Chronic PainNCT06704386
Chronic Pain and Amputation: A Quality of Life Comparison
An observational study of Chronic Pain and Amputation, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Amputation
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic pain and amputations will be recruited from the outpatient clinic of Physical Medicine and Rehabilitation Department
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Adana Dr Turgut Noyan Research and Training Center
Adana, 01200
About this study
Official title: Life Beyond Pain and Loss: A Comperative Analysis of Quality of Life in Chronic Pain and Amputee Patients
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?
Read the 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.
- Conditions
- Chronic Pain, Amputation
- Keywords
- Amputation, quality of life, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From November 14 to December 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Feb 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Gul Gulec, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704386
- Sponsor's protocol ID
- 24/191
- Status last verified
- May 2025
- First submitted
- 7 Nov 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Beyond Pain and Loss: A Comperative Analysis of Quality of Life in Chronic Pain and Amputee Patients
- ClinicalTrials.gov ID
- NCT06704386
- Acronym / sponsor ID
- 24/191
- Conditions
- Chronic Pain, Amputation
- Keywords
- Amputation, quality of life, chronic pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain and amputations will be recruited from the outpatient clinic of Physical Medicine and Rehabilitation Department
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short Form -36 (SF-36)
Time frame: From November 14 to December 17
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Amputation, run by Kastamonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form -36 (SF-36) (time frame: From November 14 to December 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.