Osteoarthritis (OA) of the KneeNCT06702046
The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis
A study testing transcutaneous pulsed radiofrequency acupuncture in people with Osteoarthritis (OA) of the Knee, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- transcutaneous pulsed radiofrequency acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active infection at the stimulator contact site
- Lack of informed consent
- Any other reason thought likely to result in inability to complete the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, State, 111
Yu-Ting Lin, M.D., +00886-28332211 ext. 2538, M012225@ms.skh.org.tw
About this study
Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.
Read the 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.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- transcutaneous pulsed radiofrequency acupuncture, Sham Comparison
- Keywords
- knee osteoarthritis, transcutaneous pulsed radiofrequency, acupuncture, acupoints
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous pulsed radiofrequency acupunctureDevice
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.
Sham ComparisonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (6)
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
Measured: 12 weeks after completing treatment
visual analogue scale
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.
Measured: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Tampa Scale for Kinesiophobia
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
Measured: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
World Health Organization Quality of Life-Brief Version
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
Measured: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Biodex Stability System
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
Measured: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Timed Up and Go
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.
Measured: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start24 Feb 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702046
- Sponsor's protocol ID
- 20240723R
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06702046
- Acronym / sponsor ID
- 20240723R
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- knee osteoarthritis, transcutaneous pulsed radiofrequency, acupuncture, acupoints
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCPRF acupuncture group | Experimental | Device: transcutaneous pulsed radiofrequency acupunctureThe 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. |
| Sham group | Sham comparator | Device: Sham Comparisonsame 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous pulsed radiofrequency acupunctureFor 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. | Device | TCPRF acupuncture group |
| Sham Comparisonsame 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 group |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 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.
6 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 12 weeks after completing treatment
visual analogue scale
Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Tampa Scale for Kinesiophobia
Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
World Health Organization Quality of Life-Brief Version
Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Biodex Stability System
Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Timed Up and Go
Time frame: From enrollment to the end of treatment at 4 weeks and 12 weeks after completing treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous pulsed radiofrequency acupuncture in people with Osteoarthritis (OA) of the Knee, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ting Lin, M.D. (+886-28332211 ext. 2538, M012225@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.