Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07509021

Neuropathic Pain, Catastrophizing, and Adherence in SAIS

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital

Bolu, 14020, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Conservative Physical Therapy

Other

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yakup ERDEN, MD

CONTACT

[email protected]

+905556692721

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Relationship Between Neuropathic Pain, Pain Catastrophizing, and Adherence-Related Behavior in Subacromial Impingement Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.