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

NCT ID: NCT06446141

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-05-31

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 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.

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 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.

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,.

Conditions

Thoracic Outlet Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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 Type: EXPERIMENTAL

Osteopathic technique

Intervention Type: OTHER

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

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,.

Group Type: ACTIVE_COMPARATOR

Osteopathic technique

Intervention Type: OTHER

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.

Interventions

Osteopathic technique

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeezy S. Eraky, Lecturer

Role: STUDY_CHAIR

Department of Physical Therapy for Internal Medicine and Elderly

Ehab A. Abdallah, Lecturer

Role: STUDY_CHAIR

Department of Orthopedic Physical Therapy

Haitham M. Elmasry, Lecturer

Role: STUDY_CHAIR

Department of Basic science

Hatem M. El-Samouly, Asst Prof

Role: STUDY_CHAIR

faculty of medicine

Locations

Horus University

Damietta, International Coastal Road New Damietta, Egypt

Countries

Egypt

Other Identifiers

HorusU1

Identifier Type: -

Identifier Source: org_study_id