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Completed

NCT Number: NCT06446141

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

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.

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Key information

Age range

30 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Horus University

Damietta, International Coastal Road New Damietta, 17611, Egypt

About this study

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:

  • Spirometer:
  • Micro Respiratory Pressure Meter:
  • 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,.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. (a) A portable spirometer:

    Time frame: 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).

  2. (b) Micro Respiratory Pressure Meter:

    Time frame: 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)

  3. (c) Visual Analogue Scale:

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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