Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328153
• Other study ID #: BF2022-101
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Jian Sun, M.D.
• Phone: 8618188731038
• Email: sunj3610[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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:

1. Will be randomly assigned to 2 groups. There will be 30 participants in each group.

2. 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.

3. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Fu's Subcutaneous Needling
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.

Drug:
• Celecoxib
Participants in the drug group will receive celecoxib (capsule) 200mg every day continuously for 2 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in the data of the Three-dimensional gait analysis at the 7th day and 14th day after the start of treatment.	The Opti_Knee 3D motion analysis system is used. Participants are made to walk continuously on the exercise board in a natural habitual position at a constant speed of 3.0km/h. The system collects gait data under appropriate working conditions, including six degrees of freedom data: femoral relative to tibial internal/external rotation angles, internal/external rotation angles, flexion/extension angles, anterior/posterior displacements, superior/inferior displacements, and internal/external displacements).The collected data help to analyze the mobility of the knee and even the whole lower limb.	Baseline and the 7th day, the 14th day after the start of treatment
Other	Change from Baseline in the data of the shear wave elastic imaging technology analysis at the 7th day and 14th day after the start of treatment.	Supersonic Colour Doppler Ultrasound Diagnostic Unit is used to detect and calculate the mean value of Young's modulus for the muscle tissues of the lower limb. Each frozen image is repeated 3 times, and the mean values of 2 qualified sampling boxes is taken for statistical analysis.	Baseline and the 7th day, the 14th day after the start of treatment
Other	Incidence of Treatment-Emergent Adverse Events	Unfavourable or unintended events in participants in the study are documented using a pre-set questionnaire and appropriate management measures will be taken. If the subject develops a more serious adverse reaction and the investigator considers the subject unfit to proceed with the study, the trial will be terminated.	Up to 6 weeks.
Primary	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	Baseline and the 14th day after the start of treatment
Secondary	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	Baseline and the 7th day, the 28th day and the 42th day after the start of treatment
Secondary	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.	Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment.
Secondary	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.	Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment