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Motivational Interviewing in Thoracic Outlet Syndrome

15 september 2026 bijgewerkt door: Tüzün Fırat, Hacettepe University

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
      • Ankara, Turkije (Türkiye)
        • Werving
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation
        • Contact:
        • Hoofdonderzoeker:
          • Tüzün Fırat, Prof
        • Onderonderzoeker:
          • Nur Sena Yarımkaya, MSc, PT, Psychologist
        • Onderonderzoeker:
          • Gülay Uzun, MSc, PT
        • Onderonderzoeker:
          • Ayten Kayı Cangır, Prof
        • Onderonderzoeker:
          • Şule T Tüzen Tek, MSc, PT

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Motivational Interviewing + Home Exercise
Participants randomly assigned to this arm receive a standardized 6-week home exercise program in addition to up to 4 face-to-face motivational interviewing (MI) sessions. The first two MI sessions are conducted one week apart, and the remaining two sessions two weeks apart, completing all 4 sessions within 6 weeks. MI sessions are delivered by a physiotherapist and a clinical psychologist trained in motivational interviewing techniques, and address ambivalence, goal setting, and behavior change related to pain management and adherence to the exercise program. The home exercise program is taught face-to-face by a physiotherapist and includes scalene and upper trapezius stretching, pectoralis minor stretching, median and ulnar nerve mobilization exercises, scapular stabilization exercises (middle/lower trapezius and rhomboids), and diaphragmatic breathing training, to be performed 3 times daily, 10 repetitions per sessio
Gedragsmatig: 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.
Gedragsmatig: 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 exercise, for 6 weeks. Participants maintain an exercise diary to track adherence.
Actieve vergelijker: Home Exercise Only
Participants randomly assigned to this arm receive the same standardized 6-week home exercise program as the experimental arm, without motivational interviewing sessions. The home exercise program is taught face-to-face by a physiotherapist and includes scalene and upper trapezius stretching, pectoralis minor stretching, median and ulnar nerve mobilization exercises, scapular stabilization exercises (middle/lower trapezius and rhomboids), and diaphragmatic breathing training, to be performed 3 times daily, 10 repetitions per session, for 6 weeks.
Gedragsmatig: 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 exercise, for 6 weeks. Participants maintain an exercise diary to track adherence.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity (Visual Analog Scale)
Tijdsspanne: 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.
6 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Upper Extremity Function (DASH Questionnaire)
Tijdsspanne: 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.
6 weeks
Central Sensitization (Central Sensitization Inventory)
Tijdsspanne: 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).
6 weeks
Kinesiophobia (Tampa Scale of Kinesiophobia)
Tijdsspanne: 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.
6 weeks
Depression, Anxiety and Stress (DASS-21)
Tijdsspanne: 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+).
6 weeks
Psychological Resilience (Brief Resilience Scale)
Tijdsspanne: 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 weeks
Pain Self-Efficacy (Pain Self-Efficacy Questionnaire)
Tijdsspanne: 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.
6 weeks
Pain Coping (Pain Coping Inventory)
Tijdsspanne: 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.
6 weeks
Sleep Quality (Jenkins Sleep Scale)
Tijdsspanne: 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.
6 weeks
Anxiety (State-Trait Anxiety Inventory)
Tijdsspanne: 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.
6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hacettepe University

Onderzoekers

  • Hoofdonderzoeker: Tüzün Fırat, Prof, Hacettepe University Faculty of Physical Therapy and Rehabilitation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

19 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FTREK26/38 (Andere identificatie: Hacettepe University Faculty of Physical Therapy and Rehabilitation Research Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared due to ethical and privacy considerations related to the sensitive nature of the psychological and pain-related data collected, and because no data sharing infrastructure or participant consent for external data sharing was established for this study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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