Health TrialsbyHealthPanel

Motivational Interviewing in Thoracic Outlet Syndrome

ConditionThoracic Outlet Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes)

Unwillingness to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Motivational Interviewing + Home ExerciseExperimental treatment 2 interventions
Group B: Home Exercise OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity (Visual Analog Scale)

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.

Time frame
6 weeks

Secondary outcomes

1

Upper Extremity Function (DASH Questionnaire)

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.

Time frame
6 weeks
2

Central Sensitization (Central Sensitization Inventory)

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).

Time frame
6 weeks
3

Kinesiophobia (Tampa Scale of Kinesiophobia)

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.

Time frame
6 weeks
4

Depression, Anxiety and Stress (DASS-21)

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+).

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hacettepe University

Lead sponsor

Source ClinicalTrials.gov
Apply now