Quality of LifeNCT05298566
Factors Affecting Quality of Life in Patient With Chronic Musculoskeletal Pain
An observational study of Quality of Life and Chronic Musculoskeletal Disease, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study included patients who applied to the physical therapy and rehabilitation outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and met the criteria for participation in the study. Demografik datas, pain , Functional Limitations and Quality of Life wa evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life, Chronic Musculoskeletal Disease, Chronic Pain
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients who applied to the physical therapy and rehabilitation outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and meeting the criteria for participation in the study will be included in our study.
Who may be able to join
- Aged between 18 and 65 years old
- Clinical diagnosis of spondilosis and gonarthrosis-
- Must not be surgical indication
Who cannot join
- History of knee or back surgery
- Detection of muscle weakness on physical examination
- Presence of additional neurological disease that will affect the patient's mobilization and cognitive level
- Presence of Cognitive impairment
- Presence of Chronic pain of nonmusculoskeletal origin (gynocological, retroperitoneal, abdominal)
- Being treated for depression
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
kanuni Sultan suleyman Research Hospital
Istanbul
About this study
This study included patients who applied to the physical therapy and rehabilitation outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and met the criteria for participation in the study.
Demografik datas, pain , Functional Limitations and Quality of Life wa evaluated.
Read the detailed description
When treating diseases, clinicians traditionally aim for pain reduction and functional recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial support required to improve the general health perception of patients is becoming increasingly important. In clinical practice, it is essential to evaluate the quality of life and general well-being and to evaluate the patient completely biopsychosocially . Determining the factors affecting the quality of life is important in terms of contributing to the rehabilitation processes and treatment plans of CMP patients. In this direction, our study aims to examine the factors affecting the quality of life.
When treating diseases, clinicians traditionally aim for pain reduction and functional recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial support required to improve the general health perception of patients is becoming increasingly important. In clinical practice, it is essential to evaluate the quality of life and general well-being and to evaluate the patient completely biopsychosocially . Determining the factors affecting the quality of life is important in terms of contributing to the rehabilitation processes and treatment plans of CMP patients. In this direction, our study aims to examine the factors affecting the quality of life.
- Keywords
- quality of life, disabilty, Chronic musculoskeletal pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
The severity of rest pain and activity pain experienced by the patients in the last 1 week will be evaluated by VAS, which is a numeric rating scale. The highest pain intensity is 10, o no pain, 5 will be scored as moderate pain. Higher scores mean more pain intensity
Measured: Baseline
Functioal Limitation
Roland Morris questionare (RMQ) will be used for disability assessment in patients with chronic low back pain.Roland Morris questionare evaluates functional limitation due to low back pain. The total maximum score is 24. It includes a total of 24 items questioning patients' mobility, self-care and sleep status.
Disability in patients with knee osteoarthritis will be evaluated with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).WOMAC; It is a 24-item scale that examines three dimensions: pain, stiffness and physical function. Higher scores mean more disability
Measured: baseline
Health-related quality of life
The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start27 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Sahbaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Tugba Sahbaz, MD, Study director, Kanuni Sultan Suleyman Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298566
- Sponsor's protocol ID
- KAEK/2021.11.306
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeong H, Lee Y. Sex-Based Differences in the Quality of Life of Elderly Koreans with Chronic Musculoskeletal Pain. Int J Environ Res Public Health. 2020 Jan 23;17(3):743. doi: 10.3390/ijerph17030743.
PubMed 31979306Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
PubMed 35003902Koçyiğit H AÖ FG. Kısa Form-36'nın Türkçe versiyonunun güvenlirliği ve geçerliliği. İlaç ve Tedavi Dergisi (12):102-6.
Basaran S, Guzel R, Seydaoglu G, Guler-Uysal F. Validity, reliability, and comparison of the WOMAC osteoarthritis index and Lequesne algofunctional index in Turkish patients with hip or knee osteoarthritis. Clin Rheumatol. 2010 Jul;29(7):749-56. doi: 10.1007/s10067-010-1398-2. Epub 2010 Feb 19.
