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临床试验/NCT07821047
NCT07821047尚未招募不适用

What Are the Associations Between Sleep and Pain in Osteoarthritis?

University of Reading0 个研究点目标入组 73 人开始时间: 2026年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
73
主要终点
Perceived sleep quality

研究概览

简要总结

People with osteoarthritis and painful joints often report poor sleep, but poor sleep can also increase pain. There have been very few studies of sleep in osteoarthritis using physical measuring devices, but in other painful conditions many people report worse sleep in questionnaires than actual sleep measured using wristwatch devices called actigraphs. This is called sleep misperception. Sleep misperception may affect the amount of pain that people report. Sleep misperception could be influenced by negative factors such as pain catastrophising (a tendency to ruminate on pain and its consequences), but also positive factors such as resilience and optimism. People who do not sleep well also have increased levels of "inflammation" in their blood (C-Reactive Protein, or CRP) and reduced pain thresholds for example to pressure or heat when tested in the laboratory. The aims of this study are to compare questionnaire and actigraphy measures of sleep in people with hip and knee osteoarthritis to see if there is sleep misperception. It is anticipated that people who report worse subjective compared to objective sleep will report more pain and have higher pain catastrophising as well as lower pain thresholds and less positive personality characteristics such as resilience. Participants will be asked to complete questionnaires about pain and sleep, mood and resilience, and to wear a wrist sleep monitoring device continuously for 7 days and nights and a brief daily sleep, pain and mood questionnaire. Willing participants will be asked to provide a pinprick of blood to measure CRP (inflammation), and Quantitative Sensory Testing (QST) for pressure pain and thermal pain thresholds using a blunt nylon filament and a heat probe on one forearm. Information from this study will be used to inform the development of a psychological intervention designed to improve resilience, sleep reporting and potentially pain.

详细描述

Osteoarthritis is the most common type of arthritis, most often affecting the hips and knees. Apart from pain and disability, many people with osteoarthritis anecdotally report sleep disturbances. The prevalence of self-reported sleep problems in osteoarthritis varies widely ranging from 11.9% (Gore et al., 2011) to 81% (Wilcox et al., 2000), however, these figures have not been supported by studies using objective sleep measures. While the relationship between sleep and pain is bidirectional (Frohnhofen, 2018), there is increasing evidence that sleep disturbance may impact pain, more than pain impacts sleep (Finan et al., 2013). In addition, patients with hip osteoarthritis believe that if they have better subjective sleep, their pain will improve (Blagestad et al., 2016). Sleep quality before hip and knee joint replacement is also one of the most crucial factors determining both immediate and longer-term post-operative pain (Bjurström et al., 2021; Boye Larsen et al., 2021).

There are theoretical reasons to explain why poor sleep could affect pain in osteoarthritis. Fragmented sleep may activate immune and inflammatory pathways which can increase central pain processing, as well as via an effect on mood (Smith et al., 2009). Meta-analyses have shown that sleep deprivation increases pain sensitivity in healthy controls (Schrimpf et al., 2015), and both short sleep duration and insomnia are causally linked to the development of chronic widespread pain (Williams et al., 2024). In osteoarthritis, participants with both pain and insomnia have increased central sensitisation on Quantitative Sensory Testing compared to controls (Campbell et al., 2015). Emerging evidence suggests that chronotype, an individual preference for "morningness" or "eveningness" may influence sleep quality, with "morning" types reporting better sleep quality (Yazdi et al., 2014). In addition, "evening" types may be more susceptible to musculoskeletal pain (Zhang et al., 2018), although the mechanisms for this are unclear. Qualitatively, patients with osteoarthritis describe difficulty getting to sleep, due to pain and positioning problems, as well as frequent waking during the night and difficulty getting back to sleep (Whale & Rachael, 2022). Self-reports of poor sleep in osteoarthritis are also associated with an increased level of pain catastrophizing (Campbell et al., 2015), a tendency to constantly think about pain and the negative consequences of pain (Quartana et al., 2009). A meta-analysis of plasma C-Reactive Protein (CRP) levels, a protein produced by the liver in response to the presence of inflammatory cytokines that is involved in immune activation and a biomarker for a peripheral inflammatory state, has shown a modest but significant increase in people with osteoarthritis (Jin et al., 2015). Experimental sleep deprivation is associated with higher levels of plasma CRP (Irwin et al., 2016) and cross-sectional population studies show that both shorter and longer than average sleep duration is associated with higher levels of plasma CRP (Lee et al., 2020; Zhang et al., 2023).

