NCT07668206

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jun 2026Oct 2027

Study Start

First participant enrolled

June 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Keywords

Motivational InterviewingChronic PainHome Exercise ProgramPsychological ResilienceCentral SensitizationThoracic Outlet Syndrome

Outcome Measures

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.

    6 weeks

Secondary Outcomes (9)

  • Upper Extremity Function (DASH Questionnaire)

    6 weeks

  • Central Sensitization (Central Sensitization Inventory)

    6 weeks

  • Kinesiophobia (Tampa Scale of Kinesiophobia)

    6 weeks

  • Depression, Anxiety and Stress (DASS-21)

    6 weeks

  • Psychological Resilience (Brief Resilience Scale)

    6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Motivational Interviewing + Home Exercise

EXPERIMENTAL

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

Behavioral: Motivational InterviewingBehavioral: Home Exercise Program

Home Exercise Only

ACTIVE COMPARATOR

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.

Behavioral: Home Exercise Program

Interventions

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.

Motivational Interviewing + Home Exercise

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.

Home Exercise OnlyMotivational Interviewing + Home Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes)
  • Unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thoracic Outlet SyndromeChronic Pain

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tüzün Fırat, Prof

    Hacettepe University Faculty of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şule Tüzen Tek, MSc, PT

CONTACT

Tüzün Fırat, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Tüzün Fırat

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 25, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations