Knee OsteoarthritisPhase 2NCT07308470
Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis
A Phase 2 study testing Etodolac-Loaded Solid Lipid Nanoparticle Gel in people with Knee Osteoarthritis, run by Pharos University in Alexandria at 1 site in Egypt.
Trial summary
Brief Summary: Knee osteoarthritis (OA) is a common, disabling condition affecting the weight-bearing knee joint, leading to pain, reduced function, and muscle weakness, particularly of the quadriceps. Strengthening exercises are recommended to improve joint stability, physical function, and slow disease progression. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Etodolac-Loaded Solid Lipid Nanoparticle Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2026to 7 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 45 and 60 years.
- Mild to moderate unilateral knee osteoarthritis (Kellgren-Lawrence grades II-III).
- Ability to walk independently without assistive devices.
- Body Mass Index (BMI) < 30 kg/m².
- No participation in resistance training in the 3 months prior to enrollment.
- Referred by an orthopedic surgeon and diagnosed based on clinical and radiological examination.
Who cannot join
- Severe or bilateral knee osteoarthritis (Kellgren-Lawrence grade IV).
- Congenital or acquired inflammatory, rheumatic, or neurological disorders affecting the knee.
- Repeated treatment with steroids or secondary knee OA.
- History of joint replacement surgery in the knee or hip.
- Cardiovascular or neuromuscular disorders.
- Diabetes mellitus.
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria
Brief Summary:
Knee osteoarthritis (OA) is a common, disabling condition affecting the weight-bearing knee joint, leading to pain, reduced function, and muscle weakness, particularly of the quadriceps. Strengthening exercises are recommended to improve joint stability, physical function, and slow disease progression. Etodolac, a selective NSAID approved for osteoarthritis, has proven analgesic and anti-inflammatory effects. This study investigates the adjunctive effect of a topical Etodolac-loaded solid lipid nanoparticle gel combined with traditional physiotherapy in patients with knee OA. Thirty patients with mild to moderate unilateral tibiofemoral OA will be randomized into two groups: traditional physiotherapy alone or physiotherapy plus Etodolac gel. Outcomes including pain, knee function, functional performance, quadriceps strength, and proprioception will be assessed at baseline and after four weeks. The study aims to determine whether adding topical Etodolac enhances the benefits of standard physiotherapy in managing knee OA.
Read the detailed description
This randomized clinical trial investigates the effect of adding a topical Etodolac-loaded solid lipid nanoparticle gel to traditional physiotherapy in patients with mild to moderate unilateral knee osteoarthritis (OA). Thirty patients aged 45-60 years will be randomly assigned to either physiotherapy alone (control) or physiotherapy plus Etodolac nanogel (experimental) for 4 weeks. Outcomes include pain (VAS), knee function (WOMAC), functional performance (TUG, 2MWT), quadriceps strength, and proprioception. The study aims to determine whether the combination therapy provides superior pain relief, improved joint function, and enhanced muscle performance compared with physiotherapy alone, while potentially reducing systemic NSAID exposure
- Conditions
- Knee Osteoarthritis
- Being tested
- Etodolac-Loaded Solid Lipid Nanoparticle Gel
- Keywords
- osteoarthritis-Etodolac
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etodolac-Loaded Solid Lipid Nanoparticle GelCombination product
Also called Traditional Aerobic Training
Physiotherapy program includes:
Quadriceps strengthening exercises
Lower limb muscle conditioning
Aerobic walking program
Functional mobility exercises
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel | Experimental | Participants will receive the same structured physiotherapy program as the control group, in addition to topical application of Etodolac-loaded solid lipid nanoparticle gel on the affected knee.
Physiotherapy components:
Quadriceps strengthening exercises
Lower limb muscle conditioning
Aerobic walking program
Functional mobility exercises
Etodolac nanogel application: Applied topically according to the study protocol to provide localized analgesic and anti-inflammatory effects.
Duration: 4 weeks, with standardized physiotherapy sessions and daily topical gel application.
