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Motivational Interviewing in Thoracic Outlet Syndrome

15 september 2026 uppdaterad av: 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Turkiet (Türkiye)
      • Ankara, Turkiet (Türkiye)
        • Rekrytering
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation
        • Kontakt:
        • Huvudutredare:
          • Tüzün Fırat, Prof
        • Underutredare:
          • Nur Sena Yarımkaya, MSc, PT, Psychologist
        • Underutredare:
          • Gülay Uzun, MSc, PT
        • Underutredare:
          • Ayten Kayı Cangır, Prof
        • Underutredare:
          • Şule T Tüzen Tek, MSc, PT

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Beteende: 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.
Beteende: 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.
Aktiv komparator: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Intensity (Visual Analog Scale)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Upper Extremity Function (DASH Questionnaire)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hacettepe University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

1 oktober 2027

Studieregistreringsdatum

Först inskickad

19 juni 2026

Först inskickad som uppfyllde QC-kriterierna

19 juni 2026

Första postat (Faktisk)

25 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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