Subacromial Impingement SyndromeNCT07509021
Neuropathic Pain, Catastrophizing, and Adherence in SAIS
An observational study of Subacromial Impingement Syndrome, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Subacromial impingement syndrome is one of the most common causes of shoulder pain and may negatively affect daily activities and quality of life. While shoulder pain is usually considered nociceptive, some patients may also have a neuropathic pain component, which can influence symptom severity and treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Standard Conservative Physical Therapy
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 consists of adult patients aged 18-65 years diagnosed with unilateral subacromial impingement syndrome who are referred to an outpatient physical therapy and rehabilitation clinic. Patients with symptoms lasting at least three months. Participants scheduled to undergo a standard conservative physical therapy program will be included.
Who may be able to join
- Unilateral subacromial impingement syndrome lasting at least 3 months
- Planned to start a 10-session physical therapy program
- Willing and able to provide informed consent
Who cannot join
- Upper extremity entrapment neuropathy or polyneuropathy
- History of diabetes mellitus
- Inflammatory rheumatic disease, infection, or malignancy
- Frozen shoulder
- History of shoulder fracture, dislocation, or surgery
- Complete rotator cuff tear on magnetic resonance imaging
Show all 11Show fewer
- Calcific tendinitis
- Shoulder steroid injection or physical therapy within the previous 3 months
- Use of medication for neuropathic pain
- Pregnancy
- Cognitive impairment preventing completion of questionnaires
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital
Bolu, 14020
About this study
Official title: The Relationship Between Neuropathic Pain, Pain Catastrophizing, and Adherence-Related Behavior in Subacromial Impingement Syndrome
Subacromial impingement syndrome is one of the most common causes of shoulder pain and may negatively affect daily activities and quality of life. While shoulder pain is usually considered nociceptive, some patients may also have a neuropathic pain component, which can influence symptom severity and treatment outcomes. In addition, psychological factors such as pain catastrophizing and adherence-related behavior may play an important role in recovery.
This prospective observational study aims to evaluate the presence of neuropathic pain in patients with subacromial impingement syndrome and to investigate its relationship with pain catastrophizing and adherence-related behavior. Patients undergoing a standard physical therapy program will be assessed at the beginning and after completion of treatment using validated clinical scales.
The findings of this study may help to better understand the interaction between pain characteristics, psychological factors, and adherence-related behavior, and contribute to the development of more individualized rehabilitation strategies
Read the detailed description
Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and represents a substantial proportion of rotator cuff-related shoulder disorders. Although it is traditionally associated with nociceptive and mechanical pain mechanisms, recent evidence suggests that a subset of patients may also present with a neuropathic pain component and central sensitization, which may contribute to increased pain intensity, functional impairment, and poorer treatment outcomes.
In addition to biological factors, psychosocial variables play a critical role in chronic musculoskeletal pain. Pain catastrophizing, reflecting exaggerated negative cognitive and emotional responses to pain, has been associated with increased disability and delayed recovery. Similarly, adherence-related behavior may influence clinical outcomes, particularly in the context of physical therapy and exercise-based interventions. Understanding the interaction between neuropathic pain, catastrophizing, and adherence-related behavior may help identify clinically relevant subgroups and guide individualized rehabilitation strategies.
This study is designed as a prospective observational cohort study conducted in patients diagnosed with subacromial impingement syndrome who are referred to an outpatient physical therapy and rehabilitation clinic. Participants who meet the inclusion criteria will be consecutively enrolled and will receive a standard conservative physical therapy program. No additional or experimental interventions will be applied within the scope of the study.
Clinical and patient-reported outcome measures will be used to assess pain characteristics, psychological factors, functional status, and adherence-related behavior.
The primary aim of the study is to evaluate the relationship between neuropathic pain and pain catastrophizing in patients with subacromial impingement syndrome. Secondary analyses will explore the associations between these variables and adherence-related behavior, as well as clinical outcomes such as pain intensity and functional status.
