Rotator Cuff TearsNCT07664137
Effect of Central Sensitization on Response to Physical Therapy in Patients With Partial Supraspinatus Tear
An observational study of Rotator Cuff Tears, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
This prospective observational study aims to investigate whether central sensitization influences the response to physical therapy in patients with partial supraspinatus tendon tears. Participants will undergo standardized clinical evaluation before treatment and after a 6-week physical therapy program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Standard Physical Therapy and Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Nov 2026
- Phase
- Observational
- 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
Study population: The study population will consist of adult patients aged 18-65 years who are diagnosed with supraspinatus partial-thickness tears based on clinical examination and magnetic resonance imaging (MRI) and are referred for conservative treatment. Participants will be recruited from the outpatient Physical Medicine and Rehabilitation clinic. Eligible patients who meet the inclusion criteria and provide written informed consent will be enrolled consecutively. All participants will receive the same standardized physical therapy and rehabilitation program and will be evaluated at baseline, at the end of treatment, and 6 weeks after completion of treatment.
Who may be able to join
- Adults aged 18 to 65 years. Diagnosis of supraspinatus partial-thickness tear confirmed by clinical examination and magnetic resonance imaging (MRI).
- Presence of shoulder pain for at least 6 weeks. Candidates for a standardized physical therapy and rehabilitation program. Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Full-thickness rotator cuff tear or history of previous shoulder surgery on the affected side.
- Acute fracture, shoulder dislocation, or other major traumatic injury involving the affected shoulder.
- Inflammatory rheumatic diseases, active infection, or malignancy affecting the musculoskeletal system.
- Neurological disorders that may influence pain perception or upper extremity function (e.g., stroke, cervical myelopathy, peripheral neuropathy).
- Severe glenohumeral or acromioclavicular osteoarthritis requiring surgical treatment.
- Receipt of corticosteroid injection or any invasive shoulder intervention within the previous 3 months.
- Participation in another structured rehabilitation program for the affected shoulder within the previous 3 months.
- Pregnancy or inability to comply with the study protocol or complete the required questionnaires.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This prospective observational study aims to investigate whether central sensitization influences the response to physical therapy in patients with partial supraspinatus tendon tears. Participants will undergo standardized clinical evaluation before treatment and after a 6-week physical therapy program. Pain intensity, shoulder function, disability, and central sensitization-related symptoms will be assessed using validated outcome measures. The study seeks to determine the relationship between baseline central sensitization status and treatment outcomes, thereby identifying factors that may predict rehabilitation success and support individualized treatment strategies for patients with partial supraspinatus tears.
Read the detailed description
This prospective observational study aims to investigate the impact of central sensitization on treatment response in patients with supraspinatus partial-thickness tears undergoing a standardized physical therapy and rehabilitation program. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and may contribute to persistent pain and functional impairment beyond the extent of structural tissue damage. Understanding its role may help explain the variability in clinical outcomes among patients receiving similar conservative treatments.
Adult patients diagnosed with a supraspinatus partial-thickness tear by clinical examination and magnetic resonance imaging (MRI) will be enrolled. Before treatment, demographic characteristics, clinical findings, pain intensity, shoulder function, and the presence of central sensitization will be assessed using validated outcome measures. All participants will receive the same standardized physical therapy protocol according to institutional practice.
After completion of the treatment program (e.g., 6 weeks), clinical assessments will be repeated to evaluate changes in pain and functional status. The primary objective is to compare treatment response between patients with and without central sensitization. Secondary analyses will examine the relationship between baseline central sensitization scores and the magnitude of improvement in clinical outcomes while adjusting for potential confounding variables such as age, sex, body mass index, symptom duration, and tear characteristics.
The study is observational in nature, and no experimental intervention, randomization, or additional invasive procedure will be performed beyond routine clinical evaluation and rehabilitation. The findings are expected to provide evidence regarding the prognostic significance of central sensitization in patients with supraspinatus partial-thickness tears and may contribute to the development of more individualized rehabilitation strategies.
- Conditions
- Rotator Cuff Tears
- Being tested
- Standard Physical Therapy and Rehabilitation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical Therapy and RehabilitationBehavioural
All participants will receive the same standardized physical therapy and rehabilitation program administered according to routine clinical practice. The treatment program will include therapeutic exercises, stretching, strengthening, range-of-motion exercises, and appropriate physical therapy modalities as determined by the rehabilitation protocol. No experimental intervention or additional procedure will be performed for research purposes. The study is observational and aims to evaluate whether the presence of central sensitization influences the clinical response to the standardized rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Central Sensitization | Patients with supraspinatus partial-thickness tears who are classified as having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the standardized physical therapy program. Receives: Behavioral: Standard Physical Therapy and Rehabilitation | |
| Patients without Central Sensitization | Patients with supraspinatus partial-thickness tears who are classified as not having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the same standardized physical therapy program. Receives: Behavioral: Standard Physical Therapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI) Total Score
The Shoulder Pain and Disability Index (SPADI) total score will be assessed at baseline, the end of treatment, and 6 weeks after completion of treatment to evaluate changes in pain and shoulder-related disability. A greater reduction in the SPADI total score indicates a better treatment response.
Measured: Baseline, Week 3, and Week 6
Secondary outcomes (1)
Change in Visual Analog Scale (VAS) Pain Score
Pain intensity will be assessed using the Visual Analog Scale (VAS). Changes in VAS scores will be evaluated to determine the effect of treatment over time.
