The Effectiveness of BETY in Knee Osteoarthritis With Intra-Articular Injections

NCT07496203 | Recruiting

• 1 other identifier: FTREK25_143
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is the most common condition in middle-aged and elderly populations; it causes pain and physical disability and is characterized by cartilage degeneration, changes in bone tissue, inflammation of the synovial membrane, and an increased inflammatory response. Because pain and depression often co-occur in individuals diagnosed with OA, the concepts of disability and health-related quality of life caused by the disease have become more decisive than radiological joint damage. The chronic nature of the disease, like other chronic conditions, encompasses a range of biopsychosocial impacts, including pain, fatigue, sleep disturbances, functional loss, anxiety, depression, and social isolation. This complex structure is accompanied by a pattern in which inflammatory processes are triggered. Recently, intra-articular injections (such as Platelet-Rich Plasma Therapy (PRP), Hyaluronic Acid (HA), PRP+HA combinations, Corticosteroids, Prolotherapy, and Stem Cells) have been accepted as a treatment for OA. Regarding the mechanism of these intra-articular injections, it has been reported that a combination of various anabolic and anti-inflammatory cytokines may treat inflammation associated with the early stages of OA. It has been demonstrated that, through the effects of various growth factors, these treatments have a positive impact on chondrogenesis and mesenchymal stem cell proliferation by increasing anti-inflammatory mediators and reducing pro-inflammatory mediators. Bilişsel Egzersiz Terapi Yaklaşımı - BETY (Cognitive Exercise Therapy Approach in english) is an exercise approach based on the biopsychosocial model. BETY consists of innovations in function-oriented body stabilization exercises (FoGSE), chronic pain management (BETY-Nociplastic Pain Management (BETY-NPM)), emotion-mood information management (dance therapy-authentic movement), and sexuality information management. The aim of this study is to investigate the effectiveness of BETY, which is often initiated following intra-articular injections-a treatment frequently chosen for individuals diagnosed with knee osteoarthritis (OA).

Conditions

Osteo Arthritis of the Knee; Pain; Pain Management; Exercise

Outcome Measures

Primary Outcomes (2)

• BETY-BQ

  The BETY-BQ 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.

  6 months

• Muscle Strength

  Muscle strength will be assessed using the Biodex System 3 Pro® isokinetic device (Biodex Medical Systems Inc., Shirley, NY, USA). Before the first assessment, participants will be recruited to a familiarization session. Each assessment will be preceded by a 10-minute warm-up walk and participants will perform knee flexor and extensor maximal concentric isokinetic muscle strength tests at angular velocities of 180°/s (10 repetitions) and 60°/s (5 repetitions) with a 30-second rest interval. Peak torque (PT) and average power (AP) will be recorded in Newtons (Nm) and watts (W) per meter.

  6 months

Secondary Outcomes (13)

• Health Asessement Questionnaire (HAQ)

  6 mounths

• Hospital Anxiety Depression Scale (HADS)

  6 mounths

• Short Form - 36

  6 months

• WOMAC Osteoarthritis Index

  6 mounths

• Pain Catastrophizing Scale

  6 mounths

Study Arms (3)

BETY Group

ACTIVE COMPARATOR

BETY Exercise Group

Other: BETY

Control Group

ACTIVE COMPARATOR

Control group

Other: BETY

Traditional Exercise Group

ACTIVE COMPARATOR

Traditional Exercise Group

Other: BETY

Interventions

BETY OTHER

Participants in this group will follow a traditional exercise program consisting of active range-of-motion exercises for the knee joint, isometric muscle strengthening, and stretching exercises targeting the lower extremity muscle groups.

BETY Group; Control Group; Traditional Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• having received an intra-articular injection in the knee within the past month
• 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

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Samanpazarı, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Study Officials

• Edibe Ünal

  Hacettepe University

  STUDY CHAIR

Central Study Contacts

Aysima Barlak, PT, MSc

CONTACT

+903123052525; fztaysimabarlak@gmail.com

Edibe Ünal, PT, Prof

CONTACT

03123052525; edibeunal@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: January 2, 2026
• Primary Completion: March 20, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)