Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis

NCT06328153 | Not Yet Recruiting DMC

• 1 other identifier: BF2022-101
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Osteoarthritis, Knee

Keywords

Knee Osteoarthritis; Fu's Subcutaneous Needling; Gait analysis; muscle elasticity

Outcome Measures

Primary Outcomes (1)

• 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 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.

  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.

  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.

  Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment

Other Outcomes (3)

• Change from Baseline in the data of the Three-dimensional gait analysis at the 7th day and 14th day after the start of treatment.

  Baseline and the 7th day, the 14th day after the start of treatment

• 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.

  Baseline and the 7th day, the 14th day after the start of treatment

• Incidence of Treatment-Emergent Adverse Events

  Up to 6 weeks.

Study Arms (2)

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.

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.

Drug: Celecoxib

Interventions

Fu's Subcutaneous Needling 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.

Also known as: FSN, Fu's Subcutaneous Needling Treatment, FSN Treatment, Floating Needle, Floating Needle Treatment

FSN group

Celecoxib DRUG

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

Also known as: Nonsteroidal Antiinflammatory Drugs, NSAIDs

Drug Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Related Publications (1)

• 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.

  PMID: 38978119 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Celecoxib; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Central Study Contacts

Jian Sun, M.D.

CONTACT

8618188731038; sunj3610@163.com

Hai Huang, M.M.

CONTACT

8618022214688; 18022214688@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean of College

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 25, 2024
• Study Start: March 15, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-03