Evaluation of Different Exercise Trainings Applied in Patients With Chronic Pain From Exercise Adherence, Clinical and Economic Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 519
- 试验地点
- 1
- 主要终点
- Assessment of Exercise Adherence and Patient Satisfaction
研究概览
简要总结
This study was conducted with 519 patients in order to examine the clinical and cost-effectiveness of different exercise trainings in patients with chronic pain and the adherence of the patients to the exercises given. The patients were divided into 3 groups as home-based exercise groups, physiotherapist-led groups and home-based follow up groups, and traditional physical therapy was applied for a total of 10 sessions. The patients were offered exercises in the form of a brochure to the home-based exercise groups, applied to the exercise group under the guidance of a physiotherapist, and to the home-based follow up groups in a way that reminded them of the exercises by sending a daily text message (SMS) after they were given exercise training accompanied by a physiotherapist. They were told to continue their exercises after the treatment. All groups were evaluated in terms of economic, clinical, quality of life, exercise adherence, and satisfaction three times: before the treatment, after the treatment, and three months after the treatment. Cost utility analysis (QALY) and cost-effectiveness ratio (ICER) were used as part of the economic evaluation. Oswestry Disability Index (ODI) and Neck Disability Index (NDI) were used for clinical evaluation. Quality of life was assessed with the EuroQol General Quality of Life Scale (EQ-5D-5L). A scale consisting of 5 (five) questions prepared by us was used for adherence with the exercise. In the evaluation of satisfaction, individuals were asked to give a score between 0-100. All three groups were called to the hospital for control three months later, and the 5-question scale prepared by us was directed to the patients and it was determined how the given exercises were done.
详细描述
This study was conducted to examine the clinical and cost-effectiveness of different exercise trainings in patients with chronic pain and the adherence of the patients to the exercises given. As a result of the findings obtained, it was carried out in order to contribute to the literature, to make suggestions to the decision makers and to determine the applicability of the exercise training given by the patients. 519 patients who were admitted to the Department of Physical Medicine and Rehabilitation T.C. Ministry of Health Kilis Prof. Dr. Alaeddin Yavaşca State Hospital with a complaint of low back and neck pain were included in the study. This study was carried out at Hasan Kalyoncu University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Patients were randomized by closed envelope randomization method as home-based exercise groups, physiotherapist-led groups, and home-based follow up groups, respectively.
The study protocol was approved by Hasan Kalyoncu University Ethical Committee (No: 2021/063, 03.05.2021). Informed consent was obtained from all of the patients.
Inclusion criteria for the study;
- 40 years and older
- Continuing low back or neck pain for 3 months or longer
- Mini mental test score more than 24 points
- Being able to speak Turkish
- Being able to be contacted via phone
- The patients participating in the study do not receive any other physiotherapy, Exclusion criteria for the study;
- Patients diagnosed with serious pathologies that may be the main cause of chronic low back pain (presence of lumbar stenosis, spondylolisthesis, fibromyalgia, etc.)
- Patients with a history of spinal surgery
- Patients for whom physiotherapy is contraindicated
Our study was planned as a prospective, randomized controlled study. The patients were pre-assessed by the physiotherapist to determine their suitability for the inclusion criteria. The first patient, whose suitability was determined, was allowed to choose his group using the closed envelope technique, and the following patients were randomized as Group-1 (home-based exercise groups), Group-2 (physiotherapist-led groups), Group-3 (home-based follow up groups).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years and older
- •Continuing low back or neck pain for 3 months or longer
- •Mini mental test score more than 24 points
- •Being able to speak Turkish
- •Being able to be contacted via phone
- •The patients participating in the study do not receive any other physiotherapy,
排除标准
- •Patients diagnosed with serious pathologies that may be the main cause of chronic low back pain (presence of lumbar stenosis, spondylolisthesis, fibromyalgia, etc.)
- •Patients with a history of spinal surgery
- •Patients for whom physiotherapy is contraindicated
研究组 & 干预措施
home-based exercise groups
home exercise brochures were given to the home-based exercise groups according to their diagnosis at the end of the treatment. Then, all patients were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 (five) questions was directed to the patients and it was determined how the exercises given were performed. Five different exercises were given to patients with low back and neck pain who participated in our study. The patients were asked to do these exercises 3 times a day for 10 repetitions. Cat-camel exercises, lumbar stretching, sit-ups, bridge building and back extensor strengthening exercises were given to patients with low back pain. For patients with neck pain, neck flexion-extension, neck lateral flexion, neck rotation, shoulder capsule stretching and shoulder flexion exercises were given.
physiotherapists-led groups
The group involved in physiotherapists-led groups was shown the exercises in practice and under the supervision of the physiotherapist, the patients applied their exercises throughout their treatment. Then, all patients were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 (five) questions was directed to the patients and it was determined how the exercises given were performed. Five different exercises were given to patients with low back and neck pain who participated in our study. The patients were asked to do these exercises 3 times a day for 10 repetitions. Cat-camel exercises, lumbar stretching, sit-ups, bridge building and back extensor strengthening exercises were given to patients with low back pain. For patients with neck pain, neck flexion-extension, neck lateral flexion, neck rotation, shoulder capsule stretching and shoulder flexion exercises were given.
