Chronic Pain and Amputation: A Quality of Life Comparison

NCT06704386 | Active Not Recruiting

• 1 other identifier: 24/191
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational, cross-sectional study is to investigate and compare the impact of chronic pain and amputation on patients' quality of life. By excluding individuals with conditions that might influence quality of life, the study seeks to provide insights into how these two conditions affect physical and emotional well-being. Statistical methods will be employed to analyze the data. The primary research questions are as follows: Is the quality of life of individuals with chronic pain lower than that of those with an amputation? Is the quality of life of individuals with chronic pain higher than that of those with an amputation? Is the quality of life of individuals with chronic pain similar to that of those with an amputation?

Conditions

Chronic Pain; Amputation

Keywords

Amputation; quality of life; chronic pain

Outcome Measures

Primary Outcomes (1)

• Short Form -36 (SF-36)

  The SF-36 is one of the most widely used generic tools for measuring quality of life.This scale evaluates eight health dimensions across 36 items: physical function, role limitations (due to physical and emotional problems), social function, mental health, vitality (energy), pain, and general health perception. The SF-36 offers several advantages, including its ability to assess both the positive and negative aspects of a health condition in just five minutes.It also demonstrates superior sensitivity in detecting subtle changes in disability compared to other scales. Instead of providing a single score, the SF-36 generates separate scores for each subscale, ranging from 0 to 100. A score of 100 indicates excellent health, while a score of 0 reflects poor health. It has been validated and found reliable in Turkish and is recommended for use across all physical disease groups to assess quality of life comprehensively.

  From November 14 to December 17

Study Arms (2)

Patients with amputations

Patients with amputation who are over 18 years of age, have sufficient Turkish reading and comprehension skills, and have experienced at least one year since the amputation, excluding those with congenital amputations or chronic pain.

Patients with Chronic Pain

Patients with chronic pain who are over 18 years of age, have experienced pain for more than 3 months, and possess sufficient Turkish reading and comprehension skills.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain and amputations will be recruited from the outpatient clinic of Physical Medicine and Rehabilitation Department

You may qualify if:

• Being 18 years old or older
• Having adequate Turkish reading and understanding skills
• Having pain for more than 3 months (for patients with chronic pain)
• At least 1 year having passed since the amputation (for patients with amputatiton)

You may not qualify if:

• Having additional diseases such as stroke, multiple sclerosis, arthrosis, and psychiatric disorders, which could limit their physical and emotional status, so the quality of life
• Pregnancy Experiencing pain due to malignancy (for patients with chronic pain)
• Congenital amputation and chronic pain (for patients with amputatition)

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Baskent University Adana Dr Turgut Noyan Research and Training Center

Adana, 01200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 26, 2024
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)