Back to resultsMobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome
Primary Purpose
Thoracic Outlet Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program
Conventional Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Outlet Syndrome
Eligibility 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
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A (experimental group)
Group B (control group)
Arm Description
MWM techniques combined with a tailored therapeutic exercise program
Conventional physiotherapy combined with a tailored therapeutic exercise program
Outcomes
Primary Outcome Measures
Changes in Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).
Secondary Outcome Measures
Changes in Functional Status
Functional status will be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Changes in Cervical Range of Motion
Cervical range of motion will be assessed using a goniometer.
Changes in Quality of Life
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917756
Brief Title
Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Outlet Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm randomized controlled trial with an equal allocation ratio (1:1) for the experimental and control groups
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (experimental group)
Arm Type
Experimental
Arm Description
MWM techniques combined with a tailored therapeutic exercise program
Arm Title
Group B (control group)
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy combined with a tailored therapeutic exercise program
Intervention Type
Other
Intervention Name(s)
Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in Pain Intensity
Description
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).
Time Frame
Changes in Pain intensity at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Changes in Functional Status
Description
Functional status will be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Time Frame
Changes in Functional Status Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Title
Changes in Cervical Range of Motion
Description
Cervical range of motion will be assessed using a goniometer.
Time Frame
Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Title
Changes in Quality of Life
Description
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome
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