Clinical trial NCT06328153: Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis
Official title: Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Osteoarthritis
Fu's Subcutaneous Needling
Gait analysis
muscle elasticity
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
timeFrame: Baseline and the 14th day after the start of treatment
Secondary outcomes:
measure: 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.
timeFrame: Baseline and the 7th day, the 28th day and the 42th day after the start of treatment
measure: 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.
timeFrame: Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment.
measure: 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.
timeFrame: Baseline and the 7th day, the 14th day, the 28th day and the 42th day after the start of treatment
Other outcomes:
measure: Change from Baseline in the data of the Three-dimensional gait analysis at the 7th day and 14th day after the start of treatment.
timeFrame: Baseline and the 7th day, the 14th day after the start of treatment
measure: 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.
timeFrame: Baseline and the 7th day, the 14th day after the start of treatment
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 6 weeks.
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