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临床试验/NCT06895057
NCT06895057已完成不适用

Comparison of the Effects of Telerehabilitation and Clinic-Applied Core Stabilization Exercises on Pain, Quality of Life and Endurance in Patients With Chronic Low Back Pain

Gaziantep Islam Science and Technology University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年3月20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
32
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. In this way, the effect of low-cost, easy-to-access and longer-term telerehabilitation in the treatment of chronic low back pain will be examined comparatively with face-to-face application.

详细描述

Low back pain is a common health problem worldwide, characterized by the persistence of its symptoms. It usually occurs as a musculoskeletal injury that can occur at work, during exercise, after a traumatic event, or from a condition of unknown cause. According to the National Institutes of Health, 80% of adults experience low back pain in their lifetime. Data from the 2015 National Health Interview Survey showed that the population with low back pain is over 140 million annually. Nonspecific low back pain is a type of pain where the cause cannot be specifically determined, such as tumors, spinal fractures, or infections. According to its duration, low back pain is classified as: acute pain (lasting less than 6 weeks); subacute pain (lasting between 6 weeks and 3 months); or chronic pain (lasting longer than 3 months).

There are various methods for the treatment of chronic low back pain. The aim of the treatment methods is to reduce pain, increase functionality and prevent deterioration in daily life activities. There is strong evidence in treatment-oriented studies that exercise training reduces pain and improves quality of life. The core region is responsible for the transfer of power between the upper and lower extremities of the body. All movements start from the core region and are transferred to the extremities. It is also the most important muscle group that provides body stabilization. The stability of the spine is negatively affected in people with low back pain. Generally, individuals with pain problems have poorly coordinated muscles around the spine and weakness in the core region. Core stabilization exercises aim to improve the strength and control of the muscles that are central to maintaining spinal stability. Telerehabilitation is an online or offline tool that allows personalized treatment of patients. It also allows patients to access information about their treatment and condition at any time. This reduces costs and geographical barriers. The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. In this way, the effect of low-cost, easy-to-access and longer-term telerehabilitation in the treatment of chronic low back pain will be examined comparatively with face-to-face application.

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
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •People with chronic back pain between the ages of 25-55
  • •People with back pain for more than 3 months
  • •Ability to read and understand Turkish
  • •Volunteer to participate in the study
  • •Those with pain intensity above 3 on the Visual Analog Scale (VAS)

排除标准

  • •Not accepting to participate in the study,
  • •Having any pathology that causes back pain (e.g. infections, tumors or rheumatoid arthritis)
  • •Having liver, heart, lung, kidney failure or tumor
  • •Having a history of cerebrovascular disease
  • •Having a neurological disease or skeletal muscle degenerative disease
  • •Using assistive devices
  • •Having cognitive disorders
  • •Being pregnant
  • •Having undergone orthopedic surgery in the last two years
  • •Those with scoliosis

研究组 & 干预措施

telerehabilitation group

Experimental

The exercise program will be applied online via tablet.Individuals who will participate in the study will be put into practice twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face before and after the application for both groups. The treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be made face to face by the same therapist in the clinic, twice before and after the training.

The core stabilization exercise program to be applied is planned as follows.

  • Warm-up exercises (10 minutes) (Straight leg raise, circle drawing, side opening)
  • Finding neutral spine position (Pelvic Tilt)
  • Bridge exercise, (one leg pull-up in bridge, bridge rise, fixed hold)
  • Table (abdominal exercise)
  • Crawling position stretching exercises
  • Plank exercises (Advanced plank exercises such as fixed hold, side plank, single leg pull-up

干预措施: Exercise (Other)

clinical practice group

Experimental

The exercises will be applied face to face to the clinical practice group. Individuals who will participate in the study will be put into practice twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face before and after the application for both groups. The treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be made face to face by the same therapist in the clinic, twice before and after the training.

The core stabilization exercise program to be applied is planned as follows.

  • Warm-up exercises (10 minutes) (Straight leg raise, circle drawing, side opening)
  • Finding neutral spine position (Pelvic Tilt
  • Bridge exercise, (one leg pull-up in bridge, bridge rise, fixed hold)
  • Table (abdominal exercise)
  • Crawling position stretching exercises
  • Plank exercises (Advanced plank exercises such as fixed hold, side plank

干预措施: Exercise (Other)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: At Baseline and 8 weeks after the baseline

The Visual Analog Scale (VAS) will be used to digitize some data that cannot be measured numerically. VAS, developed by Max Freyd, is the most commonly used measurement method in the assessment of pain. The two extreme definitions of the parameter to be evaluated are written on the scale at both ends of a 100-millimeter line, and the patient is asked to indicate by marking the appropriate place on this line for his/her own situation. The starting point of the scale represents no pain, and the ending point represents the most severe pain.

Quality of Life Scale Short Form (SF-36)

时间窗: At Baseline and 8 weeks after the baseline

This scale is one of the most common measures used to measure quality of life. It is a questionnaire that examines 8 parameters of health such as physical function, social function, mental health, vitality (energy), pain, role limitations (due to physical and emotional problems), and general perception of health with 36 items. The scale is a self-assessment scale. It can be completed in a short time. Instead of obtaining a single score at the end of the scale, each parameter has its own scoring. A score of 0 indicates poor health status, while 100 indicates good health status. Questions 3-12 are used for physical function, 13-16 for physical role difficulty, 17-19 for emotional role difficulty, 23,27,29,31 for energy, 24,25,26,28,30 for mental health, 20 and 32 for social functioning, 21-22 for pain, and 1 and 33-36 for general perception of health. Each item is scored mathematically according to the answer given within itself. For example, for emotional role difficulty, the transform

Mcgill Body Endurance Tests

时间窗: At Baseline and 8 weeks after the baseline

Trunk flexion test: Individuals will be positioned with the soles of their feet on the floor, with knees and hips at 90° flexion, trunk at 60° flexion, and hands crossed on both shoulders. All individuals will be asked to maintain this position and a chronometer will be used to measure at the same time. When the position is disrupted, the test will be terminated and the elapsed time will be recorded in seconds. Trunk extension test: Individuals will be assessed in the prone position. Individuals will be asked to hang from the bed starting from the spina iliaca anterior superior and arms will be crossed on both shoulders. The lower extremity will be fixed by the researcher and individuals will be asked to move their trunks backwards. Trunk lateral bridge test: Individuals will be evaluated on both the right and left sides. For the right side, individuals will be positioned on the forearm with the arm perpendicular to the body, with the elbow flexed at 90°, with the body facing forward.

Oswestry Scale

时间窗: At Baseline and 8 weeks after the baseline

The purpose of this index is to measure the functionality levels of individuals with low back pain. It evaluates the changes in parameters such as patients' lifting, pain intensity, personal care, sitting, walking, standing, traveling, social life, and sleeping when they are in pain. There are 6 propositions under each parameter. Patients choose the most appropriate proposition for them. In this way, a total score is obtained by obtaining a score between 0-5 from each question. A maximum of 50 points can be obtained as a result of the test. The score received by the patient is divided by the maximum score that can be obtained, which is 50, and the result obtained is multiplied by 100 to obtain the patient's score from the index.

Modified Schober Test

时间窗: At Baseline and 8 weeks after the baseline

It will be used to evaluate the flexibility of the individuals to be included in the study. Both posterior spina iliaca will be marked. 10 cm above and 5 cm below the marked area is determined, the individual is asked to bend forward, the difference between the initial value will be recorded in cm. This measurement will be made to the patient twice, at the beginning of the treatment and at the end of the treatment. A difference of 0-5 cm in the test indicates that flexion flexibility has decreased, while a difference of over 10 cm indicates that flexibility has increased. Values between 5-10 cm are considered normal.

Patient Global Indicator of Change (PGIC)

时间窗: 4 and 8 weeks after the baseline

It will be used as a scale of recovery and satisfaction in the 4th and 8th weeks of treatment. It is a 7-point scale that reflects the patient's evaluation of the effectiveness of the treatment. 1=No change, 2=Almost the same, 3=Slightly better, 4=Slightly better, 5=Moderately better, 6=Better, 7=Much better

次要结局

未报告次要终点

研究者

发起方
Gaziantep Islam Science and Technology University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zekiye Beyza Kolukısa

physiotherapist

Gaziantep Islam Science and Technology University

研究点 (1)

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