Effect of Inspiratory Muscle Training on Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Visual analogue scale
研究概览
简要总结
Knee osteoarthritis (KOA) is a common joint disease that causes chronic pain and limits daily activities. Current treatments, such as painkillers or surgery, have limitations like side effects or high costs. This study will test whether a safe, non-drug intervention-inspiratory muscle training (breathing exercises against resistance)-can reduce knee pain in people with KOA. The training may work by lowering inflammation and improving the brain's modulation of pain.
Eighty patients aged ≥55 years with confirmed KOA and frequent knee pain will be enrolled. Participants will be randomly assigned to either an 8-week inspiratory muscle training program (5 sessions per week, with gradually increasing resistance) or a sham (very low resistance) training program. Neither the patients nor the researchers assessing the outcomes will know who is in which group.
The main outcome is change in knee pain measured by a visual analog scale (VAS). Secondary outcomes include blood markers of inflammation (TNF-α, IL-6, IL1β), physical function, the Knee injury and Osteoarthritis Outcome Score (KOOS), inspiratory muscle strength, activity level, sleep quality, and quality of life. To explore underlying mechanisms, outcomes included heart rate variability (HRV) as an indicator of autonomic nervous system function, and brain functional connectivity in the prefrontal cortex using functional near-infrared spectroscopy (fNIRS) are collected. These mechanistic assessments will be performed at baseline and at the end of 8-week intervention. Additional follow-up assessments for clinical outcomes will be done at 3 and 6 months after the training ends. Any side effects or adverse events will be recorded.
This study will provide high-quality evidence on whether inspiratory muscle training is an effective and safe complementary treatment for knee pain in people with knee OA, and will offer new insights into the mechanisms underlying its analgesic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, outcome assessors, and data analyst are blinded. Care provider is not blinded.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55 years or older.
- •Knee osteoarthritis (Kellgren-Lawrence grade ≥ 2).
- •Knee pain (Visual Analogue Scale, VAS ≥ 3) on the most days in the past month.
- •Able to walk independently without assitive devices.
排除标准
- •History of knee replacement surgery, meniscus surgery, or ligament surgery.
- •Received corticosteroid injection within the previous three weeks.
- •Diagnosed with rheumatoid arthritis.
- •Unstable angina, recent myocardial infarction, uncontrolled cardiac arrhythmia, or severe heart failure.
- •History of stroke.
- •Currently receiving steroid therapy, hormonal therapy, or cancer chemotherapy.
- •Pneumothorax, pulmonary bullae, lung surgery within the past 12 months, unstable asthma, or severe dyspnea at rest.
- •Unable to understand the study procedures and potential risks.
研究组 & 干预措施
Inspiratory Muscle Training
5 sessions/week for 8 weeks. Load starts at 50% MIP for 40 reps, increases to 80% MIP for 60 reps from week 5, then adjusted weekly to 80% of updated MIP. Device: threshold inspiratory muscle trainer.
干预措施: Inspiratory muscle training (Other)
结局指标
主要结局
Visual analogue scale
时间窗: Baseline, week 8, 3-month after intervention, 6-month after intervention
Self-rated pain intensity of knee (0-100), "0" indicate no pain, "100" indicate worst pain.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index(Baseline, week 8, 3-month after intervention, 6-month after intervention)
- Serum levels of inflammatory markers(Baseline, up to week 8)
- Heart rate variability(Baseline, up to week 8)
- 40-meter walk test(Baseline, up to week 8)
- 30-sec chair stand test(Baseline, up to week 8)
- Pittsburgh Sleep Quality Index(Baseline, week 8, 3-month after intervention, 6-month after intervention)
- Maximal inspiratory pressure(Baseline, up to week 8)
- Prefrontal cortex activity(Baseline, up to week 8)
- Physical Activity Scales for the Elderly(Baseline, week 8, 3-month after intervention, 6-month after intervention)
- 12-Item Short Form Health Survey(Baseline, week 8, 3-month after intervention, 6-month after intervention)
- The Knee injury and Osteoarthritis Outcome Score(Baseline, week 8, 3-month after intervention, 6-month after intervention)
研究者
SU Shan
Dr.
The Hong Kong Polytechnic University