Viewing Study NCT06446141



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06446141
Status: COMPLETED
Last Update Posted: 2024-06-06
First Post: 2024-06-01

Brief Title: Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome
Sponsor: Horus University
Organization: Horus University

Study Overview

Official Title: Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 sessionsweek in addition to 60-minute sessions of Osteopathic technique one sessionweek for 3 months group B will receive traditional physical therapy program three sessionsweek 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
Detailed Description: 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 participants 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 andor 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 sessionsweek in addition to 60-minute of Osteopathic technique once per week

The program included

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

The Osteopathic technique included

Patients will be positioned in a supine position Osteopathic technique will consist of supoccibital release soft tissue release of thoracic outlet mobilization of cervical facet joints stretching of scalene anterior scalene medius upper trapezius and levator scapula pectorals major and minor Subsequently cost vertebral and cost transverse joint mobilizations will be applied using rib elevation Then manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique Afterwards mobilization of the first rib will be applied Finally mobilization of the upper cervical spine will be performed

Group B In addition to usual care from the treating physician or neurologist participants were prescribed a 60 minute three times per week of traditional physical therapy program

The program included

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None