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

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What is this study about?

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.

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.

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)

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zbigniew Zegota Specjalistyczny Osrodek Leczniczo – Badawczy Ostróda Poland

Other Sites

Site Name City Country Status
Santa Sp. z o.o. Lodz Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Silmedic Sp. z o.o. Katowice Poland
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Cbccapq Mymtxvhb Lpzrscb Jpqeoz Łbqt Chojnice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
15.04.2024

Trial locations

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.

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.

Trial ID:
2024-510839-22-00
Protocol code:
300128
Trial Phase:
Human Pharmacology (Phase I) – Other

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