Osteoarthritis, KneeNCT06328153
Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis
A study testing Fu's Subcutaneous Needling and Celecoxib in people with Osteoarthritis, Knee, run by Guangdong Provincial Hospital of Traditional Chinese Medicine.
Trial summary
The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are: Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Fu's Subcutaneous Needling and Celecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 1 Mar 2026
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 60-80 years old.
- BMI<28.
- Clinical diagnosis of knee osteoarthritis.
- Kellgren-Lawrence grade 1-3.
- Knee pain score > 3 on an 10-point numerical rating scale (VAS).
- Having no obvious deformity.
- Having not taken other medication and other modalities of treatment in the last 3 months.
- Voluntary and capable of signing the informed consent form.
Who cannot join
- Non-primary knee osteoarthritis, such as gouty arthritis and hemophilic arthritis, is caused by serious violence and the structure of the knee joint is damaged.
- Patients with other diseases that may cause lower limb pain, such as lumbar disc herniation and lumbar spinal stenosis.
- Patients with lower extremity vascular disease.
- Having a history of knee surgery in the past 6 months.
- Receiving drugs related to knee osteoarthritis or the internal and external treatment of traditional Chinese Medicine in the past 3 months.
- Severe systemic or lower limb local skin disease.
- Contraindications to NSAIDs, such as after coronary artery bypass grafting, active peptic ulcer, severe heart failure, etc.
- With any unstable medical or psychiatric illness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial
The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:
Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.
Read more
Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?
Participants will:
- Will be randomly assigned to 2 groups. There will be 30 participants in each group.
- A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.
- Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.
Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice.
Read the detailed description
This study was a randomised, parallel-controlled, single-center prospective clinical study, which included 60 participants, with an FSN group (n=30) and a drug group (n=30). All patients will give informed consent before participation and the trial is initiated after approval. The Fu's subcutaneous needling(FSN) group underwent FSN treatment 3 times a week for 2 weeks, while the drug group received oral celecoxib 0.2 g/day for 2 weeks, with a follow-up period of 2 weeks after the completion of treatment. The primary outcome will be the visual analog scale（VAS）after two weeks of treatment. The secondary outcomes will be self-reported knee stiffness using the WOMAC Index, joint active range of motion test, three-dimensional gait analysis, and Shear wave elastic imaging technology analysis in lower limb muscles. The results of this trial will be disseminated through publication in peer-reviewed journals.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Fu's Subcutaneous Needling, Celecoxib
- Keywords
- Knee Osteoarthritis, Fu's Subcutaneous Needling, Gait analysis, muscle elasticity
- 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 NeedlingDevice
Also called FSN, Fu's Subcutaneous Needling Treatment, FSN Treatment, Floating Needle
Operation of the FSN will follow the KOA's Fu's Subcutaneous Needling Treatment Code of Practice24. After routine disinfection, a disposable Fu's subcutaneous needle ( Nanjing-Paifu Medical Technology Co., Ltd., Jiangsu, China ) is inserted parallel into the subcutaneous loose connective tissue of the pathological tight muscles ( gastrocnemius muscle, tibial anterior muscle and quadriceps femoris muscle ). The FSN needle is operated in a swaying movement. The fan angle is approximately 60°; perform a total of 45 round trips in 30 seconds. Swaying is accompanied by reperfusion approach: 20 sweeps with 10 seconds of reperfusion approach as a group, 3 groups for each pathological tight muscle. The reperfusion approach requires active, short and sharp contractions of the pathological tight muscle. The muscle alternates contraction and relaxation. The FSN group is treated 3 times a week for 2 weeks.
CelecoxibDrug
Also called Nonsteroidal Antiinflammatory Drugs, NSAIDs
Participants in the drug group will receive celecoxib (capsule) 200mg every day continuously for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FSN group | Experimental | Fu's subcutaneous needling (FSN) is a new type of acupuncture. Patients in the FSN Group only received FSN treatment, without other interventions such as oral drugs or topical drugs. Receives: Device: Fu's Subcutaneous Needling |
| Drug Group | Active comparator | Celecoxib is a member of Nonsteroidal Antiinflammatory Drugs (NSAIDs) and the most commonly used treatment for knee osteoarthritis. Patients in the drug group received only oral celecoxib, no other oral or topical drugs, and no other physical therapies. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
Visual analogue scale (VAS) is used to assess pain. A "0" indicates no pain or no limitation of function and gets worse as the value increases, and a "10" indicates severe pain (refractory to analgesic medication) or extreme limitation of function
Measured: Baseline and the 14th day after the start of treatment
Secondary outcomes (3)
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment.
Visual analogue scale (VAS) is used to assess pain. A "0" indicates no pain or no limitation of function and gets worse as the value increases, and a "10" indicates severe pain (refractory to analgesic medication) or extreme limitation of function
Measured: Baseline and the 7th day, the 28th day and the 42th day after the start of treatment
Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment.
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a scoring system that is applicable to the assessment of knee osteoarthritis. The severity of arthritis and the efficacy of treatment is evaluated according to the relevant symptoms and signs of patients. The rating scale includes 24 questions in 3 aspects of pain, stiffness and dysfunction, and there are 2 methods of calculation: 5-point scale (0-4) and 11-point scale (0-10), corresponding to a maximum score of 96 and 240, respectively. The higher the score, the more severe the subjective feeling of the symptoms.
Measured: Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment.
Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment.
A goniometer is used. In general, for healthy people, the active range of motion (ROM) of the knee joint is: extension-flexion (0°-135°). Limited flexion or extension of the knee, or a range beyond the normal range, may be the manifestation of knee disease.