Potentially, as objective sleep data is time consuming and expensive to collect, most sleep studies in osteoarthritis favour subjective, self-report measures of sleep quality, such as the Pittsburgh Sleep Quality Index (PSQI) 1989) and the Insomnia Severity Index (ISI). Quantitative objective measurements, such as actigraphy or polysomnography (PSG) are much less commonly used and are typically used for only a few days. In two of the very few PSG studies of sleep in osteoarthritis, one showed more sleep-stage transitions suggestive of sleep fragmentation in people with osteoarthritis compared to controls (Yeung et al., 2018), another showed more light than deep sleep, implying worse sleep quality in people with osteoarthritis compared to controls (Leigh et al., 1988), although this study is limited by a sole recruitment of male participants. Whether this would replicate in a mixed sample remains an empirical question. In many sleep studies, it is common to find a disparity between subjective and objective measures of sleep quality, in particular, worse self-reported sleep efficiency and total sleep time, compared to objective sleep measures (Bean et al., 2021; Heitkemper et al., 2005). This phenomenon is often called 'sleep misperception' (Hughes et al., 2018).

The extent of sleep misperception varies between different clinical populations and in one study, increasing pain levels, but not age, depression or dysfunctional sleep beliefs lead to the greatest difference between subjective and objective sleep measures, suggesting that pain can cause people to negatively interpret their sleep (Hughes et al., 2018). Sleep misperception has been reported in people with several different pain conditions including rheumatoid arthritis (Hirsch et al., 1994) but not so far in osteoarthritis. Due to a paucity of empirical literature, the mechanisms underlying sleep misperception are unclear. One theory is that people who underestimate their sleep may have more frequent brief nocturnal awakenings (Harvey & Tang, 2012), also suggested in a small objective study in osteoarthritis (Yeung et al., 2018).

Positive personality factors that may be protective of sleep or sleep misperception such as resilience or self-efficacy have not been widely studied. Resilience has been described as an important characteristic that can help individuals "bounce-back" from challenging situations allowing adaptation and personal growth and is considered important regarding outcomes related to chronic pain (Smith & Zautra, 2008). Sleep and resilience are positively correlated in healthy individuals (Arora et al., 2022) and people with knee osteoarthritis who have high levels of psychological resilience also have higher levels of self-rated health (Hsieh et al., 2023). Three personal characteristics have been considered key characteristics of increased pain resilience - optimism, pain acceptance, and purpose in life (Smith & Zautra, 2008). In addition, self-efficacy (Bandura, 1977) which in the context of health is a belief in one's abilities to control symptoms, as well as external factors such as emotional or social support are also likely influence recovery or "bounce-back" from setbacks. Optimists tend to report better subjective sleep (Lau et al., 2017), lower levels of clinical pain (Shanahan et al., 2021) and lower pain catastrophising scores (Hood et al., 2012). In osteoarthritis, optimism is associated with less clinical pain and less experimental pain sensitivity (Thompson et al., 2018). In addition, people with more optimistic traits tend to report better sleep quality and fewer insomnia symptoms than those with fewer optimistic traits, even if their objective sleep is impaired, demonstrating a favourable sleep misperception pattern (Hernandez et al., 2020). This suggests that optimism may be a protective factor against the negative impact of sleep misperception and subsequent pain. The broader concept of pain resilience related to sleep has yet to be investigated in clinical populations with osteoarthritis. Another factor that may contribute to sleep misperception in osteoarthritis could be pain catastrophising; a collection of negative cognitive and affective biases to pain associated with feelings of helplessness (Quartana et al., 2009). In people with osteoarthritis, sleep disturbance is associated with both pain catastrophising and the level of knee pain (Wang et al., 2023).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Adults over 18 years with hip or knee osteoarthritis or both, confirmed by clinical staff or self-report plus application of American College of Rheumatology (ACR) clinical criteria for osteoarthritis of the hip or knee at the time of screening.

