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临床试验/NCT05127603
NCT05127603已完成不适用

The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain: A Mixed-Method Multiple Case Study

Rotterdam University of Applied Sciences1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Change in qualitative outcomes on illness perceptions, coping, self-perceived health condition and evaluating treatment: two semi-structured interviews will be conducted

研究概览

简要总结

The aim of this study is to explore and evaluate the effects of an individually tailored intervention focusing on influencing dysfunctional illness perceptions and dysfunctional movement/pain behavior in patients with non-specific neck pain.

详细描述

Introduction:

Worldwide, neck pain is the 3th most common disorder that interferes with people's daily functioning. Many people with neck pain consult a physical therapist because of their pain, however treatment effects are small. Recent studies in a broader group of people with musculoskeletal pain show that physical therapy interventions tailored to individual risk profiles for chronicity are more effective. Considering the importance of psychological prognostic factors in neck pain it is hypothesized that influencing dysfunctional cognitions and negative emotions affects the way people cope with their pain and therefore can influence their self-perceived health condition in a positive way.

Research questions:

  1. How does an individually tailored intervention that focuses on influencing dysfunctional illness perceptions and dysfunctional movement/ pain behavior change people's illness perceptions, the way they cope with their pain, their self-perceived health condition and to what do these people attribute this change?
  2. Do changes in specific illness perceptions (i.e. cognitions and emotions measured by the IPQ-k and FABQ-pa) mediate the effect of an individually tailored physiotherapy cognitive behavioral intervention measured by the Global Perceived Effect, Self-efficacy (PSEQ), Functioning (PSFS) and Pain (NPRS).

Design:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Neck pain with no signs of major pathology, but with interference on daily activities (i.e., neck pain Grade II
  • •Aged 18-65
  • •The neck pain is present for a minimum of 2 weeks and pain and/or disability continues or increases
  • •A minimum score of 4 on the Start Neck Tool
  • •Good command of the Dutch language

排除标准

  • •Neck pain with neurological signs (i.e., neck pain Grade III) or neck pain with signs of serious pathology (i.e., neck pain Grade IV)
  • •Psychiatric disorders
  • •Surgery in the neck-arm area (< 3 months) and/or an acute mechanical trauma (< 3 weeks) in history

研究组 & 干预措施

Individually tailored physiotherapy; cognitive behavioral intervention

Experimental

The intervention is offered in accordance with the Neck Pain Guidelines, with a focus on influencing dysfunctional illness perceptions and dysfunctional movement/ pain behavior.

干预措施: Cognitive behavioral intervention (Behavioral)

结局指标

主要结局

Change in qualitative outcomes on illness perceptions, coping, self-perceived health condition and evaluating treatment: two semi-structured interviews will be conducted

时间窗: Change in illness perceptions, coping and health condition from week 1 (i.e. mid-baseline, one week before the start of the intervention phase) till a week after the end of the intervention (i.e. week 9 or 10)

An exploration of changes in (1) illness perceptions, (2) how people cope with their neck pain, (3) their perceived health condition and (4) to what they attribute a change in their perceived health condition during individually tailored physiotherapy treatment

Change in Global Perceived Effect Scale (GPES) (7-points Likert scale) (Quantitative outcome measurement)

时间窗: Immediately after the first treatment consultation (week 3) and the second (week 4), third (week 5), fourth (week 6) and the fifth (+sixth/seventh) consultation (week 7 (+8/9) and at 3 months after the last consultation (i.e. follow up week 19/21)

The GPES is a self-administered measure used to investigate the participant's perception of effect from the intervention they received. The GPES is scored on a seven-level Likert scale (1=Very much improved, 2=Much improved, 3=A little improved, 4=No change, 5=A little deterioration, 6=Much deterioration, 7=Very much deterioration)

次要结局

  • Average Pain Intensity (assessed by the Numeric Pain Rating Scale (NPRS))(Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation)
  • Pain Self-Efficacy (assessed by the Pain Self-Efficacy Questionnaire (PSEQ-2 / PSEQ-4))(Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation (regardless of whether this was the 5th, 6th or 7th consultation))
  • Functional Disability (assessed by the Patient Specific Functional Scale (PSFS))(Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation)

研究者

发起方
Rotterdam University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maaike Kragting

Principal Investigator, PhD-student, Physical Therapist and Lecturer

Rotterdam University of Applied Sciences

研究点 (1)

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