NCT05298566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

February 3, 2022

Last Update Submit

March 31, 2023

Conditions

Quality of LifeChronic Musculoskeletal DiseaseChronic Pain

Keywords

quality of lifedisabiltyChronic musculoskeletal pain

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kanuni Sultan suleyman Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 31979306BACKGROUND

  • Agnus 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.

    PMID: 35003902BACKGROUND

  • Koçyiğit H AÖ FG. Kısa Form-36'nın Türkçe versiyonunun güvenlirliği ve geçerliliği. İlaç ve Tedavi Dergisi (12):102-6.

    BACKGROUND

  • 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.

    PMID: 20169459BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tugba Sahbaz, MD

    Kanuni Sultan Suleyman Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2022

First Posted

March 28, 2022

Study Start

March 27, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)