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临床试验/NCT03132064
NCT03132064暂停不适用

The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement

University of Salford1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
50
试验地点
1
主要终点
Changes in Pain Catastrophizing Scale (PCS)

研究概览

简要总结

To explore whether there are factors that help us to understand why some patient outcomes are not successful and identify prediction factors for progression. Assess central pain sensitisation and psychology pre- and post-surgery with reliable tools that explore prediction tools for good/poor progression and improve patient selection, patient preparation and timing for surgery.

The aim of this project is to explore the effects of pre-surgical central pain sensitisation on pain and function outcomes post-TKA. Central pain sensitisation will be assessed using pressure algometry and the Pain Catastrophizing Scale will be used to explore pain psychology. Functional outcomes post-TKA will be assessed using a commonly used scale for patients' self-reported outcomes (Oxford Knee Score), visual analogue scale, a star excursion balance test and four recommended patient performance-based tests.

详细描述

Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most common chronic condition in primary care in the UK. By 2030 it is predicted to be the greatest cause of disability in the general population. An effective end-stage treatment for knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.

In England and Wales, the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data analysis by the National Joint Registry and the Office of National Statistics suggests that, by 2030, primary TKAs will increase by 117% from the 2012 level. Subsequently, TKA revision surgeries are expected to increase incrementally by 332%. There is a similar estimation of demand for revision TKA surgeries in the United States; by 2030, they are expected to rise by 601% from the 2005 level. The United States estimation of primary TKA is for growth of 673% from the 2005 level, which is similar to England and Wales's upper-limit projections.

Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied . Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. the presence of surgical complications or implant survival. This is gradually changing to involve the patient in measuring health outcomes and decision-making processes. Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes.

Worldwide National Joint Registry summarise the common indication for TKA revision are; 29.8% due to aseptic loosening, 14.8% infection and 9.5% due to pain. Most prediction studies show that pain and psychology pre-operation may predict poor outcomes post-TKA. A systematic review by concludes that pain catastrophizing predicts chronic pain post-TKA. Pain catastrophizing is defined as a construct that reflects anxious preoccupation with pain, an inability to inhibit pain-related fears, amplification of the significance of pain vis-à-vis health implications, and a sense of helplessness regarding pain.

Chronic post-surgery pain is significantly associated with preoperational central sensitisation as in post-shoulder subacrominal decompression and hernia repair. Regarding post-TKA, a study by Lundblad et al. (2008) concluded that the preoperational hand electrical pain threshold significantly predicts pain outcomes one year post-TKA. The study explored the association between chronic pain post-TKA and preoperation widespread pain sensitisation using pressure algometry. Both study association without control the psychological confiding factor. The correlation with Western Ontario and McMaster Universities Osteoarthritis Index pain score (WOMAC) is questionable due to weakness of WOMAC with post TKA population such as low sensitivity of WOMAC's stiffness subscale reduces the overall standardized response mean and high ceiling effect Psychological pain thinking is assessed using the most widely used measuring scale: Pain Catastrophizing Scale (PCS). PCS assesses pain thinking in three dimensions: rumination ("I can't stop thinking about how much it hurts"), magnification ("I worry that something serious may happen") and helplessness ("It's awful and I feel that it overwhelms me").

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients scheduled for elective primary unilateral total knee arthroplasty for end-stage knee osteoarthritis with stable and controlled medical condition

排除标准

  • Potential research participants were excluded from the study if ;
  • The patients schedule for bilateral knee arthroplasty or unilateral knee revision surgery.
  • The patient cannot read and understand English language.
  • Their function limited due to other musculoskeletal involvements other than unilateral knee osteoarthritis.
  • Diagnosed with uncontrolled diabetes mellitus or blood pressure.
  • Diagnosed with any neurologic disorders such as stroke, Parkinson disease or multiple sclerosis.
  • morbid obese patients their body mass index BMI greater than
  • Advance osteoporosis or other unstable chronic disease.
  • Diagnosed with peripheral vascular diseases or uncontrolled cardiac diseases.
  • The participant will excluded post-surgery if they develop any surgical complication such as deep vein thrombosis, uncontrolled infection, or fracture

结局指标

主要结局

Changes in Pain Catastrophizing Scale (PCS)

时间窗: before surgery and 6 months after

Catastrophizing contributes to heightened levels of pain, emotional distress, chronic pain and disability (Forsythe, Dunbar, Hennigar, Sullivan, \& Gross, 2008). The PCS has 13 items and can be completed and scored in less than 5 minutes. It reflects past painful experiences and indicates the degree to which patients experience each of 13 thoughts or feelings when in pain. It has 5-point scales with end points (0) not at all and (4) all the time. Between the 50th and 75th percentiles of PCS score, patients are considered at moderate risk and at more than the 75th percentile they are consider at high risk for developing chronicity. It is a reliable and valid catastrophizing measure, it shows excellent internal consistency, total score coefficient alphas = .87-.93 and significant correlation with the Inventory of Negative Thoughts in Response to Pain scale and general psychological disturbance (MASQGeneral Disturbance) scale (Osman et al., 1997; Sullivan \& et al., 1995) (Appendix 3).

Changes in Central Sensitisation using pressure algometry

时间窗: before surgery and 6 months after

Pressure will be applied using a handheld pressure algometer (Algometer Type II, Somedic AB, Sweden) at a rate of 30 kPa/s perpendicular to the skin with a 1 cm² probe. The pressure pain threshold will be estimated by instructing participants to say 'stop' when the sensation of pressure becomes the first sensation of pain (Arendt-Nielsen et al., 2010; Lunn, Kristensen, Gaarn-Larsen, \& Kehlet, 2012; Skou et al., 2013). Pressure will be applied to the medial side of the operated knee and the volar surface of the same side forearm. These two body sites are chosen because they represent painful areas in knee OA patients and may provide evidence of widespread pain sensitisation (forearm) and localised pain sensitisation (knee) (Wylde, Palmer, Learmonth, \& Dieppe, 2011; Wylde et al., 2013). The site for knee pressure will be at 3 cm medial to the midpoint on the medial edge of the index patella

次要结局

  • Changes in Oxford Knee Score (OKS)(before surgery and 6 months after)
  • Changes in pain visual analogue scale (VAS);(before surgery and 6 months after)
  • Changes in Assessment of Performance based measurements (30 s chair-stand test)(before surgery and 6 months after)
  • Changes in stair-climb test(before surgery and 6 months after)
  • Changes in Timed up-and-go test(before surgery and 6 months after)
  • Changes in Six minute walk test(before surgery and 6 months after)
  • Changes in Balance Test(before surgery and 6 months after)
  • Changes in Physical activity(before surgery and 6 months after)

研究者

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

Bodor Bin sheeha

Principal Investigator -PhD student at University of Salford

University of Salford

研究点 (1)

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