干预措施: physiotherapist-led groups, home-based follow up groups (Procedure)
home-based follow up groups
Home-based follow up groups, after the exercise training was given to the patients with a physiotherapist, daily text messages (SMS) were sent to the patients and the patients were reminded to do the exercises. Then, all patients were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 (five) questions was directed to the patients and it was determined how the exercises given were performed. Five different exercises were given to patients with low back and neck pain who participated in our study. The patients were asked to do these exercises 3 times a day for 10 repetitions. Cat-camel exercises, lumbar stretching, sit-ups, bridge building and back extensor strengthening exercises were given to patients with low back pain. For patients with neck pain, neck flexion-extension, neck lateral flexion, neck rotation, shoulder capsule stretching and shoulder flexion exercises were given.
干预措施: physiotherapist-led groups, home-based follow up groups (Procedure)
结局指标
主要结局
Assessment of Exercise Adherence and Patient Satisfaction
时间窗: 3 months
The scale consisting of a total of 5 (five) questions prepared by us three months after the treatment for exercise adherence was directed to the patients. With these questions, the patients' adherence with the exercises given to the patients was asked, the control of whether the given exercises were done correctly was as follows: "0: forgotten, 1: unable to do, 2: correct position but wrong movement, 3: correct position and movement, no respiratory control, and 4: absolutely doing". was evaluated. It was accepted that the patients who scored 3 and 4 points from the exercises remembered the exercises.
Economic Evaluation
时间窗: 3 months
Within the scope of the economic evaluation, cost-utility and cost-effectiveness analyzes of the treatments were made. The cost-utility analysis was calculated from the perspective of the Social Security Institution (SGK) as the ratio of the total payment to the QALY (quality adjusted life years) value. For the cost-effectiveness analysis, it was calculated with the incremental cost-effectiveness ratio (ICER). In terms of the home-based follow up groups, the cost was calculated separately by adding the fees spent for home-based follow up groups purposes in addition to the SGK package fee. The Turkish version of the EQ-5D-5L scale was used to calculate the QALY value. The QALY value was calculated by evaluating the results with Germany score weights. The reason for using Germany point weights is that there is no point weights for our country and Germany point weights are used in cost effectiveness analysis studies.
Oswestry Disability Index
时间窗: 3 months
The Oswestry Disability Index is a widely used scale that measures the functional status of individuals. This scale was first described in 1980 by Fairbank et al. (122). In this scale, which consists of 10 questions in total, each question is between 0-5 points and the highest result that can be obtained from the scale is 50 points. The total score is multiplied by 2 and expressed as a percentage. The Turkish validity and reliability study of the scale, which shows that disability increases as the score obtained from the scale increases, was conducted by Yakut et al. (123).
Neck Disability Index
时间窗: 3 months
The Neck Disability Index is a widely used scale that measures the disability level of individuals related to neck pain. This scale was defined by Vernon and Mior in 1991 (124). Neck Disability Index; It consists of 10 sections that include pain intensity, personal care, lifting, reading, headaches, concentration, work/work, driving, sleep and leisure activities. Each question consists of 6 answer options that measure the severity of pain or limitation. Scoring is done between 0-5. The highest score is 50 and the minimum score can be 0. According to the total score; 0-4: no limitation, 5-14: mild limitation, 15-24: moderate limitation, 25-34: severe limitation, 34 and above: fully restricted (124). The Turkish validity and reliability study of the scale was performed by Telci et al. (125).
Assesment of Quality of Life
时间窗: 3 months
EQ-5D identifier system; It consists of 5 parts: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each part has 5 options: no problem, mild problem, moderate problem, serious problem and extreme problem. The patient is asked to indicate the state of health by ticking the box next to the most appropriate statement in each of the five sections. This decision results in a 1-digit number for that part. The digits of the five parts can be combined into a five-digit number describing the patient's state of health. The 5-digit number obtained from the scale is calculated using Microsoft Excel over the formulas calculated by the EuroQoL group. The answers received from these patients are placed in the program and personal values between 0 and 1 are calculated. According to this score, a value of 0 indicates death and a value of 1 indicates excellent health.
次要结局
未报告次要终点
研究者
Irfan Kucukoglu
PhD Student
Hasan Kalyoncu University