.r.kim.mil@health.mil
About this study
Official title: The Effect of Non-steroidal Anti-inflammatory Drug (NSAID) Use on the Efficacy of Dextrose Prolotherapy in the Treatment of Knee Osteoarthritis: A Randomized Controlled Trial
Our purpose is to expand upon the results of the pilot study performed at David Grant Medical Center (DGMC) which showed that concomitant non-steroidal NSAID use in adults with knee osteoarthritis (OA) undergoing a three-shot dextrose prolotherapy (DPT) injection series did not negate the efficacy of DPT. Additionally, it showed that giving both treatments simultaneously is safe and efficacious. The small sample size and design of the pilot study limited the conclusions that can be drawn on the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) during DPT treatment.
This is a double-blinded, randomized, controlled trial that includes a subject population of males and females between the ages of 45-75 years who are DoD beneficiaries empaneled at DGMC with a history of chronic, symptomatic knee osteoarthritis in one or both knees, that meet study criteria.
Read more
Participants will have study inclusion/exclusion and knee films (within the past 2 years) reviewed by a study investigator to confirm eligibility to participate in the study. Eligible participants will be consented then randomized into treatment groups (ibuprofen, placebo) by the pharmacy. Participants will provide a baseline assessment of pain and dysfunction using the Numeric Pain Rating Scale (NPRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Participants will then have a series of three injections of 4mL of 25% dextrose mixed with 1% lidocaine into the knee under ultrasound guidance, performed at 0, 4 and 8 weeks (+/- 1 week) in addition to a 7-day supply of the study drug (ibuprofen, placebo) at these time points. NPRS and KOOS scores will be collected at 0, 4, 8 and 12 weeks. During the study period, participants will be counseled to avoid oral analgesics (other than what has been prescribed for them as part of the study) including NSAIDs, acetaminophen, or opioids, in addition to other procedures to treat their knee pain to include other injections, acupuncture, physical therapy, and surgery.
The primary outcome is to determine the effect of concomitant oral ibuprofen vs. placebo use on intra-articular knee injections using hypertonic dextrose and the determine the short and long-term outcomes in each treatment group (ibuprofen, placebo) using the NPRS and KOOS questionnaires to assess pain and function.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times., Participants are given a placebo to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.Drug
The other group is given a placebo when they receive their dextrose prolotherapy (DPT) injection
Participants are given a placebo to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.Drug
The other group is given Ibuprofen when they receive their dextrose prolotherapy (DPT) injection
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen group | Active comparator | Not described Receives: Drug: Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times. |
| Placebo group | Placebo comparator | Not described Receives: Drug: Participants are given a placebo to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury in Osteoarthritis (KOOS) questionnaire scores
The KOOS questionnaire consist of a total of 23 items divided (unequally) among 5 subscales. The subscales include pain (5 items), symptoms (4 items), activities of daily living (ADL) (9 items), sport/recreation (3 items), and quality of life (QoL) (2 items). Each item is scored on a scale of 0-4. Zero is assigned to "never", "none," and "not at all" responses. Four is assigned to "always", "extreme," "totally," and "constantly" responses. Calculate mean scores for each subscale by adding the scores for each item (in the subscale) then dividing it by the total number of items (in the subscale). Then multiply the calculated mean scores (for each subscale) by 100, divide it by 4, then subtract it from 100. Total subscale scores range from 0 -100. 0 indicates extreme problems and 100 indicates no problems.
Measured: From enrollment to the end of treatment at 12 weeks
Change in Numeric Pain Rating Scale (NPRS) scores
The NPRS is a 1-item questionnaire assessing pain severity using a number which describes the level of knee pain over the last 24 hours. Participants are to put an "X" on a linear scale from 0-10. Zero (0) is no pain and 10 is the worst possible pain.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start31 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alexander R Kim, MD, Principal investigator, David Grant USAF Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911359
- Sponsor's protocol ID
- FDG20230042H
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-steroidal Anti-inflammatory Drug (NSAID) Use on the Efficacy of Dextrose Prolotherapy in the Treatment of Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06911359
- Acronym / sponsor ID
- FDG20230042H
- Conditions
- Knee Osteoarthritis (OA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our purpose is to expand upon the results of the pilot study performed at David Grant Medical Center (DGMC) which showed that concomitant non-steroidal NSAID use in adults with knee osteoarthritis (OA) undergoing a three-shot dextrose prolotherapy (DPT) injection series did not negate the efficacy of DPT. Additionally, it showed that giving both treatments simultaneously is safe and efficacious. The small sample size and design of the pilot study limited the conclusions that can be drawn on the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) during DPT treatment.
