Knee OsteoarthritisNCT04356651
Fu's Subcutaneous Needling Treatment for Knee Osteoarthritis
A study testing Fu's subcutaneous needling(FSN) and Transcutaneous Electric Nerve Stimulation in people with Knee Osteoarthritis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The population affected by degenerative knee arthritis is very large. The investigator performed Fu's subcutaneous needling (FSN). This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling (FSN) therapy on patellar pain in patients… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Fu's subcutaneous needling(FSN) and Transcutaneous Electric Nerve Stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2020to 10 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Volunteers who are older than 50 years old and can cooperate with the experiment.
- 2.Established diagnosis of unilateral or bilateral degenerative knee arthritis. 3.There is a local trigger point around the unilateral or bilateral knee joint which on the muscle of Vastus lateralis, Vastus medialis, Gastrocnemius, or Tibialis anterior.
Who cannot join
- 1.There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- 2.There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- 3.Have received knee surgery. 4.People with central or peripheral nerve disease. 5.Cognitive impairment, unable to cooperate with the experimenter. 6.Patients currently receiving other treatments for knee osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fu's Subcutaneous Needling for Knee Osteoarthritis: a Single-blind and Randomized-controlled Trial
The population affected by degenerative knee arthritis is very large. The investigator performed Fu's subcutaneous needling (FSN). This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling (FSN) therapy on patellar pain in patients with degenerative arthritis.
Read the detailed description
The population affected by degenerative knee arthritis is very large. According to a survey conducted by the Ministry of Health and Welfare, the prevalence of osteoarthritis of the knee in Taiwan is about 3.5 million people, accounting for about 15% of the total population. Its effects are a heavy burden on socio-economic costs, and in addition to being included in medical expenses, serious cases can lead to incapacity to work; therefore, the disease is an important factor in causing disability and disability First, it is worth our attention.
Floating needle is a kind of dry needle therapy, which has been used in the treatment of degenerative arthritis for more than 20 years. It has been clearly annotated in the treatment strategy that it uses disposable floating needle needles at the superficial subcutaneous fascia, Parallel to the muscle to sweep away, and with reperfusion activities, muscle pain caused by muscle fascia and soft tissue pain with immediate and good pain relief effect, but still lack of treatment and rigorous evaluation of the establishment.
For the reasons of the degenerative arthritis pain, the clinical observation is not entirely due to the cause of joint deformity or cartilage damage, soft tissue lesions around the knee is also a common source of pain, the use of floating needle for the diagnosis of soft tissue injury , And observed its efficacy, which is also the core of this study.
This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of floating needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lesquesne index, the Muscle Tension Changes in the Lower Extremities, and Gyko .
- Conditions
- Knee Osteoarthritis
- Being tested
- Fu's subcutaneous needling(FSN), Transcutaneous Electric Nerve Stimulation
- Keywords
- Fu's subcutaneous needling, myofascial trigger point, muscle tone
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's subcutaneous needling(FSN)Procedure or surgery
In this study, physician will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin from anterior superior iliac spine(ASIS) to 1/3 superior border of patella. Then the physician will push forward the needle parallel to the skin surface. The physician will sway the needle 45 times in 30 seconds. After swaying the needle, the physician will instruct the subject to do sole dorsiflexion for 10 seconds resisting the physician's opposite force, then the subject take a rest for 10 seconds. The above actions are 3 repetitions. Then the subject do knee flexion and extension for 10 seconds, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the physician will take out the needle to finish the treatment.
Transcutaneous Electric Nerve StimulationProcedure or surgery
Transcutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10Hz) with an intensity that produces motor contraction.
| Study group | Role | What they receive |
|---|---|---|
| Fu's subcutaneous needling(FSN) | Experimental | In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. Receives: Procedure: Fu's subcutaneous needling(FSN) |
| Transcutaneous Electric Nerve Stimulation | Active comparator | In this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation on Day1, Day2 and Day4, in the total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. Receives: Procedure: Transcutaneous Electric Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scales
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end The right shift indicates more and more pain. Take a pen and let the patient draw a short line vertically on the line, representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases, it can represent the treatment is helpful for the improvement of the patient's pain.
Measured: 1 day
Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom
Measured: 1 day
Muscle tension
Muscle tension is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness automatically and get a value to represent the muscle tension. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.
Measured: 1 day
GyKo
GyKo is an inertial measurement tool for the analysis of the movement of any body segment
Measured: 1 day
WOMAC
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Measured: 1 day
Lequesne'Index
A pain scale measures a patient's pain intensity or other features.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start7 Jul 2020
- Primary completion31 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Wei Chou, China Medical University Hospital
- Investigators
- Li-Wei Chou,, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356651
- Sponsor's protocol ID
- CMUH107-REC3-027
- Status last verified
- Feb 2021
- First submitted
- 20 Apr 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chiu PE, Fu Z, Sun J, Jian GW, Li TM, Chou LW. Efficacy of Fu's Subcutaneous Needling in Treating Soft Tissue Pain of Knee Osteoarthritis: A Randomized Clinical Trial. J Clin Med. 2022 Dec 2;11(23):7184. doi: 10.3390/jcm11237184.
