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Completed
NCT05917756
Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome
Conditions: Thoracic Outlet Syndrome
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Ahram Canadian University
Location: Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Governorate
Summary
This study will investigate whether adding Mobilization With Movement (MWM) to a standardized rehabilitation program improves arm, shoulder, and hand function in adults with chronic neurogenic thoracic outlet syndrome (nTOS), compared with a sham manual procedure added to the same rehabilitation program.
A total of 120 participants aged 18-65 years will be randomly assigned to two equally sized groups. One group will receive MWM plus standardized rehabilitation, and the other will receive sham MWM plus the same rehabilitation program. The sham procedure will reproduce therapist contact, positioning, treatment time, and attention without the specific manual technique used in active MWM. Both groups will receive 16 supervised sessions over 8 weeks, with two 45-minute sessions per week, and the same home-exercise program.
The main outcome will be upper-extremity disability measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks. Additional outcomes will include pain intensity, disability at other assessment times, health-related quality of life, patient-perceived improvement, cervical range of motion, and adverse events. Scheduled assessments will take place before treatment and at 4, 8, and 12 weeks after randomization, with patient-perceived change assessed at Weeks 8 and 12.
Participants and outcome assessors will be masked to active versus sham manual treatment. The study hypothesis is that MWM added to standardized rehabilitation will produce greater improvement in upper-extremity disability than sham MWM added to the same rehabilitation program.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18-65 years.
* Symptoms consistent with neurogenic thoracic outlet syndrome (nTOS) for at least 3 months.
* Diagnosis of nTOS confirmed by a physician experienced in thoracic outlet disorders using prespecified consensus-based clinical criteria, including compatible local thoracic outlet findings, peripheral upper-extremity symptoms suggesting brachial plexus irritation, and the absence of another diagnosis that better explains the presentation.
* Symptoms consistent with nTOS that are reproduced or aggravated by relevant upper-extremity positions or sustained or repetitive activities, where applicable.
* Ability to understand study procedures, provide written informed consent, and participate in the rehabilitation program and outcome assessments.
Exclusion Criteria:
* Previous surgery for thoracic outlet syndrome.
* Clinical evidence of arterial or venous thoracic outlet syndrome.
* Acute or progressive vascular symptoms requiring medical or surgical evaluation.
* Significant intrinsic hand-muscle atrophy or progressive objective motor weakness requiring specialist surgical assessment.
* Cervical radiculopathy or myelopathy judged to be the principal cause of the participant's symptoms.
* Clinically significant peripheral entrapment neuropathy, major shoulder pathology, brachial plexopathy, or another neurological or musculoskeletal condition judged to be the principal cause of upper-extremity symptoms.
* Previous major cervical or shoulder surgery likely to substantially affect upper-quarter biomechanics or outcome assessment.
* Contraindications to manual therapy or therapeutic exercise.
* Concurrent structured physiotherapy or manual therapy specifically directed at nTOS during the 8-week intervention period.
Source: ClinicalTrials.gov (NCT05917756). StuddyBuddy aggregates publicly available trial information.