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

November 15, 2023 updated by: Volkan Deniz, PT, Cukurova University

Evaluation of the Segmental Distribution of Pain Hypersensitivity Among Patients With Central Sensitization Associated With Chronic Subacromial Pain Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Shoulder pain is a common musculoskeletal pain condition in the general population, with a prevalence that has doubled in all age groups over the past 40 years, reaching 22%-30%. Despite treatment, at least 40% of patients report incomplete improvement in pain severity and duration of symptoms, which are the two main determinants of treatment response. There is convincing evidence that the persistence of pain in these patients is due to peripheral or central sensitization mechanisms. Central sensitization refers to pain hypersensitivity mainly resulting from amplifying central nervous system signals and reduced activity of central inhibitory pathways. The clinical presence of central sensitization is determined by examining specific pain characteristics or evaluating changes in pain threshold. The objective manifestation of central sensitization is a decreased pressure-pain threshold (PPT) (hypersensitivity). In previous studies using PPT measurement, pain sensitivity was detected in the shoulder and remote joints in patients with subacromial pain syndrome (SPS), which was considered as evidence of central sensitization. However, these studies did not show how pain sensitivity differs according to body segment in patients with SPS. Hypersensitivity that develops due to chronic shoulder pain would exacerbate the perception of pain caused by other musculoskeletal diseases or trauma. Therefore, it may be important for clinicians to determine how pain sensitivity varies by body segment in patients with SPS

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

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

Study Locations

  • Turkey
      • Adana, Turkey, 01100
        • Cukurova University

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

Yes

Sampling Method

Probability Sample

Study Population

Physical medicine and rehabilitation clinic

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.

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
Control
Healthy participants
Diagnostic test: Assessment of hypersensitivity
Assessment of pain hypersensitivity in body segments was performed using pressure pain measurement
Chronic subacromial pain
Patients with central sensitization associated with chronic pain syndrome
Diagnostic test: Assessment of hypersensitivity
Assessment of pain hypersensitivity in body segments was performed using pressure pain measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold (PPT) measurement
Time Frame: Baseline
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)
Time Frame: Baseline
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

Collaborators and Investigators

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

Sponsor

Cukurova University

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)

September 20, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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