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临床试验/NCT07749248
NCT07749248已完成不适用

The Impact of Physiotherapy on Pulmonary Function Tests and Psychosocial Well-Being in Patients With Thoracic Discopathy : A Randomized Controlled Trial

Medipol University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11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
40
试验地点
1
主要终点
Change in Forced Expiratory Volume in 1 Second (FEV1)

研究概览

简要总结

Background and Objective:

Information regarding the effects of physiotherapy on quality of life and alterations in pulmonary function tests among patients with thoracic discopathy is notably limited in the literature. This study aims to compare the effects of the classical physiotherapy approach and the addition of breathing exercises to classical physiotherapy on quality of life and respiratory function tests in patients with thoracic discopathy.

Study Design and Methods:

This controlled and randomized study includes 40 patients diagnosed with thoracic discopathy. Participants are divided into two groups. The first group undergoes 15 sessions of classical physiotherapy consisting of ultrasound, TENS, hot packs, and posture exercises. The second group receives the same classical physiotherapy program with the addition of respiratory exercises. The patients' disability, psychosocial well-being, and pulmonary function are assessed using standardized scales and questionnaires at baseline (pre-treatment) and after the 15-session intervention (post-treatment).

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)

盲法说明

The study was designed as single-blinded; the researcher responsible for conducting the pre- and post-treatment clinical questionnaires and pulmonary assessments was blinded to the patients' group allocation to minimize detection bias.

入排标准

年龄范围
25 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of thoracic discopathy
  • Planned to receive physiotherapy as part of their treatment

排除标准

  • Participants with pre-existing respiratory system abnormalities
  • Participants with a disease affecting the rib cage

研究组 & 干预措施

Only Physiotherapy

Active Comparator

Patients in this group underwent 15 sessions of traditional physiotherapy consisting of ultrasound, TENS, hot packs, and posture exercises.

干预措施: Traditional Physiotherapy (Other)

Physiotherapy and Breathing Exercise

Experimental

Patients in this group participated in a breathing exercise program in addition to undergoing the same 15 sessions of traditional physiotherapy procedures (ultrasound, TENS, hot packs, and posture exercises).

干预措施: Traditional Physiotherapy (Other)

Physiotherapy and Breathing Exercise

Experimental

Patients in this group participated in a breathing exercise program in addition to undergoing the same 15 sessions of traditional physiotherapy procedures (ultrasound, TENS, hot packs, and posture exercises).

干预措施: Breathing Exercise (Other)

结局指标

主要结局

Change in Forced Expiratory Volume in 1 Second (FEV1)

时间窗: Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program.

FEV1 measures the volume of air forcefully exhaled in the first second of a forced exhalation, assessed via spirometry. The unit of measure is Liters (L). A higher value indicates better pulmonary function.

Change in 36-Item Short Form Survey (SF-36) Physical Functioning Score

时间窗: Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program

The SF-36 questionnaire assesses health-related quality of life. The physical functioning subscale evaluates limitations in performing physical activities. The score ranges from 0 to 100. Higher scores represent better physical functioning and a higher quality of life.

Change in Resting Pain Intensity assessed by Visual Analog Scale (VAS)

时间窗: Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program.

Pain intensity at rest is evaluated using a visual analog scale. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents the "worst imaginable pain". A lower score indicates a reduction in pain intensity and clinical improvement.

Change in FEV1/FVC Ratio Percentage

时间窗: Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program.

The ratio of Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity (FVC), expressed as a percentage (%). This is measured via spirometry to assess airflow limitation. A higher percentage generally indicates better respiratory capacity.

次要结局

未报告次要终点

研究者

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

Çağlayan Aslanbaş

Asst. Prof. Dr.

Medipol University

研究点 (1)

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