The Segmental Distribution of Hypersensitivity in Patients With Chronic Subacromial Pain Syndrome

NCT06139120 | Completed

• 1 other identifier: 125/14
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the distribution of pain sensitivity according to body segments in patients with central sensitization associated with chronic subacromial pain syndrome (SPS).This cross-sectional study included patients with chronic SPS and central sensitization (patient group) and the same number of healthy participants as controls. The presence of central sensitization was determined using the Central Sensitization Inventory. To determine the segmental distribution of pain sensitivity, pressure pain threshold measurements were performed bilaterally from the shoulder, forearm, and leg.

Conditions

Subacromial Pain Syndrome; Central Sensitisation

Keywords

shoulder pain; hypersensitivity; pressure pain threshold

Outcome Measures

Primary Outcomes (2)

• Pressure pain threshold (PPT) measurement

  PPT is the lowest amount of pressure at which pain is felt. The current study used a manual algometer (Force Dial FDK 20, Wagner, Greenwich, USA) with a rubber tip and a surface area of 1 cm2 for PPT measurements. The measurements were performed bilaterally from the shoulder (midpoint of deltoid muscle), forearm (midpoint of brachioradialis muscle), and leg (midpoint of tibialis anterior muscle).

  Baseline

• Central sensitization inventory (CSI)

  The CSI was used to determine the presence of central sensitization in the participants. The CSI contains 25 items related to central sensitization symptoms scored on a four-point Likert scale, with the total score ranging from 0 to 100. A cutoff score of 40 or greatest indicates the presence of central sensitization.

  Baseline

Study Arms (2)

Chronic subacromial pain

Patients with central sensitization associated with chronic pain syndrome

Diagnostic Test: Assessment of hypersensitivity

Control

Healthy participants

Diagnostic Test: Assessment of hypersensitivity

Interventions

Assessment of hypersensitivity DIAGNOSTIC_TEST

Assessment of pain hypersensitivity in body segments was performed using pressure pain measurement

Chronic subacromial pain; Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Physical medicine and rehabilitation clinic

You may qualify if:

• To be diagnosed with chronic (≥ 3 months) unilateral SPS according to clinical examination (the Hawkins-Kennedy test and the painful arc test) and/or imaging.
• To be scored ≥ 40 on CSI

You may not qualify if:

• i) Bilateral shoulder pain syndrome, ii) History ofshoulder surgery, iii) Osteoarthritis of the glenohumeral joint on direct radiography, v)concomitant diseases with the potential risk of development of central/peripheral sensitization \[diseases specified in CSI part B, vi) symptomatic lateral/central spinal stenosis, myelopathy, or radiculopathy, vii) history of centrally acting drug use (e.g.,pregabalin, gabapentin, amitriptyline, duloxetine, and opioid) viii) alcohol/substance abuse.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain; Hypersensitivity

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: September 20, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 30, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)