Measured: Baseline, Week 3, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664137
- Sponsor's protocol ID
- KSUH-SS-RCPT-2026-01
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant data collected during this study will not be shared publicly because of participant confidentiality and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Central Sensitization on Response to Physical Therapy in Patients With Partial Supraspinatus Tear
- ClinicalTrials.gov ID
- NCT07664137
- Acronym / sponsor ID
- KSUH-SS-RCPT-2026-01
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 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.
This prospective observational study aims to investigate whether central sensitization influences the response to physical therapy in patients with partial supraspinatus tendon tears. Participants will undergo standardized clinical evaluation before treatment and after a 6-week physical therapy program. Pain intensity, shoulder function, disability, and central sensitization-related symptoms will be assessed using validated outcome measures. The study seeks to determine the relationship between baseline central sensitization status and treatment outcomes, thereby identifying factors that may predict rehabilitation success and support individualized treatment strategies for patients with partial supraspinatus tears.
Detailed description
This prospective observational study aims to investigate the impact of central sensitization on treatment response in patients with supraspinatus partial-thickness tears undergoing a standardized physical therapy and rehabilitation program. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and may contribute to persistent pain and functional impairment beyond the extent of structural tissue damage. Understanding its role may help explain the variability in clinical outcomes among patients receiving similar conservative treatments.
Adult patients diagnosed with a supraspinatus partial-thickness tear by clinical examination and magnetic resonance imaging (MRI) will be enrolled. Before treatment, demographic characteristics, clinical findings, pain intensity, shoulder function, and the presence of central sensitization will be assessed using validated outcome measures. All participants will receive the same standardized physical therapy protocol according to institutional practice.
After completion of the treatment program (e.g., 6 weeks), clinical assessments will be repeated to evaluate changes in pain and functional status. The primary objective is to compare treatment response between patients with and without central sensitization. Secondary analyses will examine the relationship between baseline central sensitization scores and the magnitude of improvement in clinical outcomes while adjusting for potential confounding variables such as age, sex, body mass index, symptom duration, and tear characteristics.
The study is observational in nature, and no experimental intervention, randomization, or additional invasive procedure will be performed beyond routine clinical evaluation and rehabilitation. The findings are expected to provide evidence regarding the prognostic significance of central sensitization in patients with supraspinatus partial-thickness tears and may contribute to the development of more individualized rehabilitation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Central Sensitization | – | Behavioral: Standard Physical Therapy and RehabilitationPatients with supraspinatus partial-thickness tears who are classified as having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the standardized physical therapy program. |
| Patients without Central Sensitization | – | Behavioral: Standard Physical Therapy and RehabilitationPatients with supraspinatus partial-thickness tears who are classified as not having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the same standardized physical therapy program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18-65 years who are diagnosed with supraspinatus partial-thickness tears based on clinical examination and magnetic resonance imaging (MRI) and are referred for conservative treatment. Participants will be recruited from the outpatient Physical Medicine and Rehabilitation clinic. Eligible patients who meet the inclusion criteria and provide written informed consent will be enrolled consecutively. All participants will receive the same standardized physical therapy and rehabilitation program and will be evaluated at baseline, at the end of treatment, and 6 weeks after completion of treatment.
Key inclusion criteria (2 listed)
- Adults aged 18 to 65 years. Diagnosis of supraspinatus partial-thickness tear confirmed by clinical examination and magnetic resonance imaging (MRI).
- Presence of shoulder pain for at least 6 weeks. Candidates for a standardized physical therapy and rehabilitation program. Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (8 listed)
- Full-thickness rotator cuff tear or history of previous shoulder surgery on the affected side.
- Acute fracture, shoulder dislocation, or other major traumatic injury involving the affected shoulder.
- Inflammatory rheumatic diseases, active infection, or malignancy affecting the musculoskeletal system.
- Neurological disorders that may influence pain perception or upper extremity function (e.g., stroke, cervical myelopathy, peripheral neuropathy).
- Severe glenohumeral or acromioclavicular osteoarthritis requiring surgical treatment.
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 |
|---|---|---|
| Standard Physical Therapy and RehabilitationAll participants will receive the same standardized physical therapy and rehabilitation program administered according to routine clinical practice. The treatment program will include therapeutic exercises, stretching, strengthening, range-of-motion exercises, and appropriate physical therapy modalities as determined by the rehabilitation protocol. No experimental intervention or additional procedure will be performed for research purposes. The study is observational and aims to evaluate whether the presence of central sensitization influences the clinical response to the standardized rehabilitation program. | Behavioural | Patients with Central Sensitization, Patients without Central Sensitization |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI) Total Score
Time frame: Baseline, Week 3, and Week 6
The Shoulder Pain and Disability Index (SPADI) total score will be assessed at baseline, the end of treatment, and 6 weeks after completion of treatment to evaluate changes in pain and shoulder-related disability. A greater reduction in the SPADI total score indicates a better treatment response.
1 secondary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, Week 3, and Week 6
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 24 Jun 2026.
- Individual participant dataSharing planned: No. No. Individual participant data collected during this study will not be shared publicly because of participant confidentiality and institutional data protection policies.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Kanuni Sultan Suleyman Training and Research Hospital.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zeynep Karakuzu Güngör, M.D (+90 (212) 404 15 00., zeynepkarakuzu@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain and Disability Index (SPADI) Total Score (time frame: Baseline, Week 3, and Week 6). 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 24 Jun 2026.