The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

NCT06702046 | Recruiting

• 1 other identifier: 20240723R
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis (OA) of the Knee

Keywords

knee osteoarthritis; transcutaneous pulsed radiofrequency; acupuncture; acupoints

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index

  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.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (6)

• Western Ontario and McMaster Universities Osteoarthritis Index

  12 weeks after completing treatment

• visual analogue scale

  From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment

• Tampa Scale for Kinesiophobia

  From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment

• World Health Organization Quality of Life-Brief Version

  From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment

• Biodex Stability System

  From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment

Study Arms (2)

TCPRF acupuncture group

EXPERIMENTAL

The investigators choose ST34 (Liangqiu), SP10 (Xuehai), GB34 (Yanglingquan), SP9 (Yinlingquan) around the affected knee. The TCPRF device is a wearable modality with innovative pulse radiofrequency technology aimed at alleviating symptomatic chronic pain, which revealed that UHF (500-kHz sine wave, 2-Hz frequency with a 25-ms pulse). It was attached to the electrode pad through magnetic attraction. A 500-KHz stimulus was delivered. The symmetric two-phase sine wave has a 2-Hz frequency witha 25-ms pulse width. The treatment has 15 min per time. treatment is administered for 30 minutes each session, divided into two 15-minute phases. After the first 15 minutes, the treatment is paused and then restarted for an additional 15 minutes. The output peak current was 13.2 mA and the output peak voltage was 6.6 V at 500 Ω.

Device: transcutaneous pulsed radiofrequency acupuncture

Sham group

SHAM COMPARATOR

same protocol will be done on the same acupoints, but the machine will be turn off interiorly. Therefore, although the machine still has lights and a vibrating sensation, it will not release PRF waves.

Device: Sham Comparison

Interventions

transcutaneous pulsed radiofrequency acupuncture DEVICE

For the TCPRF acupuncture group, the investigators choose ST34 (Liangqiu), SP10 (Xuehai), GB34 (Yanglingquan), SP9 (Yinlingquan) around the affected knee. The TCPRF device is a wearable modality with innovative pulse radiofrequency technology aimed at alleviating symptomatic chronic pain, which revealed that UHF (500-kHz sine wave, 2-Hz frequency with a 25-ms pulse). It was attached to the electrode pad through magnetic attraction. A 500-KHz stimulus was delivered. The symmetric two-phase sine wave has a 2-Hz frequency witha 25-ms pulse width. The treatment has 15 min per time. Electrical stimulation is administered for 30 minutes each session, divided into two 15-minute phases. After the first 15 minutes, the treatment is paused and then restarted for an additional 15 minutes. The output peak current was 13.2 mA and the output peak voltage was 6.6 V at 500 Ω.

TCPRF acupuncture group

Sham Comparison DEVICE

same protocol will be done on the same acupoints, but the machine will be turn off interiorly. Therefore, although the machine still has lights and a vibrating sensation, it will not release PRF waves.

Sham group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, State, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yu-Ting Lin, M.D.

CONTACT

+886-28332211; M012225@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)