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临床试验/NCT02121587
NCT02121587已完成不适用

Stage 2 Delivery and Evaluation of an Integrated Osteopathy, Mindfulness and Acceptance-based Programme for Patients With Persistent Pain

University College of Osteopathy3 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
255
试验地点
3
主要终点
European Quality of Life Questionnaire (EQ5D)

研究概览

简要总结

The purpose of this pre and post intervention observational study is to evaluate patient-reported outcomes from an new clinical course which integrates Mindfulness and Acceptance-based approaches from '3rd wave' Cognitive Behavioural Therapy with osteopathic manual therapy treatment for patients with persistent pain.

It is being conducted by the British School of Osteopathy (BSO) in London. In Stage 1 (in progress, June 2013 to August 2014), a course was developed for self-referring patients attending the BSO Clinic. In Stage 2 (September 2014 to May 2016), delivery will be expanded to evaluate outcomes for patients attending National Health Service (NHS) General Practitioner (GP) surgeries in South East London.

The intervention consists of a pre-course screening interview; a structured course of six, weekly, one-hour treatment sessions for individual patients; and an optional follow-up interview after three months.

The evaluation study is being conducted by an independent study team from the National Council for Osteopathic Research. Patients complete a set of standardised questionnaires before the course and after six months to assess self-reported changes in quality of life, well-being, activity levels, mindfulness and use of health resources. A sample of patients will be invited to provide consent for a treatment session to be observed and/or recorded, or to attend a follow-up interview after six months, to evaluate the quality of course delivery. This is an observational study of patient-reported outcomes from a new intervention in a single cohort of patients, so there is no formal study hypothesis but it is anticipated that outcomes will include increased quality of life, well-being, and active engagement with valued activities.

详细描述

The OsteoMAP course is a new clinical intervention integrating Mindfulness and Acceptance-based approaches of Cognitive Behavioural Therapy with manual therapy for patients with persistent pain. In Stage 1 (in progress, June 2013 to April 2014) an intervention for individual patients of six, structured, one hour sessions was piloted by osteopaths at the British School of Osteopathy (BSO) in London with patients already attending the osteopathic clinic. In Stage 2 (awaiting ethical approval, September 2014 to May 2016) recruitment will be expanded to include NHS patients referred from, and treated in, participating GP practices in South East London. The study aims to assess whether participants report improved quality of life, well-being and engagement in personally-valued activities six months after their course ends.

Osteopathy is a low risk form of manual therapy that promotes physical functioning in the musculoskeletal system. Acceptance-based approaches promote a way of thinking that encourages acceptance of unwanted experiences (i.e. symptoms which cannot be fully resolved) by recognising that emotions, thoughts and physical sensations do not necessarily control behaviour. Chronic pain is an increasing healthcare burden with significant psychological, social and economic consequences but there is evidence that Mindfulness can be effective with a range of mental and physical health problems, including chronic pain.

This observational evaluation study includes a 'before-and-after' patient-reported outcome study with an embedded qualitative interview study and a fidelity evaluation. There is no control group or comparison with standard care. The programme was funded as a new service development, not primary research, but will generate new data from pre and post course measures using standardised self-report questionnaires at baseline and after six months. The fidelity assessment of adherence and competence will evaluate whether the course being delivered as intended, independently observed by a team from the National Council for Osteopathic Research (NCOR).

Recruitment: Posters will be placed in participating surgeries with information sheets for doctors who wish to discuss the OsteoMAP course with patients. Patients will be invited to 'opt in' by completing application forms and invited to Pre-Course Interviews to screen for eligibility and discuss the nature and potential benefits and risks of joining an experiential course. Patients will complete standardised questionnaires before their interview, either electronically on a laptop computer which submits data directly to the evaluation team via Survey Monkey, or as paper copies with stamped addressed envelopes.

Pre-Course interviews aim to explore patients' willingness to try a new approach to pain management and assess motivation and scope for change. Patients will be told about potential psychological risks, as they will be invited to think about the full impact of pain and to increase their awareness of both pleasant and painful experiences. Joint decisions will be made about whether it is appropriate for a patient to join. If it is not clear, the patient will be asked for permission to contact their doctor before a decision is made.

研究设计

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

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 the age of 18
  • Persistent musculoskeletal pain for more than six months duration
  • Known medical diagnosis and stable condition
  • Pain or pain-related behaviour limits activity
  • Can identify scope for change
  • Motivated to participate in a six week, experiential self-management course
  • Suitable for osteopathic manual therapy
  • Able to provide informed consent
  • Sufficient spoken English to participate in consultations without an interpreter
  • Able to attend the selected clinic locations when appointments are available

排除标准

  • Do not conform to the inclusion criteria above
  • Active, uncontrolled alcohol or substance abuse
  • Active uncontrolled psychotic mental health problem
  • Undergoing or awaiting further diagnostic medical investigations
  • Currently attending a pain clinic or other psychological support service

结局指标

主要结局

European Quality of Life Questionnaire (EQ5D)

时间窗: Pre-course baseline at week 0 to 30 weeks

To assess changes in quality of life from before the start of the six week course to six months after the course ends.

次要结局

  • Activity Avoidance Questionnaire (AAQ-IIR) Questionnaire(Pre-course week 0 to week 30)
  • Freiburg Mindfulness Inventory for mindfulness skills(Pre-course week 0 to week 30)
  • Bournemouth Questionnaire for pain-related beliefs and behaviour(Pre-course week 0 to week 30)
  • Self-reported changes in health resource utilisation(Single measure at 30 weeks)

研究者

发起方
University College of Osteopathy
申办方类型
Other
责任方
Sponsor

研究点 (3)

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