跳至主要内容
临床试验/NCT02996955
NCT02996955已完成不适用

Influence of Social Support and Treatment of Illness Perceptions on Patient's Adherence to a Physical Activity Advice

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016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
入组人数
240
试验地点
1
主要终点
adherence to the activity advice

研究概览

简要总结

Low back pain is worldwide a common musculoskeletal condition with a high number of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a next episode could be prolonged by advising an active lifestyle. Advising regular physical activity is the mainstay in physical therapy treatment. This includes an appeal to patients to adhere to an activity advice. Patient adherence to an activity advice is poor. In this study an intervention consisting of treatment of illness perceptions with or without organizing social support to increase adherence to an activity advice will be investigated.

The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence .

This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years presenting with at least a second episode of non-specific low back pain.

Patients in the intervention and control group will be asked to perform a physical activity advice. During two physiotherapy treatment sessions treatment of illness perceptions is performed in both groups. In the intervention group organizing social support by a partner or friend is added.

Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the intervention group is clinically relevant.

During four appointments several questionnaires have to be filled in and during two physiotherapy treatment sessions half an hour treatment of illness perceptions will be performed. Social support by a partner or friend will be organized during the same physiotherapy treatment sessions in the intervention group. During three separate weeks patients have to wear an activity monitor. Patients will be treated according to the Dutch Low Back Pain guideline; no adverse effects will be expected.

详细描述

Objective of the study:

The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, 2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence to an activity advice.

Study design:

This study is a multicentre randomized two arm, controlled clinical trial. During a twelve-week intervention period, one group of patients will receive an activity advice added to usual treatment including 'treatment of illness perceptions' (C-group). The other group will receive an activity advice and the intervention addressing social support by a partner or friend added to usual treatment including 'treatment of illness perceptions' (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks. Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12 centres for physiotherapy in the province Zuid-Holland, the Netherlands.

Study population:

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Non-specific low back pain

排除标准

  • •Patients physical active in accordance with the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007)
  • •Patients with specific low back pain
  • •Onset of the low back pain after age 50 years,
  • •Continuous pain regardless of posture or movement,
  • •Nocturnal pain,
  • •General malaise,
  • •History of malignancy,
  • •Unexplained weight loss,
  • •Elevated erythrocyte sedimentation rate (ESR)
  • •Previous vertebral fracture,
  • •Older person with hip fracture,
  • •Prolonged use of corticosteroids,
  • •Onset of low back pain before age 20 years,
  • •Iridocyclitis,
  • •History of unexplained peripheral arthritis or inflammatory bowel disease,

研究组 & 干预措施

SoSup group

Experimental

usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8

干预措施: social support (Behavioral)

SoSup group

Experimental

usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8

干预措施: treatment of illness perceptions (Behavioral)

SoSup group

Experimental

usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8

干预措施: Activ8 (Device)

SoSup group

Experimental

usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8

干预措施: activity advice (Other)

C group

Active Comparator

usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8

干预措施: treatment of illness perceptions (Behavioral)

C group

Active Comparator

usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8

干预措施: Activ8 (Device)

C group

Active Comparator

usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8

干预措施: activity advice (Other)

结局指标

主要结局

adherence to the activity advice

时间窗: 12 weeks

proportion of patients (non)adhering to the activity advice measured by the Activ8

次要结局

  • changes in patient's illness perceptions(base line, one week, 6 and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验