Factors Affecting Quality of Life in Patient With Chronic Musculoskeletal Pain

March 31, 2023 updated by: Tugba Sahbaz, Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • kanuni Sultan suleyman Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Aged between 18 and 65 years old
  • Clinical diagnosis of spondilosis and gonarthrosis-
  • Must not be surgical indication

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline
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
baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAEK/2021.11.306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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