Neuropathic Pain, Catastrophizing, and Adherence in SAIS

April 2, 2026 updated by: yakuperden, Abant Izzet Baysal University

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

Recruiting

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

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bolu, Turkey (Türkiye), 14020
        • Recruiting
        • AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Component (DN4)
Time Frame: Baseline and 2 weeks
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
Baseline and 2 weeks
Pain Catastrophizing (PCS)
Time Frame: Baseline and 2 weeks
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
Baseline and 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity at Rest (VAS)
Time Frame: Baseline and 2 weeks
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.
Baseline and 2 weeks
Pain Intensity During Activity (VAS)
Time Frame: Baseline and 2 weeks
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.
Baseline and 2 weeks
Pain Intensity at Night (VAS)
Time Frame: Baseline and 2 weeks
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.
Baseline and 2 weeks
Functional Status (DASH)
Time Frame: Baseline and 2 weeks
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.
Baseline and 2 weeks
Anxiety and Depression (HADS)
Time Frame: Baseline and 2 weeks
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.
Baseline and 2 weeks
Adherence-Related Behavior (MMAS)
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional policies and ethical considerations regarding patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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