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Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome

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ClinicalTrials.gov Identifier: NCT05917756
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : June 26, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy ElMeligie, Ahram Canadian University

Study Description
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Brief Summary:
This randomized controlled trial aims to evaluate the effects of Mobilization with Movement (MWM) on pain, function, and quality of life in patients with Thoracic Outlet Syndrome (TOS) compared to conventional physiotherapy.

Condition or disease Intervention/treatment Phase
Thoracic Outlet Syndrome Other: Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program Other: Conventional Physiotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm randomized controlled trial with an equal allocation ratio (1:1) for the experimental and control groups
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome: A Randomized Controlled Trial
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A (experimental group)
MWM techniques combined with a tailored therapeutic exercise program
 Other: Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program
The intervention consists of MWM techniques targeting the cervical and thoracic spine, and the first rib, applied by a certified physiotherapist for 8 weeks, 2 sessions per week, each session lasting 45 minutes. The intervention also includes a tailored therapeutic exercise program for the patients, comprising postural correction, stretching, and strengthening exercises. This intervention will be compared to conventional physiotherapy in the control group.
Active Comparator: Group B (control group)
Conventional physiotherapy combined with a tailored therapeutic exercise program
 Other: Conventional Physiotherapy
Conventional physiotherapy, including manual therapy (soft tissue mobilization, joint mobilization, and nerve gliding techniques) for 8 weeks, 2 sessions per week, each session lasting 45 minutes, combined with a tailored therapeutic exercise program (including postural correction, stretching, and strengthening exercises).


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Pain Intensity [ Time Frame: Changes in Pain intensity at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up) ]
    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).


Secondary Outcome Measures :
  1. Changes in Functional Status [ Time Frame: Changes in Functional Status Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up) ]
    Functional status will be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

  2. Changes in Cervical Range of Motion [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up) ]
    Cervical range of motion will be assessed using a goniometer.

  3. Changes in Quality of Life [ Time Frame: Changes in quality of life at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)aseline, 4 weeks, 8 weeks, and 12 weeks (follow-up) ]
    Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18-65 years, diagnosed with TOS by a specialist, and experiencing symptoms for at least 3 months

Exclusion Criteria:

  • Previous surgery for TOS
  • contraindications to manual therapy
  • other comorbidities significantly affecting upper limb function
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05917756


Contacts
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Contact: Mohamed M ElMeligie, Ph.d +201064442032 mohamed.elmeligie@acu.edu.eg

Locations
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Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University Recruiting
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
Contact: Mohamed M ElMeligie, Ph.d    01064442032    mohamed.elmeligie@acu.edu.eg   
Sponsors and Collaborators
Ahram Canadian University
Investigators
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Study Director: Amal Fawzy, Ph.d Faculty of Physical Therapy, Ahram Canadian University
More Information
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Responsible Party: Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier: NCT05917756    
Other Study ID Numbers: 012/0333666
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: June 26, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thoracic Outlet Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases