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

The Impact of Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Other: Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program; Other: Conventional Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain Intensity	Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).	Changes in Pain intensity at Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Functional Status	Functional status will be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.	Changes in Functional Status Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Changes in Cervical Range of Motion	Cervical range of motion will be assessed using a goniometer.	Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)
Changes in Quality of Life	Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire	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)

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome
• Other Study ID Numbers: 012/0333666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No