Neuropathic Pain, Catastrophizing, and Adherence in SAIS

NCT07509021 | Recruiting

• 1 other identifier: AIBU-FTR-YE-02
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial Impingement Syndrome; Neuropathic Pain; Pain Catastrophizing; Shoulder Pain; Adherence-related behavior

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline and 2 weeks

• 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.

  Baseline and 2 weeks

Secondary Outcomes (6)

• Pain Intensity at Rest (VAS)

  Baseline and 2 weeks

• Pain Intensity During Activity (VAS)

  Baseline and 2 weeks

• Pain Intensity at Night (VAS)

  Baseline and 2 weeks

• Functional Status (DASH)

  Baseline and 2 weeks

• Anxiety and Depression (HADS)

  Baseline and 2 weeks

Study Arms (1)

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.

Other: Standard Conservative Physical Therapy

Interventions

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.

Patients with Subacromial Impingement Syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital

Bolu, 14020, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 29565960 BACKGROUND

• 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.

  PMID: 36143137 BACKGROUND

• 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.

  PMID: 35993637 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Neuralgia; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia

Study Officials

• Yakup ERDEN, MD

  Clinic of Physical Medicine and Rehabilitation, İzzet Baysal Physical Treatment and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yakup ERDEN, MD

CONTACT

+905556692721; yakuperden@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 3, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)