Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06336278
Other study ID # 19/03/2024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 1, 2023

Study information

Verified date April 2024
Source Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression. Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.


Description:

Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria for knee osteoarthritis group: - Being a healthy volunteer between the ages of 45-75 - Being diagnosed with knee osteoarthritis according to ACR diagnostic criteria - Knee pain for at least 6 months - Kellgren-Lawrence 1, 2 or 3 radiologic grade of knee OA - Body mass index below 35 Exclusion Criteria for knee osteoarthritis group: - Presence of chronic widespread painful diseases other than osteoarthritis (fibromyalgia syndrome etc.), rheumatologic disease, peripheral neuropathy - Presence of uncontrolled systemic disease - Cooperation limitation or cognitive impairment - Active arthritis in the knee joint to be evaluated - Presence of prosthesis in the knees - Pain in the forearm - Body mass index of 35 and above

Study Design


Intervention

Diagnostic Test:
Pressure Algometer
Pressure algometer is used to detect pain pressure treshold.

Locations

Country Name City State
Turkey Zonguldak Bulent Ecevit Universitiy Zonguldak

Sponsors (1)

Lead Sponsor Collaborator
Selda Sarikaya

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Pressure Treshold Algometer was used to detect pressure pain threshold. Higher scores mean better outcomes. Day 1
Primary Central Sensitization Central Sensitization Inventory was used to evaluate central sensitization. Minimum value is 0 , maximum value is 100. Higher values means worse outcomes. Day 1
Primary Kinesiophobia The presence of kinesiophobia was assessed with Tampa Scale af Kinesiophobia. Minimum value is 17 , maximum value is 68. Higher values means worse outcomes. Day 1
Secondary Pain Catastrophizing Pain Catastrophizing Scale was used to assess chronic pain related symptoms. Minimum value is 0 , maximum value is 52. Higher values means worse outcomes. Day 1
Secondary Depression Beck Depression Inventory was used to assess depression. Minimum value is 0 , maximum value is 63. Higher values means worse outcomes. Day 1
Secondary Visuel Analog Scala Visuel Analog Scala was used to assess pain intensity. Patients' pain (0=no pain, 10=intolerable pain) on a 100 mm horizontal line. The marked value was recorded in millimeters. Day 1
Secondary Western Ontario and McMaster Universitesies Osteoarthritis Index Pain and functional status of the patients included in our study assessment was performed using this index, consists of a total of three subscales and 24 questions, each question is scored between 0 and 4 (0=none, 4=very severe). Minimum value is 0, maximum value is 100. Higher scores indicate an increase in pain and stiffness and a decline in physical function. Day 1
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Recruiting NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A