排除标准

  • Cognitive impairment
  • Participants who have already had hip or knee joint replacement surgery
  • Cancer which is not in remission
  • Other forms of arthritis for example rheumatoid arthritis
  • Participants with a nociplastic pain condition, for example fibromyalgia, neuropathic pain, or spinal surgery.
  • Sleep-disordered breathing including participants with a known diagnosis of obstructive sleep apnoea, sleepwalking, or nightmare disorder.
  • A diagnosis, or symptoms consistent with restless legs syndrome
  • Serious medical or mental health conditions which have not been stable on the same medication for the past 3 months for example heart failure, COPD, diabetes, or psychosis.
  • Participants who have started a new medication or changed a dose of medication within the past 3 months that could impact pain or sleep for example betablockers or antidepressants.

结局指标

主要结局

Perceived sleep quality

时间窗: At recruitment

This will be measures using The Pittsburgh Sleep Quality Index (PSQI) which records perceived sleep quality over the past 4 weeks using 19 items recorded on a 4-point scale. Increasing scores indicate worsening sleep quality.

Severity of insomnia symptoms

时间窗: At recruitment

The Insomnia Severity Index (ISI) will be used to record the the severity of insomnia symptoms and the consequences of sleep problems over the past 2 weeks. This is a 7-item questionnaire rated on a 5-point scale with higher scores indicating increasing severity of insomnia symptoms.

Sleep duration (perceived)

时间窗: From the date of recruitment for up to 28 days after recruitment

Each morning for 7 mornings, participants will complete the Consensus AM sleep diary detailing their perceived sleep time in minutes. This number will be calculated by subtracting the time they woke up from the time they estimate that they went to sleep the night before.

Sleep duration (actigraphic)

时间窗: From the date of recruitment for up to 28 days.

Objective sleep duration in minutes will be recorded with a CamNTech MotionWatch 8 for 7 nights.

Sleep misperception (sleep duration)

时间窗: From recruitment for up to 28 days.

Sleep misperception will be quantified in terms of the difference between objective (actigraphic) and subjective (diary) sleep time in minutes. Sleep misperception will be correlated with the level of pain (WOMAC and daily VAS)

Sleep misperception (sleep efficiency)

时间窗: Between recruitment and up to 28 days for 7 mornings in total.

Sleep efficiency, expressed as a percentage will be calculated as the difference between perceived time in bed and time asleep in minutes as recorded by daily Consensus sleep diary, and Actigraphy.

Osteoarthritis pain over the past month

时间窗: At recruitment

A clinical measure of osteoarthritis pain over the past month will be recorded using the pain scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for osteoarthritis of the hip or knee, a 5-item questionnaire scored on a 4-point Likert scale. This will be correlated with the degree of sleep misperception

Osteoarthritis daily pain

时间窗: After recruitment for up to 28 days, each morning for 7 days total.

Daily pain will be measured using an 11-point numeric rating scale (NRS) Higher scores on these questionnaires mean higher levels of pain. Pain on an 11 point numerical rating scale. This will be correlated with the degree of sleep misperception.

次要结局

  • Pain catastrophising(At recruitment)
  • Dysfunctional beliefs about sleep(Up to 28 days after recruitment)
  • Chronotype(Up to 28 days after recruitment)
  • Sleep effort(At recruitment)
  • Pre-sleep cognitive and somatic arousal(After recruitment for up to 28 days. For 7 mornings in total after sleep monitoring.)
  • Daily mood(Between recruitment for up to 28 days, every morning after sleep monitoring for 7 mornings.)
  • Positive and negative emotions(At recruitment)
  • Symptoms of depression(At recruitment)
  • Symptoms of anxiety(At recruitment)
  • Arthritis self-efficacy(At recruitment)
  • Pain acceptance(At recruitment)
  • Pain resilience(At recruitment)
  • Optimism(At recruitment)
  • Meaning in life(At recruitment)
  • Emotional support(At recruitment)
  • Quantitative sensory testing(Up to 28 days after recruitment)
  • Plasma high sensitivity CRP(Up to 28 days after recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katie Barfoot

Associate Professor

University of Reading

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