Clinical trial for Knee Osteoarthritis
Official title A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression
ClinicalTrials.gov ID: NCT06906939
What this study is testing
- What it's testing
- This study checks if adding a brain stimulation device to Tai Chi is safe and might help reduce knee pain and depression symptoms.
- Who it's for
- The study is looking for 30 people who have knee arthritis pain and moderate to severe depression.
- What's involved
- Participants will do Tai Chi exercises and receive a painless magnetic pulse to the brain (rTMS) during visits.
- Time commitment
- The study involves a series of visits for Tai Chi and brain stimulation, but the total duration is not specified.
- Phase 1: an early, usually small safety study
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 95
You may be able to join if
- Age 50 or years older.
- Chronic pain as indicated by complaints of pain in one or more body regions for 6 months or more.
- Fulfills the American College of Rheumatology (ACR) criteria for symptomatic knee OA and had radiographic evidence of tibiofemoral or patellofemoral...
- Knee pain for \>- 3 months and on most days of the past month
- Patient PROMIS Pain Interference score \>=40 (100 mm VAS);
You likely can't join if
- Change in psychotropic or pain medication during the past four months. This will minimize the amount of symptom change due to medication alterations.
- A current diagnosis of mania, hypomania, unstable bipolar disorder, psychotic disorder or a history of psychosis, as noted in electronic medical...
- Dementia, neurological disease, cancer, cardiovascular disease, metabolic disease, renal disease, liver disease, or other serious medical conditions...
- No current medical conditions that limit ability to participate safely in moderate exercise.
- Meets criteria for alcohol or drug dependence within the past three months.
- Currently practicing Tai Chi
See the full eligibility criteria
- Age 50 or years older.
- Chronic pain as indicated by complaints of pain in one or more body regions for 6 months or more. Participants who meet at least one of the following criteria for Osteoarthritis (OA)
- Fulfills the American College of Rheumatology (ACR) criteria for symptomatic knee OA and had radiographic evidence of tibiofemoral or patellofemoral OA (defined as the presence of a definite osteophyte in the...
- Knee pain for \>- 3 months and on most days of the past month
- Patient PROMIS Pain Interference score \>=40 (100 mm VAS);
- Access to computer or device for telehealth delivery;
- Able to walk without cane or assistance.
- Psychological distress expressed as depression: Persistent depressive symptomatology (Beck Depression Inventory)\>20 in two consecutive screenings within 2-3 weeks.
- Willingness to complete the 3-month study, including twice-a-week Tai Chi sessions and rTMS, with additional 6 and 12 month follow up
- Approval to participate in program by patient's primary care provider or another member of their medical team (e.g. cardiologist).
- Ability to pass the Physical Activity Readiness Questionnaire (PAR-Q) administered in the telephone screening.
- Internet access \>No contraindications to rTMS
- Change in psychotropic or pain medication during the past four months. This will minimize the amount of symptom change due to medication alterations.
- A current diagnosis of mania, hypomania, unstable bipolar disorder, psychotic disorder or a history of psychosis, as noted in electronic medical record.
- Dementia, neurological disease, cancer, cardiovascular disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the Tai Chi or Exercise programs...
- No current medical conditions that limit ability to participate safely in moderate exercise.
- Meets criteria for alcohol or drug dependence within the past three months.
- Currently practicing Tai Chi
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.