Clinical trial NCT06702046: The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis
Official title: The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Keywords: knee osteoarthritis
transcutaneous pulsed radiofrequency
acupuncture
acupoints
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

Detailed description: With the aging population, knee osteoarthritis (KOA) has become a major issue affecting functional living and causing socioeconomic burdens. Its etiology includes biomechanical abnormalities, genetics, hormones, and environmental factors. KOA causes pain, stiffness, and muscle weakness, affecting daily activities and quality of life. Previous studies have shown that traditional acupuncture or electroacupuncture can improve pain and function in knee osteoarthritis. In recent years, pulsed radiofrequency therapy has gradually been applied for pain control in KOA. However, both treatments are invasive, and patients may fear and avoid needle insertion, which also has a higher risk of complications. This study aims to combine the strengths of both treatments by using transcutaneous pulsed radiofrequency(TCPRF) at acupuncture points. This non-invasive treatment approach aims to achieve effective pain control, allowing patients to participate more actively in rehabilitation therapy.

Eligibility criteria: Inclusion Criteria:

* Age from 45 to 85 year-old with knee pain for more than six months
* Fulfill the combined clinical and radiographic criteria of knee OA established by the American College of Rheumatology with a Kellgren and Lawrence score of 2 or greater
* Pain score above 3 (range 0-10 on the visual analog scale; higher scores indicate greater pain
* Could participate in 4 weeks of treatment and 3 months of follow-up

Exclusion Criteria:

* Knee OA combined with any infection, inflammation, autoimmune disease, or fracture
* History or underlying disease that would affect posture and balance, such as malignancy, dizziness, vertigo, or stroke
* Ever underwent any type of knee operation or internal fixation
* Pregnant or planning to become pregnant
* Receiving other treatment for knee OA in previous 3 months
* History of epilepsy, electronic devices implanted in the body
* Active infection at the stimulator contact site
* Lack of informed consent
* Any other reason thought likely to result in inability to complete the trial

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 12 weeks after completing treatment
measure: visual analogue scale
timeFrame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
measure: Tampa Scale for Kinesiophobia
timeFrame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
measure: World Health Organization Quality of Life-Brief Version
timeFrame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
measure: Biodex Stability System
timeFrame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
measure: Timed Up and Go
timeFrame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
state: State
Study officials:
References: