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临床试验/NCT07281183
NCT07281183
已完成
不适用

The Effects Of Reformer Pilates And Manual Therapy On Pain, Kinesiophobia, Range Of Motion, Quality Of Life, Muscle Strength, Muscle Flexibility And Muscle Shortness In Women With Chronic Low Back Pain

Uskudar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月28日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Uskudar University
入组人数
40
试验地点
1
主要终点
Change in Pain Intensity (Visual Analog Scale)

概览

简要总结

The purpose of this study is to compare the effects of manual therapy alone and manual therapy combined with Reformer Pilates exercises in women with chronic low back pain (CLBP).

详细描述

The aim of this study was to compare the effects of manual techniques alone and manual techniques combined with Reformer Pilates exercises in women with chronic low back pain (CLBP), focusing on pain, kinesiophobia, range of motion (ROM), muscle strength, trunk endurance, functional level, and quality of life.

A total of 40 women with CLBP who applied to the Kayroterapi Exercise Center were included. Participants were randomized by odd and even numbers into two groups. The control group (MTG) received a manual techniques protocol once a week for 50 minutes over 8 weeks, while the experimental group (MTRPG) received the same protocol in addition to two 50-minute Reformer Pilates sessions per week. Sociodemographic data were collected through a questionnaire specifically designed for the study. Pain was assessed using the Visual Analog Scale (VAS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), and functional disability with the Functional Low Back Pain Scale and the Oswestry Disability Index. Muscle strength was evaluated using manual muscle testing, ROM with a goniometer, and trunk endurance with the sit-and-reach test.

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
Female
接受健康志愿者

入选标准

  • Age between 25 and 55 years
  • Female gender
  • Voluntary participation in the study
  • History of low back pain lasting longer than 12 weeks and diagnosis of mechanical low back pain (chronic low back pain)
  • No contraindications to exercise
  • No physical or mental condition preventing participation in the study

排除标准

  • Age below 5 years or above 55 years
  • Low back pain lasting less than 12 weeks
  • Presence of chronic comorbid disease (e.g., hypertension, diabetes, or other systemic conditions)
  • Regular use of medication
  • Presence of a neurological pathology
  • Any contraindication to exercise
  • Inability to establish verbal or visual communication
  • Pregnancy

结局指标

主要结局

Change in Pain Intensity (Visual Analog Scale)

时间窗: 4 months

The Visual Analog Scale (VAS), used to assess pain intensity, is a simple, reliable, and easily applicable method. This scale consists of a standard 10 cm vertical or horizontal straight line, with one end indicating "no pain" (0) and the other end indicating "the most severe pain" (10). The patient is asked to mark a point on the line that best represents their current level of pain. The score is then determined based on the location of the mark. Studies have reported that the VAS is a reliable tool for measuring pain intensity.

Oswestry Disability Index: ODI

时间窗: 4 months

This scale, which is widely used to assess the level of functional disability in individuals with low back pain, evaluates daily living activities. It consists of a total of 10 subcategories: pain intensity, degree of pain variation, personal care, lifting, sitting, standing, sleeping, social life, traveling, and sexual activity. Each section contains six statements scored from 0 to 5. The individual is asked to choose the statement that best describes their current condition. The total score ranges from 0 to 50. The interpretation of scores is as follows: 1-10 points: Mild functional disability 11-30 points: Moderate functional disability 31-50 points: Severe functional disability The Turkish validity and reliability study of the scale was conducted by Yakut et al.

Back Pain Functional Scale : FBAS

时间窗: 4 months

This scale is used to assess the extent to which individuals' functional levels are affected by low back pain. The functional areas included in the scale are as follows: work, school, home activities, hobbies, forward bending, putting on shoes or socks, lifting objects from the floor, sleeping, sitting, standing, walking, climbing stairs, and driving. For individuals who do not drive, the last item is answered as "traveling." Each item is scored between 0 and 5. According to the scoring system: (0): Unable to perform the activity 1. : Extremely difficult 2. : Very difficult 3. : Moderately difficult 4. : Slightly difficult 5. : Not difficult The total score ranges from 0 to 60. A score of 60 indicates that the individual can perform all activities without any difficulty.

Sit and Reach Test : SRT

时间窗: 4 months

It is a simple and widely used physical assessment test designed to evaluate an individual's level of flexibility. During the test, the individual sits on the floor with both legs extended straight and the soles of the feet placed against a box. A 26 cm ruler is placed on top of the box prepared for the measurement. The participant is asked to reach forward as far as possible without bending the knees. The farthest point reached is held for approximately 2 seconds, and the distance is recorded. The best result from two trials is taken and recorded in centimeters.

Range of Motion : ROM

时间窗: 4 months

Goniometric measurement is an objective method used in clinical settings to assess normal joint range of motion. During the measurement, the patient is positioned comfortably and appropriately for the joint being evaluated. Before beginning the assessment, the procedure is explained to the patient. All joints are aligned according to the anatomical position, and measurements are taken based on the zero starting position. Joint movements are generally assessed within a range of motion from 0° to 180°. Normal range of motion values for the upper and lower extremities and the vertebral column may vary depending on the reference source. In clinical practice, the most commonly used reference standards are those published by Kendall and the American Academy of Orthopaedic Surgeons (AAOS).

Manual Muscle Testing : MMT

时间窗: 4 months

It is a clinical method used to assess muscle strength. The basis of these tests was developed by Dr. Robert W. Lovett, Professor of Orthopedics at Harvard Medical School, and was first applied in 1912. The evaluation is scored between 0 and 5 based on the muscle's performance against gravity. The interpretation of these scores may vary depending on the specific muscle being tested. 5 (Normal): The muscle completes full range of motion against gravity and maximal external resistance. 4 (Good): The muscle completes full range of motion against gravity but with less than maximal resistance. 3 (Fair): The muscle completes full range of motion against gravity but without any added resistance. 2 (Poor): The muscle completes full range of motion in a gravity-eliminated position. 1 (Trace): Muscle contraction is palpable, but no joint movement occurs. 0 (Zero): No muscle contraction is felt or observed.

次要结局

未报告次要终点

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Öğr. Üyesi Muhammed Fatih Kavak

Assistant Professor

Uskudar University

研究点 (1)

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