Thoracic Outlet SyndromeNCT06446141
Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome
A study testing Osteopathic technique in people with Thoracic Outlet Syndrome, run by Horus University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 35 years
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Osteopathic technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Horus University
Damietta, International Coastal Road New Damietta, 17611
About this study
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.
Read the 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:
- 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,.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Osteopathic technique
- Keywords
- Osteopathic Technique - Respiratory Parameters - Pain
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic techniqueOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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,. Receives: Other: Osteopathic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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).
Measured: 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)
Measured: 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).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 May 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Metwally Mohamed Elshinnawy, Horus University
- Investigators
- Zeezy S. Eraky, Lecturer, Study chair, Department of Physical Therapy for Internal Medicine and ElderlyEhab A. Abdallah, Lecturer, Study chair, Department of Orthopedic Physical TherapyHaitham M. Elmasry, Lecturer, Study chair, Department of Basic scienceHatem M. El-Samouly, Asst Prof, Study chair, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446141
- Sponsor's protocol ID
- HorusU1
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All IPD will be shared through the corresponding author after acceptance of all authors
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT06446141
- Acronym / sponsor ID
- HorusU1
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Osteopathic Technique - Respiratory Parameters - Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Osteopathic techniqueThe 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 | Active comparator | Other: Osteopathic techniqueI- 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 may qualify
- Ages
- 30 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic techniquePatients 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 | Group A, Group B |
Primary outcome
(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).
(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)
(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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided. All IPD will be shared through the corresponding author after acceptance of all authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeezy S. Eraky, Lecturer study chair
Department of Physical Therapy for Internal Medicine and Elderly
Ehab A. Abdallah, Lecturer study chair
Department of Orthopedic Physical Therapy
Haitham M. Elmasry, Lecturer study chair
Department of Basic science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic technique in people with Thoracic Outlet Syndrome, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(a) A portable spirometer: (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.