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临床试验/NCT05623683
NCT05623683已完成不适用

Pain Profiles and Patterns of Physical Activity in Persons With Chronic Knee Pain

Northwestern University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Change from pre-walking to immediately post-walking in Numeric Pain Rating Scale (NPRS) for current knee pain

研究概览

简要总结

The goal of this single-blind, cross-over clinical trial is to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (OA). In this cross-over trial, participants will perform two types of walking on a treadmill. Intermittent walking will involve 3 blocks of 10 minutes with 2 blocks of 5-minute rest (sitting on a chair) in-between. Continuous walking will involve resting for 10 minutes (sitting in a chair) before walking on the treadmill for 1 continuous block of 30 minutes.

详细描述

The study objectives are to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (OA). The investigators hypothesize that continuous walking will result in greater increases in clinical pain and mechanistic pain sensitivity than intermittent walking. Physical activity (PA) has been recommended as the first-line management strategy for people with chronic knee pain. Walking is an accessible, low-cost, joint-friendly form of PA and is widely advocated for older adults with knee complaints. However, movement-evoked pain is a commonly cited barrier for PA engagement. On one hand, a bout of PA may produce short-term analgesia and reduce pain. On the other hand, excessive or prolonged PA may exacerbate symptoms and lead to avoidance/fear of subsequent PA. Besides the total PA volume, how it is accumulated could also impact joint health. It is biomechanically plausible that shorter and frequent activities are more beneficial to articular tissues than longer and infrequent activities. Compared to intermittent loading, prolonged continuous loading had a detrimental effect on the biomechanical functions of articular cartilage in a bovine model. Findings of this study will provide insight on the relations between patterns of PA and pain profiles.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

To blind the participants, they will be told that both walking interventions are equally likely to cause a decrease, no change, or an increase in knee pain, and we will compare potential differences between the two walking interventions.

To blind the outcome assessor, the assessor will assess outcomes in a different place from the place where the intervention takes place.

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men or women aged 45-75 years
  • BMI ≤ 35 kg/m2
  • frequent movement-related knee pain (knee pain on more than half the days of the past month)
  • no morning stiffness or morning stiffness lasting < 30-min
  • self-reported unilateral or bilateral knee pain of ≥ 3 and ≤ 7 on a 0-10 numeric pain rating scale (NPRS)
  • knee pain duration ≥ 12 months
  • physically able to walk unassisted on a treadmill at ≥ 4 km/hour for 30 minutes
  • own a smart phone
  • willing and able to wear an activity monitor and answer electronic survey questions delivered via a smart phone over a 10-day period.

排除标准

  • intra-articular steroid injections in the previous 3 months
  • intra-articular hyaluronic acid injection in the previous 6 months
  • any arthroscopic or surgical knee procedures (e.g., partial meniscectomy) in the past 12 months
  • lumbar radiculopathy
  • neurological, vestibular, or visual dysfunction affecting walking balance and mobility
  • plan for total knee arthroplasty in the next 12 months

结局指标

主要结局

Change from pre-walking to immediately post-walking in Numeric Pain Rating Scale (NPRS) for current knee pain

时间窗: pre-walking, immediately post-walking

The primary outcome is the self-reported clinical pain. The pre- and post-walking knee pain will be rated right before the commencement of the walking program and at the termination of the walking program respectively. Participants verbally select a value that corresponds with the intensity of pain that they experience. "0" means "no pain" and "10" means "pain as bad as you can imagine" or "worst pain imaginable". The NPRS, an 11-point (i.e., 0-10) measure of pain intensity, is recommended as a core outcome measure in clinical trials of chronic pain treatments and has excellent reliability and validity for adults with chronic musculoskeletal pain. On average, a change of 2 points or a change of approximately 30% in NPRS represented a clinically important difference in adults with chronic pain.

次要结局

  • Change from pre-walking to immediately post-walking in Cuff Pain Detection Threshold (cPDT)(pre-walking, immediately post-walking)
  • Change from pre-walking to immediately post-walking in Cuff Pain Tolerance Threshold (cPTT)(pre-walking, immediately post-walking)
  • Change from pre-walking to immediately post-walking in Temporal Summation of Pain (TSP)(pre-walking, immediately post-walking)
  • Change from pre-walking to immediately post-walking in Conditioned Pain Modulation (CPM)(pre-walking, immediately post-walking)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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