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

NCT06446141 | Completed

• 1 other identifier: HorusU1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Outlet Syndrome

Keywords

Osteopathic Technique - Respiratory Parameters - Pain

Outcome Measures

Primary Outcomes (3)

• (a) A portable spirometer:

  (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).

  3 month

• (b) Micro Respiratory Pressure Meter:

  (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)

  3 month

• (c) Visual Analogue Scale:

  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).

  3 month

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: Osteopathic technique

Group B

ACTIVE COMPARATOR

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,.

Other: Osteopathic technique

Interventions

Osteopathic technique 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 A; Group B

Eligibility Criteria

• Age: 30 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Horus University

Damietta, International Coastal Road New Damietta, 17611, Egypt

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zeezy S. Eraky, Lecturer

  Department of Physical Therapy for Internal Medicine and Elderly

  STUDY CHAIR

• Ehab A. Abdallah, Lecturer

  Department of Orthopedic Physical Therapy

  STUDY CHAIR

• Haitham M. Elmasry, Lecturer

  Department of Basic science

  STUDY CHAIR

• Hatem M. El-Samouly, Asst Prof

  faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Physical Therapy for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Horus University, New Damietta, Egypt

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: May 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

EG (1)