PubMed 36498758Chiu PE, Fu Z, Jian GW, Huang CH, Li TM, Chou LW. Evaluating Effectiveness of Fu's Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial. J Pain Res. 2021 Oct 9;14:3163-3172. doi: 10.2147/JPR.S333299. eCollection 2021.
PubMed 34675644
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fu's Subcutaneous Needling for Knee Osteoarthritis: a Single-blind and Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04356651
- Acronym / sponsor ID
- CMUH107-REC3-027
- Conditions
- Knee Osteoarthritis
- Keywords
- Fu's subcutaneous needling, myofascial trigger point, muscle tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 22 Apr 2020 (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.
The population affected by degenerative knee arthritis is very large. The investigator performed Fu's subcutaneous needling (FSN). This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling (FSN) therapy on patellar pain in patients with degenerative arthritis.
Detailed description
The population affected by degenerative knee arthritis is very large. According to a survey conducted by the Ministry of Health and Welfare, the prevalence of osteoarthritis of the knee in Taiwan is about 3.5 million people, accounting for about 15% of the total population. Its effects are a heavy burden on socio-economic costs, and in addition to being included in medical expenses, serious cases can lead to incapacity to work; therefore, the disease is an important factor in causing disability and disability First, it is worth our attention.
Floating needle is a kind of dry needle therapy, which has been used in the treatment of degenerative arthritis for more than 20 years. It has been clearly annotated in the treatment strategy that it uses disposable floating needle needles at the superficial subcutaneous fascia, Parallel to the muscle to sweep away, and with reperfusion activities, muscle pain caused by muscle fascia and soft tissue pain with immediate and good pain relief effect, but still lack of treatment and rigorous evaluation of the establishment.
For the reasons of the degenerative arthritis pain, the clinical observation is not entirely due to the cause of joint deformity or cartilage damage, soft tissue lesions around the knee is also a common source of pain, the use of floating needle for the diagnosis of soft tissue injury , And observed its efficacy, which is also the core of this study.
This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of floating needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lesquesne index, the Muscle Tension Changes in the Lower Extremities, and Gyko .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fu's subcutaneous needling(FSN) | Experimental | Procedure: Fu's subcutaneous needling(FSN)In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. |
| Transcutaneous Electric Nerve Stimulation | Active comparator | Procedure: Transcutaneous Electric Nerve StimulationIn this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation on Day1, Day2 and Day4, in the total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Volunteers who are older than 50 years old and can cooperate with the experiment.
- 2.Established diagnosis of unilateral or bilateral degenerative knee arthritis. 3.There is a local trigger point around the unilateral or bilateral knee joint which on the muscle of Vastus lateralis, Vastus medialis, Gastrocnemius, or Tibialis anterior.
Key exclusion criteria (3 listed)
- 1.There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
- 2.There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- 3.Have received knee surgery. 4.People with central or peripheral nerve disease. 5.Cognitive impairment, unable to cooperate with the experimenter. 6.Patients currently receiving other treatments for knee osteoarthritis
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 |
|---|---|---|
| Fu's subcutaneous needling(FSN)In this study, physician will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin from anterior superior iliac spine(ASIS) to 1/3 superior border of patella. Then the physician will push forward the needle parallel to the skin surface. The physician will sway the needle 45 times in 30 seconds. After swaying the needle, the physician will instruct the subject to do sole dorsiflexion for 10 seconds resisting the physician's opposite force, then the subject take a rest for 10 seconds. The above actions are 3 repetitions. Then the subject do knee flexion and extension for 10 seconds, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the physician will take out the needle to finish the treatment. | Procedure or surgery | Fu's subcutaneous needling(FSN) |
| Transcutaneous Electric Nerve StimulationTranscutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10Hz) with an intensity that produces motor contraction. | Procedure or surgery | Transcutaneous Electric Nerve Stimulation |
Primary outcome
Visual Analog Scales
Time frame: 1 day
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end The right shift indicates more and more pain. Take a pen and let the patient draw a short line vertically on the line, representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases, it can represent the treatment is helpful for the improvement of the patient's pain.
Pressure Pain Threshold
Time frame: 1 day
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom
Muscle tension
Time frame: 1 day
Muscle tension is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness automatically and get a value to represent the muscle tension. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.
GyKo
Time frame: 1 day
GyKo is an inertial measurement tool for the analysis of the movement of any body segment
WOMAC
Time frame: 1 day
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Lequesne'Index
Time frame: 1 day
A pain scale measures a patient's pain intensity or other features.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 36498758Chiu PE, Fu Z, Sun J, Jian GW, Li TM, Chou LW. Efficacy of Fu's Subcutaneous Needling in Treating Soft Tissue Pain of Knee Osteoarthritis: A Randomized Clinical Trial. J Clin Med. 2022 Dec 2;11(23):7184. doi: 10.3390/jcm11237184.
- Derived from this study: PubMed 34675644Chiu PE, Fu Z, Jian GW, Huang CH, Li TM, Chou LW. Evaluating Effectiveness of Fu's Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial. J Pain Res. 2021 Oct 9;14:3163-3172. doi: 10.2147/JPR.S333299. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Li-Wei Chou,, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's subcutaneous needling(FSN) and Transcutaneous Electric Nerve Stimulation in people with Knee Osteoarthritis, run by China Medical University 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Feb 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scales (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04356651, which also lists 2 linked publications.
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 25 Feb 2021.