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临床试验/NCT03784339
NCT03784339已完成不适用

Feasibility Study: Does a Designated Education Session Change Levels of Catastrophizing, Kinesiophobia and Pain Beliefs in Patients With Patellofemoral Pain?

Manchester Metropolitan University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年3月2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
24
试验地点
1
主要终点
Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)

研究概览

简要总结

Feasibility study: Does a designated education session change levels of catastrophizing, kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site feasibility Study Aim: Aims are to identify if a formal education session (intervention) improves patient outcomes and to assess if it is possible to test the intervention for efficacy in a larger study.

Outcome Measures: The primary outcome measure is the Knee Osteoarthritis Outcome Score-Patellofemoral) KOOS-PF. The original KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of Life (QOL). The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral osteoarthritis (OA), or who are at risk of developing patellofemoral pain or OA.

Secondary Outcome Measures are Pain Catastrophizing Scale and The Tampa Scale for Kinesiophobia.

Patients who are eligible for inclusion in the study will be identified from the Musculoskeletal Clinical Assessment Service (MCAS) by Band 6's and 7's and approved by a Band 8 Physiotherapist the South Liverpool Treatment Centre.

Intervention: The intervention will comprise a 1:1, 30 minute education session delivered by a specialist musculoskeletal physiotherapist with over ten years' experience who has an interest in patellofemoral pain.

The education session will be based on a schedule formed from the most recent research on patellofemoral pain PFP which considers psychosocial factors (Robertson et al 2017). Crepitus is a word used to describe any grinding, creaking, cracking, grating, crunching or popping that occurs when the patellofemoral joint moves (Robertson et al 2017). The psychological factors, specifically patients' beliefs about crepitus, avoiding crepitus and the influence of others will be discussed.

The intervention will be supported by the leaflet 'managing my patellofemoral pain' developed by Barton and Rathleff (2016) on the basis of international opinion from 21 international experts and subsequent review by 20 patients diagnosed with PFP to ensure clarity.

Duration: Within the time constraints of a Masters Degree, patients will be recruited over a four month period. There will be four months for follow up and a further four months for write up, total study duration 12 months.

详细描述

Design: A feasibility study to assess if a physiotherapy education session in addition to standard care improves patients scores regarding catastrophizing and kinesiophobia when measured by KOOS-PF, Pain Catastrophizing Scale and Tampa Scale

Objectives:

  1. To assess if providing a specific education session which reviews patients beliefs about crepitus, causes of pain, joint mechanics and purpose of exercise has an effect on catastrophizing and kinesiophobia.
  2. To identify if the study is feasible on a larger scale, which would allow the intervention to be assessed for efficacy. If a future study was able to demonstrate that the intervention was effective this would provide an additional evidence based intervention for use in clinical practice.

Recruitment: NHS patients diagnosed in a Musculoskeletal Clinical Assessment Service [MCAS] with patellofemoral pain at the South Liverpool Treatment Centre.

Inclusion criteria:

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-40
  • Be able to understand and converse in English
  • Clinical diagnosis of PFPS
  • Be able to attend for up-to 12 weeks of physiotherapy

排除标准

  • Patients who present with referred pain from the spine or hip, or have tibiofemoral pathology of any nature on the ipsilateral side.
  • A diagnosis of PFJ osteoarthritis as confirmed by X-Ray or MRI.

结局指标

主要结局

Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)

时间窗: 12 weeks following baseline visit

The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.

次要结局

  • Pain Catastrophizing Scale (PCS)(12 weeks following baseline visit)
  • Tampa Scale for Kinesiophobia (TSK)(12 weeks following baseline visit)

研究者

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

James Selfe, DSc

Professor of Health Professions

Manchester Metropolitan University

研究点 (1)

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