PubMed 20169459
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Quality of Life in Patient With Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05298566
- Acronym / sponsor ID
- KAEK/2021.11.306
- Keywords
- quality of life, disabilty, Chronic musculoskeletal pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Mar 2022 (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.
This study included patients who applied to the physical therapy and rehabilitation outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and met the criteria for participation in the study.
Demografik datas, pain , Functional Limitations and Quality of Life wa evaluated.
Detailed description
When treating diseases, clinicians traditionally aim for pain reduction and functional recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial support required to improve the general health perception of patients is becoming increasingly important. In clinical practice, it is essential to evaluate the quality of life and general well-being and to evaluate the patient completely biopsychosocially . Determining the factors affecting the quality of life is important in terms of contributing to the rehabilitation processes and treatment plans of CMP patients. In this direction, our study aims to examine the factors affecting the quality of life.
When treating diseases, clinicians traditionally aim for pain reduction and functional recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial support required to improve the general health perception of patients is becoming increasingly important. In clinical practice, it is essential to evaluate the quality of life and general well-being and to evaluate the patient completely biopsychosocially . Determining the factors affecting the quality of life is important in terms of contributing to the rehabilitation processes and treatment plans of CMP patients. In this direction, our study aims to examine the factors affecting the quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who applied to the physical therapy and rehabilitation outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and meeting the criteria for participation in the study will be included in our study.
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years old
- Clinical diagnosis of spondilosis and gonarthrosis-
- Must not be surgical indication
Key exclusion criteria (6 listed)
- History of knee or back surgery
- Detection of muscle weakness on physical examination
- Presence of additional neurological disease that will affect the patient's mobilization and cognitive level
- Presence of Cognitive impairment
- Presence of Chronic pain of nonmusculoskeletal origin (gynocological, retroperitoneal, abdominal)
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
Pain Severity
Time frame: Baseline
The severity of rest pain and activity pain experienced by the patients in the last 1 week will be evaluated by VAS, which is a numeric rating scale. The highest pain intensity is 10, o no pain, 5 will be scored as moderate pain. Higher scores mean more pain intensity
Functioal Limitation
Time frame: baseline
Roland Morris questionare (RMQ) will be used for disability assessment in patients with chronic low back pain.Roland Morris questionare evaluates functional limitation due to low back pain. The total maximum score is 24. It includes a total of 24 items questioning patients' mobility, self-care and sleep status. Disability in patients with knee osteoarthritis will be evaluated with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).WOMAC; It is a 24-item scale that examines three dimensions: pain, stiffness and physical function. Higher scores mean more disability
Health-related quality of life
Time frame: Baseline
The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Background: PubMed 31979306Jeong H, Lee Y. Sex-Based Differences in the Quality of Life of Elderly Koreans with Chronic Musculoskeletal Pain. Int J Environ Res Public Health. 2020 Jan 23;17(3):743. doi: 10.3390/ijerph17030743.
- Background: PubMed 35003902Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
- BackgroundKoçyiğit H AÖ FG. Kısa Form-36'nın Türkçe versiyonunun güvenlirliği ve geçerliliği. İlaç ve Tedavi Dergisi (12):102-6.
- Background: PubMed 20169459Basaran S, Guzel R, Seydaoglu G, Guler-Uysal F. Validity, reliability, and comparison of the WOMAC osteoarthritis index and Lequesne algofunctional index in Turkish patients with hip or knee osteoarthritis. Clin Rheumatol. 2010 Jul;29(7):749-56. doi: 10.1007/s10067-010-1398-2. Epub 2010 Feb 19.
- 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.
Tugba Sahbaz, MD study director
Kanuni Sultan Suleyman Research Hospital
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 Quality of Life and Chronic Musculoskeletal Disease, run by Kanuni Sultan Suleyman Training and Research Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Severity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298566, which also lists 4 linked publications.
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 4 Apr 2023.