- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509021
Neuropathic Pain, Catastrophizing, and Adherence in SAIS
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yakup ERDEN, MD
- Phone Number: +905556692721
- Email: yakuperden@hotmail.com
Study Locations
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Bolu, Turkey (Türkiye), 14020
- Recruiting
- AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropathic Pain Component (DN4)
Time Frame: Baseline and 2 weeks
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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
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Baseline and 2 weeks
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Pain Catastrophizing (PCS)
Time Frame: Baseline and 2 weeks
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Pain catastrophizing will be assessed using the Pain Catastrophizing Scale.
Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
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Baseline and 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity at Rest (VAS)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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Pain Intensity During Activity (VAS)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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Pain Intensity at Night (VAS)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
|
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Functional Status (DASH)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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Anxiety and Depression (HADS)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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Adherence-Related Behavior (MMAS)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yakup ERDEN, MD, Clinic of Physical Medicine and Rehabilitation, İzzet Baysal Physical Treatment and Rehabilitation Training and Research Hospital
Publications and helpful links
General 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.
- Vogel 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.
- Ucar 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Shoulder Injuries
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Joint Diseases
- Peripheral Nervous System Diseases
- Arthralgia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neuralgia
- Shoulder Pain
- Shoulder Impingement Syndrome
Other Study ID Numbers
- AIBU-FTR-YE-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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