Investigation of Biopsychosocial Characteristics of Individuals with Knee Osteoarthritis

NCT06591715 | Not Yet Recruiting

• 1 other identifier: SBA 24/862
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Since pain and depression are observed together in rheumatic diseases, the concept of limitation caused by the disease and health-related quality of life becomes more determinant than radiological joint damage. Sleep problems observed in OA also increase the level of depression findings and difficulty in movement. The chronic nature of the disease includes issues such as pain, fatigue, sleep problems, loss of function, anxiety, depression, and social isolation, together as in other chronic diseases. This complex structure accompanies a picture in which inflammatory processes are triggered. When the literature is examined, the necessity of evaluation and methods including all these biopsychosocial characteristics of chronic diseases with multifaceted symptoms is emphasized. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasized that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide a holistic assessment of chronic diseases. When the literature, including individuals diagnosed with osteoarthritis, is analyzed, the inadequacy of the studies providing biopsychosocial evaluation draws attention.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

osteoarthritis; biopsychosocial; depression; social isolation; pain; sleep; functionality

Outcome Measures

Primary Outcomes (1)

• Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

  The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.

  3 mounths

Secondary Outcomes (14)

• Health Asessement Questionnaire (HAQ)

  3 mounths

• Hospital Anxiety Depression Scale (HADS)

  3 mounths

• Short Form - 36

  3 mounths

• WOMAC Osteoarthritis Index

  3 mounths

• Pain Catastrophizing Scale

  3 mounths

Interventions

Home exercise program OTHER

The home exercise program routinely given to individuals with knee OA in addition to their medical treatment will consist of exercises routinely used in the BETY innovation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of individuals who come to the university hospital for routine controls.

You may qualify if:

• Diagnosis of knee osteoarthritis according to ACR knee osteoarthritis diagnostic criteria
• Being in stage 2 or 3 according to Kellgren-Lawrence radiological staging criteria
• To be 18 years of age or older
• Being a reader-writer
• Having read and signed the informed consent

You may not qualify if:

• History of major psychiatric illness
• Having malignant disease
• Having chronic infectious or other rheumatologic diseases
• Serious knee trauma or surgical operation in the last 6 months
• Having collagen tissue disease
• History of peripheral vascular disease or neuropathy
• Being in stage 4 according to Kellgren Lawrence radiologic staging criteria
• To have received a physiotherapy program for the relevant knee in the last 3 months

Sponsors & Collaborators

• Aysima Barlak: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Depression; Social Isolation; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavioral Symptoms; Behavior; Social Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aysima Barlak, Licence

CONTACT

5412311754; fztasyimabarlak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 9, 2027
• Study Completion (Estimated): September 9, 2027
• Last Updated: February 12, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)