Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06446141 |
| Other study ID # |
HorusU1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Horus University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 'deļ¬nite' 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,.