Purpose: To evaluate whether adding Etodolac-loaded nanoparticle gel enhances pain relief, knee function, functional performance, quadriceps strength, and proprioception compared with physiotherapy alone Receives: Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel |
| Traditional Physiotherapy Exercises | Active comparator | Participants will receive a structured physiotherapy program for knee osteoarthritis, which includes:
Quadriceps strengthening exercises
Lower limb muscle conditioning
Aerobic walking program
Functional mobility exercises
Duration: 4 weeks, following standardized procedures for all participants. Purpose: To serve as the control group for comparison with the experimental group receiving additional Etodolac-loaded nanoparticle gel Receives: Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Pain severity in patients with knee osteoarthritis measured using the Visual Analog Scale (VAS)Units on a 0-10 scale
Measured: Baseline, 4 weeks, 8 week
Secondary outcomes (3)
Functional Improvement
Improvement in knee function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale-Units on a 0-68 scale
Measured: Baseline, 4 weeks, 8 weeks
Patient Global Assessment of Disease Activity
Patient's overall assessment of their osteoarthritis symptoms measured using a 0-100 scaleوUnits on a 0-100 scale
Measured: Baseline, 4 weeks, 8 weeks
Physician's Global Assessmen
Physician's assessment of the patient's overall osteoarthritis status using a standardized scale-Units on a 0-100 scale
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start8 Jan 2026 (estimated)
- Primary completion7 Feb 2026 (estimated)
- Study completion7 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- This is a randomized, parallel-assignment, single-blind interventional study. Thirty patients with mild to moderate unilateral knee osteoarthritis will be randomly assigned to either a control group receiving traditional physiotherapy or an experimental group receiving physiotherapy plus topical Etodolac-loaded nanoparticle gel. Outcome measures will be assessed at baseline and after 4 weeks to evaluate pain, knee function, functional performance, quadriceps strength, and proprioception
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308470
- Sponsor's protocol ID
- PUA-PT-ETO-KOA-2025
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Reason: Data contains sensitive patient information and will be used only for the purposes of this study under confidentiality agreements. Access: Data may be available upon reasonable request to the principal investigator for approved research purposes, following ethical and institutional approvals
Publications
Trojian, T. H., Concoff, A. L., Joy, S. M., Hatzenbuehler, J. R., Saulsberry, W. J., & Coleman, C. I. (2016). AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes. British journal of sports medicine, 50(2), 84-92. 2 Murphy, L., Schwartz, T. A., Helmick, C. G., Renner, J. B., Tudor, G., Koch, G., ... & Jordan, J. M. (2008). Lifetime risk of symptomatic knee osteoarthritis. Arthritis Care & Research, 59(9), 1207-1213. 3 Altman, R., Lim, S., Steen, R. G., & Dasa, V. (2015). Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large US Health Claims Database. PloS one, 10(12). 4 Jegu AG, Pereira B, Andant N, and Coudeyre E. (2014). Effect of eccentric isokinetic strengthening in the rehabilitation of patients with knee osteoarthritis: Isogo, a randomized trial. Trials; 15(1): 106. 5 Segal, N. A., Williams, G. N., Davis, M. C., Wallace, R. B., & Mikesky, A. E. (2015). Efficacy of Blood Flow-Restricted, Low-Load Resistance Training in Women with Risk Factors for Symptomatic Knee Osteoarthritis. PM&R, 7(4), 376-384
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria
- ClinicalTrials.gov ID
- NCT07308470
- Acronym / sponsor ID
- PUA-PT-ETO-KOA-2025
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis-Etodolac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 8 Jan 2026 (estimated)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 7 Mar 2026 (estimated)
- First posted
- 29 Dec 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.
Brief Summary:
Knee osteoarthritis (OA) is a common, disabling condition affecting the weight-bearing knee joint, leading to pain, reduced function, and muscle weakness, particularly of the quadriceps. Strengthening exercises are recommended to improve joint stability, physical function, and slow disease progression. Etodolac, a selective NSAID approved for osteoarthritis, has proven analgesic and anti-inflammatory effects. This study investigates the adjunctive effect of a topical Etodolac-loaded solid lipid nanoparticle gel combined with traditional physiotherapy in patients with knee OA. Thirty patients with mild to moderate unilateral tibiofemoral OA will be randomized into two groups: traditional physiotherapy alone or physiotherapy plus Etodolac gel. Outcomes including pain, knee function, functional performance, quadriceps strength, and proprioception will be assessed at baseline and after four weeks. The study aims to determine whether adding topical Etodolac enhances the benefits of standard physiotherapy in managing knee OA.
