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Clinical Trials/NCT04219072
NCT04219072
Completed
Not Applicable

Clinical Classification of Pain in Breast Cancer Survivors: Nociceptive, Neuropathic or Nociplastic Pain

Kutahya Health Sciences University1 site in 1 country96 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Kutahya Health Sciences University
Enrollment
96
Locations
1
Primary Endpoint
Central Sensitization Inventory
Status
Completed
Last Updated
last year

Overview

Brief Summary

Breast cancer is the most common malignancy in women worldwide according to International Agency for Research on Cancer. Unfortunately, cancer survivors often face long-term symptoms that occur or persist after completion of treatment. In addition to fatigue, pain is the most common persistent symptom after cancer and cancer treatment. The diagnosis and treatment of pain in cancer survivors is not clear for many physicians. A mechanism-based classification of pain in cancer survivors might be a critical step for clinical reasoning, especially for discrimination of different pain types. The primary aim of this study is to determine the prevalence of the predominant type of pain in Turkish breast cancer survivors using a recent published clinical algorithm.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
October 28, 2023
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Kutahya Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Ismail Saracoglu

Principal Investigator

Kutahya Health Sciences University

Eligibility Criteria

Inclusion Criteria

  • diagnosed with histologically confirmed invasive or non-invasive primary breast cancer
  • completed remission and their primary treatment at least 3 months prior to study participation
  • experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale

Exclusion Criteria

  • patients affected by other chronic disease,
  • severe psychological disorders
  • active metastases

Outcomes

Primary Outcomes

Central Sensitization Inventory

Time Frame: 10 minute

The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain. The CSI consists 25 items exploring emotional and somatic disorders associated with CS. Each response is scored from 0 to 4, yielding a total score of 0 to 100. A score of 40 or higher on the CSI means the presence of nociplastic pain.

Short Form 36

Time Frame: 10 minute

The Short Form-36 (SF-36) is widely used to measurement of health related quality of life (HRQoL) questionnaire. SF-36 is a 36-item generic self-administered instrument consisting of 8 subscales related to various aspects of HRQoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The 8 subscales are scored from 0 to 100, with higher scores indicating better health status.

Numeric Pain Rating Scale

Time Frame: 1 minute

The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Margolis Pain Diagram

Time Frame: 5 minute

The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours

Secondary Outcomes

  • Quantitative sensory test(10 minute)

Study Sites (1)

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