NCT07269444

Brief Summary

Osteoarthritis (OA) is a degenerative joint disease characterized by the progressive degeneration of articular cartilage resulting from the interaction of genetic, metabolic, and biochemical factors and is often accompanied by secondary inflammation. This condition represents a pathological process involving the dynamic interaction of cartilage degradation and repair mechanisms affecting the cartilage, subchondral bone, and synovium. Osteoarthritis is the most common joint disease worldwide and represents one of the leading causes of physical disability. Pain is the most prominent symptom of osteoarthritis. It typically increases with activity and decreases with rest. As the disease progresses, pain may occur with minimal activity and can eventually be present at rest and during the night. The knee joint is a synovial joint formed between the femoral condyles and the tibia. Sensory innervation of the knee joint is provided by branches of the femoral, obturator, and sciatic nerves. Pain associated with knee osteoarthritis is a common clinical problem that can lead to functional limitation and reduced quality of life. In many patients with chronic knee pain due to osteoarthritis, pharmacological treatments and/or physical therapy may not provide sufficient analgesia. Knee arthroplasty is the most frequently used treatment option for advanced knee osteoarthritis; however, it may not be suitable for some patients because of comorbidities. Currently, one of the most commonly used interventional treatment methods for pain control in knee osteoarthritis is intra-articular steroid injection. This treatment reduces synovial inflammation and may slow disease progression. However, repeated steroid injections may provide only short-term pain relief and may also contribute to cartilage degeneration. In recent years, alternative interventional approaches for the management of osteoarthritis-related knee pain have gained increasing attention. The nerves responsible for knee joint pain originate from both the anterior and posterior aspects of the joint. The IPACK (infiltration between the popliteal artery and the capsule of the knee) block is a simple and practical technique performed under ultrasound guidance. Although it is primarily intended to block the posterior articular innervation of the knee, cadaveric studies suggest that the anterior genicular nerves may also be affected. Therefore, the IPACK block may serve as an alternative treatment option for providing additional analgesia in patients with advanced knee osteoarthritis. The aim of this study was to investigate the effects of an IPACK block combined with intra-articular steroid injection on pain scores in patients with chronic knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5 days

First QC Date

November 25, 2025

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1. Numeric Rating Scale (NRS-11): The NRS-11 is an 11-point numerical scale (9) that allows patients to rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever experienced). It was assessed three times: pre-treatment, 1 month a

    6 month

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):

    6 month

Study Arms (1)

Comparison of the Effectiveness of Ultrasonography-Guided Intra-Articular Steroid Injection and IPAC

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to a tertiary hospital in Istanbul, Turkey, with knee pain and diagnosed with stage 3-4 knee osteoarthritis based on clinical and radiological findings between January 2024 and September 2025 were included in the study. The procedure was performed on a single knee, and the contralateral knee was not treated.

You may qualify if:

  • Patients over 40 years of age
  • Diagnosed with primary knee osteoarthritis according to ACR (American College of Rheumatology) criteria based on clinical, radiological, and laboratory evaluations
  • Activity VAS score of 5 or higher despite previous medical and physical therapy
  • Patients with stage 3-4 knee osteoarthritis according to the Kellgren-Lawrence classification
  • Patients without motor or sensory loss on neurological examination
  • Patients who signed an informed consent form
  • Patients who have not undergone any interventional procedures on the knee within the last 6 months

You may not qualify if:

  • Patients with bleeding or coagulation disorders
  • Patients with sepsis or local infection at the intervention site
  • Patients with allergies to any of the medications to be used
  • Patients without study consent
  • Patients with secondary osteoarthritis
  • Patients who have undergone knee interventions in the last 6 months
  • Patients who have undergone knee surgery
  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Küçükçekmece, Istanbul, (507) 277-4773, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of pain medicine

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 8, 2025

Study Start

December 5, 2025

Primary Completion

December 10, 2025

Study Completion

December 23, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations