Thoracic Outlet Syndrome
Conditions
Keywords
Motivational Interviewing, Chronic Pain, Home Exercise Program, Psychological Resilience, Central Sensitization, Thoracic Outlet Syndrome
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALMotivational 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.
BEHAVIORALHome 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 exercise, for 6 weeks. Participants maintain an exercise diary to track adherence.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes) * Unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Visual Analog Scale) | 6 weeks | Pain intensity assessed using a 10 cm Visual Analog Scale (VAS), separately for pain at rest, during activity, and at night. Scores range from 0 (no pain) to 10 (unbearable pain). Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Function (DASH Questionnaire) | 6 weeks | Upper extremity function and symptoms assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, a 30-item scale covering daily activities, symptoms, and social/work/sleep impact. Scores are transformed to range from 0 to 100. Higher scores indicate greater disability. |
| Central Sensitization (Central Sensitization Inventory) | 6 weeks | Central sensitization-related symptoms assessed using Part A of the Central Sensitization Inventory (CSI), a 25-item questionnaire with each item scored from 0 (never) to 4 (always). Total scores range from 0 to 100. Higher scores indicate greater central sensitization. A cut-off score of 40 or above is widely used to indicate clinically significant central sensitization, with severity classified as subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), or extreme (60-100). |
| Kinesiophobia (Tampa Scale of Kinesiophobia) | 6 weeks | Fear of movement and re-injury assessed using the Tampa Scale of Kinesiophobia (TSK), a 17-item questionnaire with each item scored from 1 (strongly disagree) to 4 (strongly agree). Total scores range from 17 to 68. Higher scores indicate greater kinesiophobia. |
| Depression, Anxiety and Stress (DASS-21) | 6 weeks | Depression, anxiety, and stress symptoms assessed using the Depression Anxiety Stress Scale-21 (DASS-21), a 21-item scale with 7 items per subscale (Depression, Anxiety, Stress), each item scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Subscale raw scores are summed and multiplied by 2 to allow comparison with normative data from the original 42-item DASS. Higher scores indicate greater severity. Severity is classified using standard cut-offs: Depression (Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+), Anxiety (Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+), and Stress (Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+). |
| Psychological Resilience (Brief Resilience Scale) | 6 weeks | Psychological resilience assessed using the Brief Resilience Scale (BRS), a 6-item scale with each item scored from 1 (strongly disagree) to 5 (strongly agree); 3 items are reverse-scored. Total scores range from 1.00 to 5.00. Scores are classified as low (1.00-2.99), normal (3.00-4.30), or high (4.31-5.00) resilience. |
| Pain Self-Efficacy (Pain Self-Efficacy Questionnaire) | 6 weeks | Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item scale with each item scored from 0 (not at all confident) to 6 (completely confident). Total scores range from 0 to 60. Higher scores indicate greater pain self-efficacy. |
| Pain Coping (Pain Coping Inventory) | 6 weeks | Pain coping strategies assessed using the Pain Coping Inventory (PCI), a 22-item scale covering 6 subscales of active coping (distraction, pain transformation, reducing demands) and passive coping (worrying, resting, retreating). Each item is scored from 1 (rarely or never) to 4 (very often). Higher subscale scores indicate greater use of that coping strategy. There is no universally established cut-off value; subscale scores are interpreted continuously. |
| Sleep Quality (Jenkins Sleep Scale) | 6 weeks | Sleep disturbance assessed using the Jenkins Sleep Scale, a 4-item questionnaire with each item scored from 0 (not at all) to 5 (22-28 nights). Total scores range from 0 to 20. Higher scores indicate greater sleep disturbance. |
| Anxiety (State-Trait Anxiety Inventory) | 6 weeks | State and trait anxiety assessed using the State-Trait Anxiety Inventory (STAI), a 40-item scale (20 items per subscale) with each item scored from 1 to 4. Subscale scores range from 20 to 80. Higher scores indicate greater anxiety. There is no universally established cut-off value; scores are interpreted continuously. |
Countries
Turkey (Türkiye)
Contacts
CONTACTŞule Tüzen Tek, MSc, PT
CONTACTTüzün Fırat, Prof
PRINCIPAL_INVESTIGATORTüzün Fırat, Prof
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Outcome results
None listed