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

NCT05917756 | Unknown

• 1 other identifier: 012/0333666
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in Functional Status

  Changes in Functional Status Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)

• Changes in Cervical Range of Motion

  Baseline, 4 weeks, 8 weeks, and 12 weeks (follow-up)

• Changes in Quality of Life

  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)

Study Arms (2)

Group A (experimental group)

EXPERIMENTAL

MWM techniques combined with a tailored therapeutic exercise program

Other: Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program

Group B (control group)

ACTIVE COMPARATOR

Conventional physiotherapy combined with a tailored therapeutic exercise program

Other: Conventional Physiotherapy

Interventions

Mobilization with Movement (MWM) and Tailored Therapeutic Exercise Program OTHER

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.

Group A (experimental group)

Conventional Physiotherapy OTHER

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).

Group B (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous surgery for TOS
• contraindications to manual therapy
• other comorbidities significantly affecting upper limb function

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Movement

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Model Details: Two-arm randomized controlled trial with an equal allocation ratio (1:1) for the experimental and control groups

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)