Clinical trial NCT06704386: Chronic Pain and Amputation: A Quality of Life Comparison
Official title: Life Beyond Pain and Loss: A Comperative Analysis of Quality of Life in Chronic Pain and Amputee Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain
Amputation
Keywords: Amputation
quality of life
chronic pain
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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?

Detailed description: Chronic pain is a common, complex, and distressing public health issue that significantly impacts both individuals and society, affecting more than 30% of the global population. Each year, 1 in 10 people develop chronic pain, making it one of the leading causes of disability worldwide. It is also one of the primary reasons patients seek medical care. The economic burden of chronic pain rivals that of cancer and cardiovascular diseases. Chronic pain is a multidimensional health problem, influencing every aspect of patients' lives. It contributes to loss of function and is accompanied by physical, emotional, cognitive, psychosocial, and motivational challenges. Additionally, it is associated with reduced activity levels, impaired functionality, and a significant decline in quality of life.

Amputation, on the other hand, is a major trauma that results in profound changes to body structure and function, substantially affecting an individual's quality of life, both socially and professionally. It creates barriers to reintegration into work and social life, limiting active participation in society. Amputation has far-reaching impacts on quality of life, including body image concerns, loss of a sense of integrity, decreased self-esteem, a distorted body image, feelings of emptiness and worthlessness, difficulties with social adjustment, reduced sexual activity, anxiety, depression, social discomfort, and challenges in relationships and marriage.

Health is defined as a state of complete physical, social, and spiritual well-being. Both chronic pain and amputation impair individuals' health status due to limitations in physical and social functioning, mental health challenges, pain, and reduced health-related quality of life. While numerous studies have explored the quality of life associated with each condition, no study has directly compared the quality of life between individuals with chronic pain and those who have undergone amputation.

The aim of this study is to compare the quality of life of individuals with chronic pain to that of amputees, providing valuable insights into the unique and overlapping challenges faced by these patient groups.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Short Form -36 (SF-36)
timeFrame: From November 14 to December 17
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University Adana Dr Turgut Noyan Research and Training Center
Study officials:
References: