Effectiveness of ENBORTH-TR Intervention on Pain, Quality of Life, Sleep Quality, Kinesiophobia, Perceived Occupational Performance and Satisfaction in Low Back and/or Neck Pain: A Single Blind Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
This study was conducted to investigate the effectiveness of the ENBORTH-TR training programme given in addition to client-centred intervention in individuals with low back and/or neck pain. The current study investigates the effect of ENBORTH-TR on pain, quality of life, sleep quality, kinesiophobia and perceived occupational performance and satisfaction levels. This study was designed according to the CONSORT statement, which provides standardisation in randomised controlled trials. In addition, the study was approved by the scientific research ethics committee of a university. Written informed consent was obtained from all participants before the study.
详细描述
This study was planned as a single-blind randomized controlled trial and was conducted using the CONSORT checklist. Participants who met the inclusion and exclusion criteria and signed the written consent form were divided into 2 groups by simple randomization. While the client-centered intervention procedure was applied to both groups within the scope of the study, the ENBORTH-TR intervention procedure was also applied to the intervention group. All intervention procedures in the study were planned with the telerehabilitation method for 3 days a week for 4 weeks and each session was planned to consist of 45-minute sessions. A total of 136 people were included in the study, 69 in the control group and 67 in the intervention group.
Interventions Client-centered intervention procedure
Using the literature, a client-centered intervention procedure for individuals with low back and/or neck pain was developed. This intervention procedure consists of 5 steps. These steps are as follows:
First phase: Setting measurable, realistic and achievable goals to address occupational performance issues
Second phase: Developing and evaluating the pros and cons of possible solutions by brainstorming on the oupations identified by the Canadian Occupational Performance Measure.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be at least primary school graduate
- •Participating in the study voluntarily
- •To be able to read and write Turkish
- •At least 24 points from the Mini Mental State Examination
- •Having low back and neck pain for 3 months or more
- •Being between the ages of 18-65
排除标准
- •Having a neurological, psychiatric or chronic disease (cancer, etc.) or having any secondary disease that will adversely affect the work
- •History of any malignancy or spinal fracture
- •Having undergone a surgical procedure for low back and/or neck pain or having undergone any other surgical intervention within the last 6 months
- •Not participating regularly in the intervention process
- •Participating in another rehabilitation program during the study period
- •Diagnosis of pregnancy or suspected pregnancy
研究组 & 干预措施
Control Group
According to the evaluation results, client-centred occupational therapy intervention was applied to this group. The client-centred occupational therapy intervention is based on the activities that the participants stated in the COPM in the first evaluation and had problems.
干预措施: Client-centred Occupational Therapy Intervention Group (Behavioral)
ENBORTH-TR Invertention Group
In this study, ENBORTH-TR training programme is applied in addition to person-centred intervention. ENBORTH-TR programme starts from the definition of pain, explains its mechanism, affected muscle groups, and provides awareness training that will improve the quality of life of individuals in pain management such as environmental regulations, relaxation techniques, stress management.
干预措施: ENBORTH-TR Intervention (Behavioral)
ENBORTH-TR Invertention Group
In this study, ENBORTH-TR training programme is applied in addition to person-centred intervention. ENBORTH-TR programme starts from the definition of pain, explains its mechanism, affected muscle groups, and provides awareness training that will improve the quality of life of individuals in pain management such as environmental regulations, relaxation techniques, stress management.
干预措施: Client-centred Occupational Therapy Intervention Group (Behavioral)
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: 30 minutes
COPM, which is most frequently used among occupational therapists, is a standardised measurement tool used to determine the individual's activity performance problems and to measure performance satisfaction. In the COPM, which is a semi-structured interview, individuals evaluate their activity preferences with performance and satisfaction scores given by themselves. Individuals are asked about their activity performance problems and concerns about 3 areas including self-care, productivity and leisure time activities. Up to three problems can be identified in each activity area (self-care, productivity, leisure). Performance and satisfaction scores are again determined by the individual between 1 and 10 points.
Visual Analog Scale (VAS)
时间窗: 5 minutes
Visual analogue scale was used to assess the pain intensity of the participants. During the assessment, the participants were asked to mark the points where they felt pain during sleep, rest and activity on a 10 cm horizontal line with the left end 0 meaning 'no pain' and the right end 10 meaning 'very severe pain'. Before marking, the individuals were explained in detail what they should do. Then, the distance of the marked points to point 0 was measured and recorded in centimetres
Tampa Scale of Kinesiophobia (TSK)
时间窗: 7 minutes
The TSK, which is used in the evaluation of kinesiophobia, is a Likert-type scale consisting of 17 questions. Each question is scored between 1 and 4 points (1 = strongly disagree to 4 = strongly agree). The lowest score that can be obtained from the scale is 17 and the highest score is 68. A high score in the total score of the scale indicates a high level of kinesiophobia.
Nottingham Health Profile (NHP)
时间窗: 10 minutes
The NHP used to assess the people's QoL consists of a total of 38 questions. It has 6 subscales and assesses energy, pain, emotional reactions, sleep, social isolation and physical activity. Scoring is done between 0 and 100, with a high score indicating a low QoL.
次要结局
- The Pittsburgh Sleep Quality Index (PSQI)(15 minutes)
研究者
Berkan Torpil, PhD
Assoc Prof
Saglik Bilimleri Universitesi