The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Osteoarthritis (OA) of the Knee

• Registration Number: NCT06702046
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Status Verified: 2025-02
• Study Start: 2025-02-24
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index	From enrollment to the end of treatment at 4 weeks	WOMAC is used to assess pain(5 items), stiffness(2 items), and physical function(17 items) of knee OA with excellent validity and reliability. Higher scores mean worse symptoms with more functional limitation.

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index	12 weeks after completing treatment	WOMAC is used to assess pain(5 items), stiffness(2 items), and physical function(17 items) of knee OA with excellent validity and reliability. Higher scores mean worse symptoms with more functional limitation
visual analogue scale	From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment	Visual analogue scale (VAS) at rest and during activity will be recorded. VAS of pain is obtained using a 10-cm long horizontal line, with 0 cm on the left, indicating no pain, and 10 cm on the right, indicating the most severe pain.
Tampa Scale for Kinesiophobia	From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment	Tampa Scale for Kinesiophobia (TSK-11) is used to evaluate the pain-related fear. It consists of 11 items, each rated on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate greater fear of movement, which can be a significant barrier to rehabilitation and physical activity
World Health Organization Quality of Life-Brief Version	From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment	World Health Organization Quality of Life-Brief Vision (WHOQoL-BREF) was used to assess general health-related quality of life. It consists of total 28 items with 4 domains: physical, psychological, social relationship, and environmental (internal consistency: 0.7-0.77, reliability: 0.76-0.8, with good validity). The scores range from 0 to 100, the higher the score, the better the quality of life
Biodex Stability System	From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment	Biodex Stability System (Biodex Medical Systems, 20 Ramsay Rd, Shirley, NY 11967-4704) was used to evaluate static, dynamic balance, and fall risk. The Biodex Stability System comprises a foot platform, support handle, and display module. The foot platform has two axes with different tilting angles. By adjusting the grade of the tilting angles of the axes, the overall stability index was recorded. A higher score indicated poorer static balance. For the limit of stability test, the investigators measured the displacement of the patient's center of gravity when the platform was tilting on different axes according to the directions displayed randomly on the monitor. Higher scores represented superior dynamic balance
Timed Up and Go	From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment	Timed Up and Go (TUG) test is an assessment used to evaluate participants' mobility and balance. It measures the time it takes for a person to stand up from a seated position, walk three meters, turn around, walk back to the chair, and sit down. The test is reliable for the time score to predict out-door mobility and safety.

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, State, Taiwan