Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis

NCT ID: NCT06328153

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2026-03-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FSN group

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.

Group Type: EXPERIMENTAL

Fu's Subcutaneous Needling

Intervention Type: DEVICE

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 Group

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.

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Celecoxib

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

Intervention Type: DRUG

Other Intervention Names

FSN; Fu's Subcutaneous Needling Treatment; FSN Treatment; Floating Needle; Floating Needle Treatment; Nonsteroidal Antiinflammatory Drugs; NSAIDs

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jian Sun

Vice Dean of College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jian Sun, M.D.

Role: CONTACT

sunj3610@163.com

8618188731038

Hai Huang, M.M.

Role: CONTACT

18022214688@126.com

8618022214688

References

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.

Reference Type: DERIVED

PMID: 38978119 (View on PubMed)

Other Identifiers

BF2022-101

Identifier Type: -

Identifier Source: org_study_id