The findings of this study are expected to contribute to a better understanding of the multidimensional nature of shoulder pain and to support the development of more targeted and individualized rehabilitation approaches.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Standard Conservative Physical Therapy
- Keywords
- Subacromial Impingement Syndrome, Neuropathic Pain, Pain Catastrophizing, Shoulder Pain, Adherence-related behavior
- Medical subject headings
- Shoulder Impingement Syndrome, Neuralgia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Conservative Physical TherapyOther
Participants receive a standard conservative physical therapy program as part of routine clinical care. No experimental or study-assigned intervention is applied within the scope of this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Subacromial Impingement Syndrome | Adults diagnosed with subacromial impingement syndrome who are scheduled to receive a standard conservative physical therapy program and are evaluated for neuropathic pain, pain catastrophizing, and treatment adherence. Receives: Other: Standard Conservative Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Component (DN4)
Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4). Total scores range from 0 to 10, with higher scores indicating a greater neuropathic pain component. A score of ≥4 will be considered indicative of neuropathic pain
Measured: Baseline
Pain Catastrophizing (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
Measured: Baseline
Secondary outcomes (6)
Pain Intensity at Rest (VAS)
Pain intensity at rest will be assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Baseline and 2 weeks
Pain Intensity During Activity (VAS)
Pain intensity during activity will be assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Baseline and 2 weeks
Pain Intensity at Night (VAS)
Night pain intensity will be assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Baseline and 2 weeks
Functional Status (DASH)
Functional status will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline and 2 weeks
Anxiety and Depression (HADS)
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes two subscales (HADS-A and HADS-D). Higher scores indicate greater symptom severity.
Measured: Baseline
Adherence-Related Behavior (MMAS)
Adherence-related behavior will be assessed using the Morisky Medication Adherence Scale (MMAS), a self-reported measure originally developed to evaluate medication adherence. Although primarily designed for medication adherence, it will be used in this study as an indicator of general adherence-related behavior. Higher scores indicate better adherence-related behavior.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start2 Apr 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yakup Erden, MD, Abant Izzet Baysal University
- Investigators
- Yakup ERDEN, MD, Principal investigator, Clinic of Physical Medicine and Rehabilitation, İzzet Baysal Physical Treatment and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509021
- Sponsor's protocol ID
- AIBU-FTR-YE-02
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 21 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 institutional policies and ethical considerations regarding patient confidentiality.
Publications
Ko S, Choi C, Kim S, Chae S, Choi W, Kwon J. Prevalence and Risk Factors of Neuropathic Pain in Patients with a Rotator Cuff Tear. Pain Physician. 2018 Mar;21(2):E173-E180.
PubMed 29565960Vogel M, Binnebose M, Wallis H, Lohmann CH, Junne F, Berth A, Riediger C. The Unhappy Shoulder: A Conceptual Review of the Psychosomatics of Shoulder Pain. J Clin Med. 2022 Sep 19;11(18):5490. doi: 10.3390/jcm11185490.
PubMed 36143137Ucar M, Cebicci MA, Koca I, Arik HO. Frequency of neuropathic pain in patients with shoulder pain. Eur Rev Med Pharmacol Sci. 2022 Aug;26(15):5422-5425. doi: 10.26355/eurrev_202208_29410.
PubMed 35993637
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Neuropathic Pain, Pain Catastrophizing, and Adherence-Related Behavior in Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT07509021
- Acronym / sponsor ID
- AIBU-FTR-YE-02
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Subacromial Impingement Syndrome, Neuropathic Pain, Pain Catastrophizing, Shoulder Pain, Adherence-related behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 3 Apr 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.
Subacromial impingement syndrome is one of the most common causes of shoulder pain and may negatively affect daily activities and quality of life. While shoulder pain is usually considered nociceptive, some patients may also have a neuropathic pain component, which can influence symptom severity and treatment outcomes. In addition, psychological factors such as pain catastrophizing and adherence-related behavior may play an important role in recovery.
This prospective observational study aims to evaluate the presence of neuropathic pain in patients with subacromial impingement syndrome and to investigate its relationship with pain catastrophizing and adherence-related behavior. Patients undergoing a standard physical therapy program will be assessed at the beginning and after completion of treatment using validated clinical scales.
The findings of this study may help to better understand the interaction between pain characteristics, psychological factors, and adherence-related behavior, and contribute to the development of more individualized rehabilitation strategies
Detailed description
Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and represents a substantial proportion of rotator cuff-related shoulder disorders. Although it is traditionally associated with nociceptive and mechanical pain mechanisms, recent evidence suggests that a subset of patients may also present with a neuropathic pain component and central sensitization, which may contribute to increased pain intensity, functional impairment, and poorer treatment outcomes.
