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NCT Number: NCT07668206

Motivational Interviewing in Thoracic Outlet Syndrome

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location contact

Ayten Kayı Cangır, Prof

SUB_INVESTIGATOR

Gülay Uzun, MSc, PT

SUB_INVESTIGATOR

Nur Sena Yarımkaya, MSc, PT, Psychologist

SUB_INVESTIGATOR

Tüzün Fırat, Prof

PRINCIPAL_INVESTIGATOR

Şule T Tüzen Tek, MSc, PT

SUB_INVESTIGATOR

Şule Tüzen Tek, MSc, PT

CONTACT

[email protected]

+905076370001

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Home Exercise Program

Behavioral

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.

Primary outcomes

  1. Pain Intensity (Visual Analog Scale)

    Time frame: 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 outcomes

  1. Upper Extremity Function (DASH Questionnaire)

    Time frame: 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.

  2. Central Sensitization (Central Sensitization Inventory)

    Time frame: 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).

  3. Kinesiophobia (Tampa Scale of Kinesiophobia)

    Time frame: 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.

  4. Depression, Anxiety and Stress (DASS-21)

    Time frame: 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+).

  5. Psychological Resilience (Brief Resilience Scale)

    Time frame: 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.

  6. Pain Self-Efficacy (Pain Self-Efficacy Questionnaire)

    Time frame: 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.

  7. Pain Coping (Pain Coping Inventory)

    Time frame: 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.

  8. Sleep Quality (Jenkins Sleep Scale)

    Time frame: 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.

  9. Anxiety (State-Trait Anxiety Inventory)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tüzün Fırat, Prof

CONTACT

[email protected]

+905326710635

Şule Tüzen Tek, MSc, PT

CONTACT

[email protected]

+905076370001

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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