Detailed description
This randomized clinical trial investigates the effect of adding a topical Etodolac-loaded solid lipid nanoparticle gel to traditional physiotherapy in patients with mild to moderate unilateral knee osteoarthritis (OA). Thirty patients aged 45-60 years will be randomly assigned to either physiotherapy alone (control) or physiotherapy plus Etodolac nanogel (experimental) for 4 weeks. Outcomes include pain (VAS), knee function (WOMAC), functional performance (TUG, 2MWT), quadriceps strength, and proprioception. The study aims to determine whether the combination therapy provides superior pain relief, improved joint function, and enhanced muscle performance compared with physiotherapy alone, while potentially reducing systemic NSAID exposure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-assignment, single-blind interventional study. Thirty patients with mild to moderate unilateral knee osteoarthritis will be randomly assigned to either a control group receiving traditional physiotherapy or an experimental group receiving physiotherapy plus topical Etodolac-loaded nanoparticle gel. Outcome measures will be assessed at baseline and after 4 weeks to evaluate pain, knee function, functional performance, quadriceps strength, and proprioception
| Arm | Type | Receives |
|---|---|---|
| Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel | Experimental | Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle GelParticipants will receive the same structured physiotherapy program as the control group, in addition to topical application of Etodolac-loaded solid lipid nanoparticle gel on the affected knee. Physiotherapy components: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises Etodolac nanogel application: Applied topically according to the study protocol to provide localized analgesic and anti-inflammatory effects. Duration: 4 weeks, with standardized physiotherapy sessions and daily topical gel application. Purpose: To evaluate whether adding Etodolac-loaded nanoparticle gel enhances pain relief, knee function, functional performance, quadriceps strength, and proprioception compared with physiotherapy alone |
| Traditional Physiotherapy Exercises | Active comparator | Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle GelParticipants will receive a structured physiotherapy program for knee osteoarthritis, which includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises Duration: 4 weeks, following standardized procedures for all participants. Purpose: To serve as the control group for comparison with the experimental group receiving additional Etodolac-loaded nanoparticle gel |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 45 and 60 years.
- Mild to moderate unilateral knee osteoarthritis (Kellgren-Lawrence grades II-III).
- Ability to walk independently without assistive devices.
- Body Mass Index (BMI) < 30 kg/m².
- No participation in resistance training in the 3 months prior to enrollment.
Key exclusion criteria (7 listed)
- Severe or bilateral knee osteoarthritis (Kellgren-Lawrence grade IV).
- Congenital or acquired inflammatory, rheumatic, or neurological disorders affecting the knee.
- Repeated treatment with steroids or secondary knee OA.
- History of joint replacement surgery in the knee or hip.
- Cardiovascular or neuromuscular disorders.
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 |
|---|---|---|
| Etodolac-Loaded Solid Lipid Nanoparticle GelAlso: Traditional Aerobic TrainingPhysiotherapy program includes: Quadriceps strengthening exercises Lower limb muscle conditioning Aerobic walking program Functional mobility exercises | Combination product | Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel, Traditional Physiotherapy Exercises |
Primary outcome
Pain Severity
Time frame: Baseline, 4 weeks, 8 week
Pain severity in patients with knee osteoarthritis measured using the Visual Analog Scale (VAS)Units on a 0-10 scale
3 secondary outcomes
Functional Improvement
Time frame: Baseline, 4 weeks, 8 weeks
Patient Global Assessment of Disease Activity
Time frame: Baseline, 4 weeks, 8 weeks
Physician's Global Assessmen
Time frame: Baseline, 4 weeks, 8 weeks
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 29 Dec 2025.
- BackgroundTrojian, T. H., Concoff, A. L., Joy, S. M., Hatzenbuehler, J. R., Saulsberry, W. J., & Coleman, C. I. (2016). AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes. British journal of sports medicine, 50(2), 84-92. 2 Murphy, L., Schwartz, T. A., Helmick, C. G., Renner, J. B., Tudor, G., Koch, G., ... & Jordan, J. M. (2008). Lifetime risk of symptomatic knee osteoarthritis. Arthritis Care & Research, 59(9), 1207-1213. 3 Altman, R., Lim, S., Steen, R. G., & Dasa, V. (2015). Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large US Health Claims Database. PloS one, 10(12). 4 Jegu AG, Pereira B, Andant N, and Coudeyre E. (2014). Effect of eccentric isokinetic strengthening in the rehabilitation of patients with knee osteoarthritis: Isogo, a randomized trial. Trials; 15(1): 106. 5 Segal, N. A., Williams, G. N., Davis, M. C., Wallace, R. B., & Mikesky, A. E. (2015). Efficacy of Blood Flow-Restricted, Low-Load Resistance Training in Women with Risk Factors for Symptomatic Knee Osteoarthritis. PM&R, 7(4), 376-384
- Individual participant dataSharing planned: No. Reason: Data contains sensitive patient information and will be used only for the purposes of this study under confidentiality agreements. Access: Data may be available upon reasonable request to the principal investigator for approved research purposes, following ethical and institutional approvals
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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.
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 Etodolac-Loaded Solid Lipid Nanoparticle Gel in people with Knee Osteoarthritis, run by Pharos University in Alexandria at 1 site in Egypt.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Dec 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 Egypt. 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. 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 Yosra Elnagar, proffesor (01277629944, yosra.elnaggar@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: Baseline, 4 weeks, 8 week). 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 NCT07308470, which also lists 1 linked publication.
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 29 Dec 2025.