In addition to biological factors, psychosocial variables play a critical role in chronic musculoskeletal pain. Pain catastrophizing, reflecting exaggerated negative cognitive and emotional responses to pain, has been associated with increased disability and delayed recovery. Similarly, adherence-related behavior may influence clinical outcomes, particularly in the context of physical therapy and exercise-based interventions. Understanding the interaction between neuropathic pain, catastrophizing, and adherence-related behavior may help identify clinically relevant subgroups and guide individualized rehabilitation strategies.
This study is designed as a prospective observational cohort study conducted in patients diagnosed with subacromial impingement syndrome who are referred to an outpatient physical therapy and rehabilitation clinic. Participants who meet the inclusion criteria will be consecutively enrolled and will receive a standard conservative physical therapy program. No additional or experimental interventions will be applied within the scope of the study.
Clinical and patient-reported outcome measures will be used to assess pain characteristics, psychological factors, functional status, and adherence-related behavior.
The primary aim of the study is to evaluate the relationship between neuropathic pain and pain catastrophizing in patients with subacromial impingement syndrome. Secondary analyses will explore the associations between these variables and adherence-related behavior, as well as clinical outcomes such as pain intensity and functional status.
The findings of this study are expected to contribute to a better understanding of the multidimensional nature of shoulder pain and to support the development of more targeted and individualized rehabilitation approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Subacromial Impingement Syndrome | – | Other: Standard Conservative Physical TherapyAdults diagnosed with subacromial impingement syndrome who are scheduled to receive a standard conservative physical therapy program and are evaluated for neuropathic pain, pain catastrophizing, and treatment adherence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18-65 years diagnosed with unilateral subacromial impingement syndrome who are referred to an outpatient physical therapy and rehabilitation clinic. Patients with symptoms lasting at least three months. Participants scheduled to undergo a standard conservative physical therapy program will be included.
Key inclusion criteria (3 listed)
- Unilateral subacromial impingement syndrome lasting at least 3 months
- Planned to start a 10-session physical therapy program
- Willing and able to provide informed consent
Key exclusion criteria (11 listed)
- Upper extremity entrapment neuropathy or polyneuropathy
- History of diabetes mellitus
- Inflammatory rheumatic disease, infection, or malignancy
- Frozen shoulder
- History of shoulder fracture, dislocation, or surgery
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 Conservative Physical TherapyParticipants receive a standard conservative physical therapy program as part of routine clinical care. No experimental or study-assigned intervention is applied within the scope of this study. | Other | Patients with Subacromial Impingement Syndrome |
Primary outcome
Neuropathic Pain Component (DN4)
Time frame: Baseline
Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4). Total scores range from 0 to 10, with higher scores indicating a greater neuropathic pain component. A score of ≥4 will be considered indicative of neuropathic pain
Pain Catastrophizing (PCS)
Time frame: Baseline
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
6 secondary outcomes
Pain Intensity at Rest (VAS)
Time frame: Baseline and 2 weeks
Pain Intensity During Activity (VAS)
Time frame: Baseline and 2 weeks
Pain Intensity at Night (VAS)
Time frame: Baseline and 2 weeks
Functional Status (DASH)
Time frame: Baseline and 2 weeks
Anxiety and Depression (HADS)
Time frame: Baseline
Adherence-Related Behavior (MMAS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 29565960Ko S, Choi C, Kim S, Chae S, Choi W, Kwon J. Prevalence and Risk Factors of Neuropathic Pain in Patients with a Rotator Cuff Tear. Pain Physician. 2018 Mar;21(2):E173-E180.
- Background: PubMed 36143137Vogel M, Binnebose M, Wallis H, Lohmann CH, Junne F, Berth A, Riediger C. The Unhappy Shoulder: A Conceptual Review of the Psychosomatics of Shoulder Pain. J Clin Med. 2022 Sep 19;11(18):5490. doi: 10.3390/jcm11185490.
- Background: PubMed 35993637Ucar M, Cebicci MA, Koca I, Arik HO. Frequency of neuropathic pain in patients with shoulder pain. Eur Rev Med Pharmacol Sci. 2022 Aug;26(15):5422-5425. doi: 10.26355/eurrev_202208_29410.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and ethical considerations regarding patient confidentiality.
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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. This study is not recruiting at the moment.
Yakup ERDEN, MD principal investigator
Clinic of Physical Medicine and Rehabilitation, İzzet Baysal Physical Treatment and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subacromial Impingement Syndrome, run by Abant Izzet Baysal 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Component (DN4) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509021, which also lists 3 linked publications.
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 21 Sep 2026.