NCT05844319

Brief Summary

In this study, it was aimed to investigate the effect of pain management education in individuals with knee osteoarthritis with chronic pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

April 25, 2023

Last Update Submit

May 4, 2023

Conditions

OsteoarthritisKnee OsteoarthritisPain, Chronic

Keywords

OsteoarthritisPain ManagementActivities of Daily LivingQuality of LifeTele-education

Outcome Measures

Primary Outcomes (1)

  • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    We will use the Knee Injury and Osteoarthritis Outcome Score (KOOS) in order not to exceed the pain and daily life span of our patients. It is a scale that evaluates the functional status and groups related to knee injuries and knee osteoarthritis. Other definition of pain has 5 subgroups, including functional status related to daily life span, functional status in sports and leisure activities, and sequence-related quality of life. It consists of 42 questions lasting approximately 10 minutes. Each subscale is scored between 0-100. 0 indicates serious problem, 100 indicates no problem. A score of 10 and above indicates that it changes clinically.

    on the first day and eighth week change

Secondary Outcomes (2)

  • The McGill Pain Questionnaire

    on the first day and eighth week change

  • Short Form-12

    on the first day and eighth week change

Study Arms (1)

intervention

EXPERIMENTAL

Following the completion of the evaluations of the cases, the following 6-step program will be applied to cope with the pain: 1. Informative education about the disease 2. Teaching relaxation positions for pain management 3. Relaxation exercises with breathing exercises 4. Training on ergonomic approaches in daily life (correct sitting, lying, working, carrying, etc.) 5. Education of principles of joint protection 6. Creating and training a personalized physical activity and exercise plan

Other: tele-education

Interventions

tele-educationOTHER

The treatment of the patients will be carried out by tele-education method.

intervention

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR)
  • Be between 45 and 75 years old
  • Stage 2-3 according to Kellgren Lawrence (K-L) in the radiological examination

You may not qualify if:

  • Having active synovitis
  • Receiving physical therapy in the last 6 months
  • People with neurological problems that affect walking
  • Those with arthritis in the ankle and hip joint
  • Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise.
  • Have had surgery on the lower extremity in the past
  • Intra-articular steroid injections in the last 6 months
  • Use of psychoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tugba Civi Karaaslan

Istanbul, Buyukcekmece, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, KneeChronic PainAgnosia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • MEHMET YAZGAN, BSc

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

  • MELIKE KARAVUL, BSc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • HUSEYIN BAYBAS, BSc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • ELA TARAKCI, Prof

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Central Study Contacts

TUGBA CIVI KARAASLAN, PhD

CONTACT

05343855606tugba.civi@istanbul.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

May 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)