Motivational Interviewing in Thoracic Outlet Syndrome

Официальное название

The Effect of Motivational Interviewing on Thoracic Outlet Syndrome Symptoms in Patients With Thoracic Outlet Syndrome

Обзор

The goal of this clinical trial is to learn if motivational interviewing (MI) works to improve symptoms in people with thoracic outlet syndrome (TOS). TOS is a condition that causes long-term pain, numbness, and weakness in the arm and shoulder area. The main questions it aims to answer are: * Does MI lower pain and improve arm function in people with TOS? * Does psychological resilience predict treatment outcomes in people with TOS? Researchers will compare participants who receive MI sessions plus a home exercise program to those who receive a home exercise program alone. Participants will be randomly assigned to one of the two groups. Participants will: * Follow a home exercise program for 6 weeks * Some participants will also attend up to 4 motivational interviewing sessions * Complete questionnaires about pain, function, sleep, anxiety, and depression at the start and end of the 6-week program

Подробное описание

This is a single-center, non-blinded (assessor-blinded), parallel-group study examining the effect of motivational interviewing (MI) as an adjunct to a standardized home exercise program in patients with thoracic outlet syndrome (TOS). Eligible participants are randomly assigned using block randomization (block size of 4) to either the experimental arm (home exercise plus MI) or the active comparator arm (home exercise alone). The randomization sequence is generated using an online randomization tool by an individual not otherwise involved in the study, ensuring allocation concealment.

MI sessions are structured around four core techniques: open-ended questioning, affirmations, reflective listening, and summarizing. Sessions proceed through engagement, agenda setting, evocation of change talk, and goal setting phases, using strategies such as exploring ambivalence, decisional balance exercises, and scaling questions to assess motivation and confidence for behavior change. Homework assignments tailored to each participant's goals may include relaxation exercises, breath awareness training, and emotion regulation strategies in addition to the standard home exercise program.

All outcome assessments are conducted by a physiotherapist who is blinded to group allocation and not otherwise involved in delivering the interventions. Assessments take place at baseline (prior to initiation of the home exercise program) and at week 6.

Вмешательства

• Поведенческое Motivational Interviewing
  A patient-centered counseling approach consisting of up to 4 face-to-face sessions delivered over 6 weeks. Sessions follow motivational interviewing (MI) principles, including collaborative engagement, open-ended questions, reflective listening, affirmations, and summarizing, to explore ambivalence and elicit change talk. Sessions address goal setting, decisional balance regarding behavior change, and strategies to support adherence to pain self-management and the home exercise program.
• Поведенческое Home Exercise Program
  A standardized 6-week home exercise program taught face-to-face by a physiotherapist, including scalene and upper trapezius stretching (15 seconds per repetition), pectoralis minor stretching (15 seconds per repetition), median and ulnar nerve self-mobilization exercises, scapular stabilization exercises targeting the middle and lower trapezius and rhomboid muscles using elastic resistance bands, and diaphragmatic breathing training. The program is performed 3 times daily, 10 repetitions per exe

Первичные конечные точки

• Pain Intensity (Visual Analog Scale) [Срок оценки: 6 weeks]

Вторичные конечные точки (9)

• Upper Extremity Function (DASH Questionnaire) [Срок оценки: 6 weeks]
• Central Sensitization (Central Sensitization Inventory) [Срок оценки: 6 weeks]
• Kinesiophobia (Tampa Scale of Kinesiophobia) [Срок оценки: 6 weeks]
• Depression, Anxiety and Stress (DASS-21) [Срок оценки: 6 weeks]
• Psychological Resilience (Brief Resilience Scale) [Срок оценки: 6 weeks]
• Pain Self-Efficacy (Pain Self-Efficacy Questionnaire) [Срок оценки: 6 weeks]
• Pain Coping (Pain Coping Inventory) [Срок оценки: 6 weeks]
• Sleep Quality (Jenkins Sleep Scale) [Срок оценки: 6 weeks]
• Anxiety (State-Trait Anxiety Inventory) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Diagnosis of thoracic outlet syndrome
• Age between 18 and 65 years
• Pain duration of more than 6 months
• No surgical intervention in the last 6 months

Критерии исключения

• Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes)
• Unwillingness to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Hacettepe University Faculty of Physical Therapy and Rehabilitation — Ankara

Идентификаторы

NCT: NCT07668206 · FTREK26/38 · FTREK26/38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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