Not recruiting

Effects of Diclofenac Diethylamine Gel on Physical Activity and Quality of Life in Patients with Mild Knee Osteoarthritis

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on knee osteoarthritis, a condition that causes joint pain and stiffness in the knee. The research examines two medications: Voltaren SPORT gel and Voltaren MAX gel, which both contain diclofenac diethylamine as the active ingredient. These gels are applied directly to the skin over the painful knee area to reduce pain and inflammation.

The purpose of this research is to understand how these medications affect physical activity and quality of life in people with mild knee osteoarthritis. The study will monitor daily activities like walking, climbing stairs, and movement patterns using a special activity tracking device that participants will wear.

During the study, participants will use the gel for up to three weeks. Throughout this period, the tracking device will measure various aspects of movement, including how much time is spent being active versus inactive, walking speed, and morning stiffness. The gel is applied to the skin of the affected knee area, and participants' physical activity levels will be monitored to see how the treatment affects their ability to move and perform daily activities.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial phase
The study begins with evaluating your knee pain using a visual pain scale.
You will receive a physical activity tracker that needs to be worn throughout the study period.
Initial measurements of your physical activity will be recorded to establish a baseline.
Step 2
Treatment period - Week 1
You will start using Voltaren Gel on your knee.
The gel should be applied directly to the affected knee area.
The activity tracker will monitor your daily physical activities, including:
- Number of steps taken
- Stairs climbed and descended
- Movement speed
- Active versus inactive time periods
- Morning mobility (30 and 60 minutes after waking)
Step 3
Treatment period - Week 2
Continue applying Voltaren Gel as directed.
The activity tracker will continue monitoring all physical activities.
Your movement patterns and activity levels will be recorded and compared to the first week.
Step 4
Final week - Week 3
Continue the gel application through the final week.
The activity tracker will record the final set of measurements.
All physical activity data will be collected to evaluate changes in your mobility over the three-week period.
Step 5
Study completion
The study concludes after 21 days of gel use.
Return the activity tracker device.
Your participation in the study will be complete.

Who can join the trial?

5 criteria

Must be between 40 and 85 years old
Must have been diagnosed with mild knee osteoarthritis, confirmed by an X-ray or other imaging test taken within the last 3 years
Must experience knee pain that rates between 40 and 70 millimeters on the pain scale during the initial screening visit (where 0 means no pain and 100 means worst possible pain)
Must be willing to apply Voltaren Gel (a topical pain relief medication) for a period of up to 3 weeks
Can be either male or female

Who cannot join the trial?

15 criteria

Severe or serious knee osteoarthritis (beyond mild cases)
Age below 18 or above 65 years
Pregnancy or breastfeeding
Known allergy or sensitivity to diclofenac (the active ingredient in Voltaren Gel) or similar pain medications
Open wounds, cuts, or infections in the knee area
Recent knee surgery (within the last 6 months)
Current participation in other clinical trials
Inability to use or access a digital activity tracker
Serious heart conditions or high blood pressure
History of stomach ulcers or bleeding disorders
Severe kidney or liver problems
Regular use of blood thinning medications
Inability to follow study procedures or attend required visits
Mental conditions that could interfere with study participation
Active joint infections or other serious infections

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Medyczne LukaMed Joanna Łuka
Verified
Chojnice, Poland
Santa Sp. z o.o.
Verified
Lodz, Poland
Zbigniew Zegota Specjalistyczny Osrodek Leczniczo - Badawczy
Verified
Ostróda, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Voltaren Gel is a topical pain relief medication that contains diclofenac. It is applied directly to the skin to reduce pain and inflammation in muscles, joints, and soft tissues. This non-steroidal anti-inflammatory medication (NSAID) works by reducing substances in the body that cause pain and inflammation. It is commonly used for conditions such as arthritis pain, muscle aches, sprains, and strains. The gel format allows the medication to be absorbed through the skin and work directly in the area where it is applied, rather than going through the entire body like oral medications.

Diclofenac Diethylamine

What is already known about the treatment

Voltaren Gel – A topical non-steroidal anti-inflammatory drug (NSAID) that is applied directly to the skin over painful arthritic joints, particularly effective for knee osteoarthritis. The active ingredient, diclofenac, works by reducing substances in the body that cause pain and inflammation. This medication has been well-established in medical literature as an effective treatment for osteoarthritis symptoms, offering a safer alternative to oral NSAIDs due to lower systemic absorption. The gel formulation allows for targeted relief while minimizing the risk of gastrointestinal side effects commonly associated with oral NSAID medications.

Investigated diseases

Osteoarthritis of the knee - A degenerative joint disease affecting the knee, characterized by the gradual breakdown of cartilage that cushions the bones. The condition causes the joint surfaces to become rougher over time, leading to friction between bones. Patients typically experience stiffness, particularly in the morning or after periods of inactivity, along with reduced mobility in the affected knee. The condition can cause varying levels of discomfort during physical activities and may affect how easily a person can walk, climb stairs, or perform other daily activities. The progression is usually gradual, with symptoms developing and changing over months or years.