Thoracic Outlet SyndromeNCT07668206
Motivational Interviewing in Thoracic Outlet Syndrome
A study testing Motivational Interviewing and Home Exercise Program in people with Thoracic Outlet Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Motivational Interviewing and Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes)
- Unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara
Şule Tüzen Tek, MSc, PT, +905076370001, sule.tuzen@gmail.com
Tüzün Fırat, Prof
About this study
Official title: 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.
Read more
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
Read the detailed description
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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Motivational Interviewing, Home Exercise Program
- Keywords
- Motivational Interviewing, Chronic Pain, Home Exercise Program, Psychological Resilience, Central Sensitization, Thoracic Outlet Syndrome
- Medical subject headings
- Thoracic Outlet Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Motivational Interviewing; Behavioral: 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. Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (9)
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.
Measured: 6 weeks
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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+).
Measured: 6 weeks
Psychological Resilience (Brief Resilience Scale)
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.
Measured: 6 weeks
Pain Self-Efficacy (Pain Self-Efficacy Questionnaire)
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.
Measured: 6 weeks
Pain Coping (Pain Coping Inventory)
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.
Measured: 6 weeks
Sleep Quality (Jenkins Sleep Scale)
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.
Measured: 6 weeks
Anxiety (State-Trait Anxiety Inventory)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tüzün Fırat, Hacettepe University
- Investigators
- Tüzün Fırat, Prof, Principal investigator, Hacettepe University Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668206
- Sponsor's protocol ID
- FTREK26/38
- Other IDs
- FTREK26/38
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Thoracic Outlet Syndrome Symptoms in Patients With Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT07668206
- Acronym / sponsor ID
- FTREK26/38
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Motivational Interviewing, Chronic Pain, Home Exercise Program, Psychological Resilience, Central Sensitization, Thoracic Outlet Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing + Home Exercise | Experimental | Behavioral: Motivational Interviewing, Behavioral: Home Exercise ProgramParticipants 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 |
| Home Exercise Only | Active comparator | Behavioral: Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes)
- Unwillingness to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingA 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. | Behavioural | Motivational Interviewing + Home Exercise |
| Home Exercise ProgramA 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. | Behavioural | Home Exercise Only, Motivational Interviewing + Home Exercise |
Primary outcome
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.
9 secondary outcomes
Upper Extremity Function (DASH Questionnaire)
Time frame: 6 weeks
Central Sensitization (Central Sensitization Inventory)
Time frame: 6 weeks
Kinesiophobia (Tampa Scale of Kinesiophobia)
Time frame: 6 weeks
Depression, Anxiety and Stress (DASS-21)
Time frame: 6 weeks
Psychological Resilience (Brief Resilience Scale)
Time frame: 6 weeks
Pain Self-Efficacy (Pain Self-Efficacy Questionnaire)
Time frame: 6 weeks
Pain Coping (Pain Coping Inventory)
Time frame: 6 weeks
Sleep Quality (Jenkins Sleep Scale)
Time frame: 6 weeks
Anxiety (State-Trait Anxiety Inventory)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tüzün Fırat, Prof principal investigator
Hacettepe University Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Home Exercise Program in people with Thoracic Outlet Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şule Tüzen Tek, MSc, PT (+905076370001, sule.tuzen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Visual Analog Scale) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.