跳至主要内容
临床试验/NCT06446141
NCT06446141已完成不适用

Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome

Horus University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月1日最近更新:
适应症

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
2
主要终点
(a) A portable spirometer:

研究概览

简要总结

Background: With regard to patients with thoracic outlet syndrome (GBS), it is important to improve inspiratory muscle strength and endurance, and pain perception in patients with TOS, so that patients are able to regain pulmonary function and endurance. Objective: To investigate the impact of osteopathic interventions on respiratory parameters and pain levels in individuals diagnosed with thoracic outlet syndrome (TOS). Subjects and methods: forty adults after the onset of TOS will be assigned randomly into two equal groups. In Group A will be allocated to traditional physical therapy program, three sessions/week in addition to 60-minute sessions of Osteopathic technique, one session/week for 3 months, group B will receive traditional physical therapy program, three sessions/week for 3 months. Selected respiratory parameters by spirometer, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) and a visual analogue scale of pain severity, measured at baseline and after 3 months.

详细描述

Method Design This parallel, two-group, randomized controlled trial will use concealed allocation, blinding of outcome assessors and intention-to- treat analysis. People with TOS will enroll to 3-month, osteopathic technique (Group A) or traditional physical therapy program (Group B). The allocation order will be concealed by placing each random allocation in a sealed opaque envelope, which will be opened after the participant enrolled in the study. Thus, researchers and therapists will not know or decide which enrolling participant would receive which therapy. After an envelope was opened, the participant and the therapists who administered the interventions will became aware of that participant's allocated intervention. Outcomes were measured at baseline and after 3 months. In addition to ethics approval ***********************.

Participants The study was conducted in Outpatient clinics of Faculty of physical therapy, Horus University. The study population will be consisted of patients diagnosed, by physicians or neurologists, as previous cases of 'definite' TOS. To be eligible to participate, patients with TOS were required to be aged 30-35 years, be in a stable clinical condition and have a physical disability based on assessment. The exclusion criteria were Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.

Measurement procedures:

  1. Spirometer:
  2. Micro Respiratory Pressure Meter:
  3. Visual Analogue Scale:

Interventions Group A In addition to usual care from the treating physician or neurologist, participants will be prescribed a 3 months program. It will consist a 60 minute of traditional physical therapy program, three sessions/week in addition to 60-minute of Osteopathic technique, once per week.

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 (Participant)

盲法说明

I- Postural correction through correction of:

  • Forward head
  • Protracted shoulders
  • Depressed shoulder.

II- Strengthen ex to:

  • Shoulder girdle elevators and retractors.
  • Cervical and dorsal extensors
  • raising arms to reach full flexion and elevation.

III- Restoration of normal mobility

o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat& slow, sustain and self-stretching ex.

IV- Breathing ex: diaphragmatic breathing.

入排标准

年龄范围
30 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The study population consisted of patients diagnosed, by physicians or neurologists, as previous cases of 'definite' TOS.
  • To be eligible to participate, patients with TOS were required to be aged 30-35 years, be in a stable clinical condition and have a physical disability based on assessment.

排除标准

  • Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.

结局指标

主要结局

(a) A portable spirometer:

时间窗: 3 month

(MIR Spirolab®) was used to measure pulmonary function test; forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1), and Tiffeneau index (Forced expiratory volume in the one second/Forced vital capacity) (FEV1/FVC).

(c) Visual Analogue Scale:

时间窗: 3 month

This scale was utilized to measure the pain intensity before and after treatment. The pain test was 10 cm (100 mm) length with two endpoints labeled (0=no pain) and (10=most pain ever).

(b) Micro Respiratory Pressure Meter:

时间窗: 3 month

(MicroRPMTM made in USA). It was a handheld manometer with a disposal mouth-piece and used to calculate maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

次要结局

未报告次要终点

研究者

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

Ahmed Metwally Mohamed Elshinnawy

Assistant Professor, Department of Physical Therapy for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Horus University, New Damietta, Egypt

Horus University

研究点 (2)

Loading locations...

相似试验