This is a double-blinded, randomized, controlled trial that includes a subject population of males and females between the ages of 45-75 years who are DoD beneficiaries empaneled at DGMC with a history of chronic, symptomatic knee osteoarthritis in one or both knees, that meet study criteria.
Participants will have study inclusion/exclusion and knee films (within the past 2 years) reviewed by a study investigator to confirm eligibility to participate in the study. Eligible participants will be consented then randomized into treatment groups (ibuprofen, placebo) by the pharmacy. Participants will provide a baseline assessment of pain and dysfunction using the Numeric Pain Rating Scale (NPRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Participants will then have a series of three injections of 4mL of 25% dextrose mixed with 1% lidocaine into the knee under ultrasound guidance, performed at 0, 4 and 8 weeks (+/- 1 week) in addition to a 7-day supply of the study drug (ibuprofen, placebo) at these time points. NPRS and KOOS scores will be collected at 0, 4, 8 and 12 weeks. During the study period, participants will be counseled to avoid oral analgesics (other than what has been prescribed for them as part of the study) including NSAIDs, acetaminophen, or opioids, in addition to other procedures to treat their knee pain to include other injections, acupuncture, physical therapy, and surgery.
The primary outcome is to determine the effect of concomitant oral ibuprofen vs. placebo use on intra-articular knee injections using hypertonic dextrose and the determine the short and long-term outcomes in each treatment group (ibuprofen, placebo) using the NPRS and KOOS questionnaires to assess pain and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen group | Active comparator | Drug: Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times. |
| Placebo group | Placebo comparator | Drug: Participants are given a placebo to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.The other group is given a placebo when they receive their dextrose prolotherapy (DPT) injection | Drug | Ibuprofen group |
| Participants are given a placebo to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.The other group is given Ibuprofen when they receive their dextrose prolotherapy (DPT) injection | Drug | Placebo group |
Primary outcome
Change in Knee Injury in Osteoarthritis (KOOS) questionnaire scores
Time frame: From enrollment to the end of treatment at 12 weeks
The KOOS questionnaire consist of a total of 23 items divided (unequally) among 5 subscales. The subscales include pain (5 items), symptoms (4 items), activities of daily living (ADL) (9 items), sport/recreation (3 items), and quality of life (QoL) (2 items). Each item is scored on a scale of 0-4. Zero is assigned to "never", "none," and "not at all" responses. Four is assigned to "always", "extreme," "totally," and "constantly" responses. Calculate mean scores for each subscale by adding the scores for each item (in the subscale) then dividing it by the total number of items (in the subscale). Then multiply the calculated mean scores (for each subscale) by 100, divide it by 4, then subtract it from 100. Total subscale scores range from 0 -100. 0 indicates extreme problems and 100 indicates no problems.
Change in Numeric Pain Rating Scale (NPRS) scores
Time frame: From enrollment to the end of treatment at 12 weeks
The NPRS is a 1-item questionnaire assessing pain severity using a number which describes the level of knee pain over the last 24 hours. Participants are to put an "X" on a linear scale from 0-10. Zero (0) is no pain and 10 is the worst possible pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlton J Covey, MD contact
Alexander R Kim, MD principal investigator
David Grant USAF Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times. in people with Knee Osteoarthritis (OA), run by David Grant U.S. Air Force Medical Center at 1 site in United States.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Nov 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Alexander R Kim, MD (707-423-3057, Alexander.r.kim.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury in Osteoarthritis (KOOS) questionnaire scores (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.