Measured: Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Sun, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328153
- Sponsor's protocol ID
- BF2022-101
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Details of individual participant data (IPD) sharing still need to be determined with institutional ethics committees.
Publications
Huang H, Liu R, Shao J, Chen S, Sun J, Zhu J. Biomechanically based Fu's subcutaneous needling treatment for senile knee osteoarthritis: protocol for a randomized controlled trial. J Orthop Surg Res. 2024 Jul 8;19(1):394. doi: 10.1186/s13018-024-04878-7.
PubMed 38978119
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06328153
- Acronym / sponsor ID
- BF2022-101
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Osteoarthritis, Fu's Subcutaneous Needling, Gait analysis, muscle elasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 25 Mar 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.
The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:
Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.
Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?
Participants will:
- Will be randomly assigned to 2 groups. There will be 30 participants in each group.
- A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.
- Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.
Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice.
Detailed description
This study was a randomised, parallel-controlled, single-center prospective clinical study, which included 60 participants, with an FSN group (n=30) and a drug group (n=30). All patients will give informed consent before participation and the trial is initiated after approval. The Fu's subcutaneous needling(FSN) group underwent FSN treatment 3 times a week for 2 weeks, while the drug group received oral celecoxib 0.2 g/day for 2 weeks, with a follow-up period of 2 weeks after the completion of treatment. The primary outcome will be the visual analog scale（VAS）after two weeks of treatment. The secondary outcomes will be self-reported knee stiffness using the WOMAC Index, joint active range of motion test, three-dimensional gait analysis, and Shear wave elastic imaging technology analysis in lower limb muscles. The results of this trial will be disseminated through publication in peer-reviewed journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSN group | Experimental | Device: Fu's Subcutaneous NeedlingFu's subcutaneous needling (FSN) is a new type of acupuncture. Patients in the FSN Group only received FSN treatment, without other interventions such as oral drugs or topical drugs. |
| Drug Group | Active comparator | Drug: CelecoxibCelecoxib is a member of Nonsteroidal Antiinflammatory Drugs (NSAIDs) and the most commonly used treatment for knee osteoarthritis. Patients in the drug group received only oral celecoxib, no other oral or topical drugs, and no other physical therapies. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 60-80 years old.
- BMI<28.
- Clinical diagnosis of knee osteoarthritis.
- Kellgren-Lawrence grade 1-3.
- Knee pain score > 3 on an 10-point numerical rating scale (VAS).
Key exclusion criteria (8 listed)
- Non-primary knee osteoarthritis, such as gouty arthritis and hemophilic arthritis, is caused by serious violence and the structure of the knee joint is damaged.
- Patients with other diseases that may cause lower limb pain, such as lumbar disc herniation and lumbar spinal stenosis.
- Patients with lower extremity vascular disease.
- Having a history of knee surgery in the past 6 months.
- Receiving drugs related to knee osteoarthritis or the internal and external treatment of traditional Chinese Medicine in the past 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 |
|---|---|---|
| Fu's Subcutaneous NeedlingAlso: FSN, Fu's Subcutaneous Needling Treatment, FSN Treatment, Floating NeedleOperation of the FSN will follow the KOA's Fu's Subcutaneous Needling Treatment Code of Practice24. After routine disinfection, a disposable Fu's subcutaneous needle ( Nanjing-Paifu Medical Technology Co., Ltd., Jiangsu, China ) is inserted parallel into the subcutaneous loose connective tissue of the pathological tight muscles ( gastrocnemius muscle, tibial anterior muscle and quadriceps femoris muscle ). The FSN needle is operated in a swaying movement. The fan angle is approximately 60°; perform a total of 45 round trips in 30 seconds. Swaying is accompanied by reperfusion approach: 20 sweeps with 10 seconds of reperfusion approach as a group, 3 groups for each pathological tight muscle. The reperfusion approach requires active, short and sharp contractions of the pathological tight muscle. The muscle alternates contraction and relaxation. The FSN group is treated 3 times a week for 2 weeks. | Device | FSN group |
| CelecoxibAlso: Nonsteroidal Antiinflammatory Drugs, NSAIDsParticipants in the drug group will receive celecoxib (capsule) 200mg every day continuously for 2 weeks. | Drug | Drug Group |
Primary outcome
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
Time frame: Baseline and the 14th day after the start of treatment
Visual analogue scale (VAS) is used to assess pain. A "0" indicates no pain or no limitation of function and gets worse as the value increases, and a "10" indicates severe pain (refractory to analgesic medication) or extreme limitation of function
3 secondary outcomes
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment.
Time frame: Baseline and the 7th day, the 28th day and the 42th day after the start of treatment
Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment.
Time frame: Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment.
Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment.
Time frame: Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 38978119Huang H, Liu R, Shao J, Chen S, Sun J, Zhu J. Biomechanically based Fu's subcutaneous needling treatment for senile knee osteoarthritis: protocol for a randomized controlled trial. J Orthop Surg Res. 2024 Jul 8;19(1):394. doi: 10.1186/s13018-024-04878-7.
- Individual participant dataSharing planned: Undecided. Details of individual participant data (IPD) sharing still need to be determined with institutional ethics committees.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's Subcutaneous Needling and Celecoxib in people with Osteoarthritis, Knee, run by Guangdong Provincial Hospital of Traditional Chinese Medicine.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Sun, M.D. (8618188731038, sunj3610@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment. (time frame: Baseline and the 14th day after the start of treatment). 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 NCT06328153, which also lists 1 linked publication.
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 Mar 2024.