FREEDOM-1 STUDY

Written By Hemant Kalia

Freedom-1 Study: New Treatment for Chronic Knee Pain

What is this study about?

The Freedom-1 Study is testing a wireless device that might help people with chronic knee pain from arthritis. This device sends gentle electrical signals to nerves near your knee to help reduce pain. Think of it like a tiny pacemaker for pain relief that goes under your skin.

Who can join this study?

Are you over 18 and have been suffering from chronic knee pain for at least three months? If so, you may be eligible to participate in the Freedom-1 Study. This research study is evaluating a new, non-drug treatment that uses sub-threshold stimulation to relieve chronic knee pain caused by osteoarthritis.

You CAN join if:

  • You are 18 years or older

  • Have had knee pain from arthritis for at least 3 months that limits what you can do (pain level 6 or higher on a 1-10 scale)

  • Your knee X-rays show moderate arthritis (Grade 2 or 3)

  • Have tried at least two other treatments like physical therapy, steroid shots, or pain pills that didn't work well enough

  • Can understand the study and attend all follow-up visits

  • Get good but temporary pain relief from a nerve injection test

You CANNOT join if:

  • You have severe arthritis (Grade 4) or other knee pain is worse than your target knee

  • You are pregnant, planning to become pregnant, or breastfeeding

  • You have a pacemaker or other implanted medical devices

  • You have uncontrolled depression or other serious mental health conditions

  • You have serious medical problems like heart disease, liver problems, or breathing issues

  • Your BMI is over 40

  • You've had recent knee procedures (within 2-4 weeks depending on the type)

What happens during the study?

Step 1: Screening and Testing

  • Meet with the research team to see if you qualify

  • Get a test injection near your knee nerve with numbing medicine

  • Only people who get good temporary pain relief (more than 75%) can continue

Step 2: Trial Period

  • Get a temporary device placed near your knee nerve using local numbing medicine

  • Wear the device for 7 days to test if it helps your pain

  • Only people who get good pain relief (50% or better) can continue

Step 3: Permanent Device

  • If the trial works, get a permanent wireless device placed under your skin

  • This is done in an operating room with sedation and local numbing

  • The device stays turned off for 10 days to let you heal

Step 4: Study Period

  • Get randomly assigned to either active treatment or inactive treatment (placebo)

  • Neither you nor your doctor will know which group you're in for the first month

  • Have follow-up visits at 1 week, 1 month, 3 months, and 6 months

  • After 1 month, everyone learns which group they were in, and inactive devices get turned on

  • Follow-up phone calls at 12, 18, and 24 months

What are the benefits and risks?

Potential Benefits:

  • Significant reduction in knee pain

  • Better ability to walk and move around

  • Improved quality of life

  • Less need for pain medications

Potential Risks:

  • Surgical risks like infection, bleeding, or device problems

  • The device might not work for everyone

  • Some people might need the device removed

  • Follow-up procedures might be needed

Time commitment

The study lasts about 2 years total, but most visits happen in the first 6 months. You'll need to:

  • Attend several screening visits

  • Have 2-3 minor procedures

  • Come to follow-up visits at 1 week, 1 month, 3 months, and 6 months

  • Take follow-up phone calls at 12, 18, and 24 months

How to get involved

If you're interested in learning more about this study, contact the research team. They can answer your questions and help you determine if this study might be right for you.

Hemant Kalia