Knee Osteoarthritis (Knee OA)NCT07269444
Efficacy of IPACK Block Combined With Intra-articular Steroid Injection in Advanced Knee Osteoarthritis: A Retrospective Cohort Study
An observational study of Knee Osteoarthritis (Knee OA) and IPACK Block Multimodal Analgesia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis (Knee OA), IPACK Block Multimodal Analgesia, Intraarticular Injection
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 23 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Küçükçekmece, Istanbul, (507) 277-4773
About this study
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.
Read more
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.
Read the detailed description
Patients presenting to a tertiary hospital in Istanbul, Turkey, between January 2024 and September 2025 with knee pain and diagnosed with stage 3-4 knee osteoarthritis based on clinical and radiological findings were scheduled for the procedure. The procedure was performed on only one knee, and the contralateral knee was not treated.
On the morning of the procedure, patients' NRS-11 and WOMAC scores were recorded. After being taken to the operating room, patients were placed in the supine position. Electrocardiography, pulse oximetry, and non-invasive blood pressure monitoring were performed. Intravenous access was established. The painful knee area was prepared and draped in a sterile manner using a povidone-iodine-based solution. Ultrasonography (US) was used to visualize the knee joint and surrounding structures.
In patients undergoing intra-articular steroid injection (IASI), a 22-gauge, 90-mm needle was advanced from the suprapatellar region into the joint space under ultrasound guidance. After puncturing the joint capsule, a mixture of 4 ml of 1% lidocaine and 40 mg of triamcinolone acetonide was injected into the joint.
Patients undergoing IASI + IPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block were also placed in the supine position with standard monitoring and sterile preparation. First, the IASI procedure was performed as described above. Then, a pillow was placed under the knee to achieve approximately 30° of flexion. Using an ultrasound-guided medial approach, the probe was positioned approximately 2-3 cm above the patella level, starting from the distal medial femoral epicondyle. Subsequently, a 22-gauge, 90-mm needle was advanced to the space between the posterior joint capsule and the popliteal vessels at the level where the femoral condyles end and the femoral shaft begins. A total of 15 mL of a mixture containing 0.25% bupivacaine and 4 mg dexamethasone was injected.
After the procedure, patients were observed in the inpatient ward for at least 2 hours to monitor for potential adverse effects. One week after the injection, all patients were provided with an exercise booklet to guide their home-based rehabilitation program.
Patients were advised to use 500 mg paracetamol (up to four tablets per day) as needed for pain control. They were instructed not to take any analgesics on the day of follow-up assessments, as this could affect clinical outcome measures. Paracetamol consumption was recorded at the end of the 1st and 6th months. NRS-11 and WOMAC scores were also recorded at the 1st and 6th months during outpatient clinic visits.
- Conditions
- Knee Osteoarthritis (Knee OA), IPACK Block Multimodal Analgesia, Intraarticular Injection, Ultrasound Guided Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of the Effectiveness of Ultrasonography-Guided Intra-Articular Steroid Injection and IPAC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Secondary outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):
It is a standardized questionnaire widely used by healthcare professionals to assess the condition of patients with knee and hip osteoarthritis, including pain, stiffness, and physical function of the joints. It was developed in 1982 by Western Ontario and McMaster Universities. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC consists of five items for pain (score range 0-20), two items for stiffness (score range 0-8), and 17 items for functional limitations (score range 0-68).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start5 Dec 2025
- Primary completion10 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Responsible party
- Principal investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269444
- Sponsor's protocol ID
- knee osteoarthritis
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Altun HI, Gozukizil ST. Efficacy of IPACK block combined with intra-articular steroid injection in advanced knee osteoarthritis: a retrospective cohort study. BMC Anesthesiol. 2026 May 7;26(1):380. doi: 10.1186/s12871-026-03896-8.
PubMed 42098611
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of IPACK Block Combined With Intra-articular Steroid Injection in Advanced Knee Osteoarthritis: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07269444
- Acronym / sponsor ID
- knee osteoarthritis
- Conditions
- Knee Osteoarthritis (Knee OA), IPACK Block Multimodal Analgesia, Intraarticular Injection, Ultrasound Guided Injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients presenting to a tertiary hospital in Istanbul, Turkey, between January 2024 and September 2025 with knee pain and diagnosed with stage 3-4 knee osteoarthritis based on clinical and radiological findings were scheduled for the procedure. The procedure was performed on only one knee, and the contralateral knee was not treated.
On the morning of the procedure, patients' NRS-11 and WOMAC scores were recorded. After being taken to the operating room, patients were placed in the supine position. Electrocardiography, pulse oximetry, and non-invasive blood pressure monitoring were performed. Intravenous access was established. The painful knee area was prepared and draped in a sterile manner using a povidone-iodine-based solution. Ultrasonography (US) was used to visualize the knee joint and surrounding structures.
In patients undergoing intra-articular steroid injection (IASI), a 22-gauge, 90-mm needle was advanced from the suprapatellar region into the joint space under ultrasound guidance. After puncturing the joint capsule, a mixture of 4 ml of 1% lidocaine and 40 mg of triamcinolone acetonide was injected into the joint.
Patients undergoing IASI + IPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block were also placed in the supine position with standard monitoring and sterile preparation. First, the IASI procedure was performed as described above. Then, a pillow was placed under the knee to achieve approximately 30° of flexion. Using an ultrasound-guided medial approach, the probe was positioned approximately 2-3 cm above the patella level, starting from the distal medial femoral epicondyle. Subsequently, a 22-gauge, 90-mm needle was advanced to the space between the posterior joint capsule and the popliteal vessels at the level where the femoral condyles end and the femoral shaft begins. A total of 15 mL of a mixture containing 0.25% bupivacaine and 4 mg dexamethasone was injected.
After the procedure, patients were observed in the inpatient ward for at least 2 hours to monitor for potential adverse effects. One week after the injection, all patients were provided with an exercise booklet to guide their home-based rehabilitation program.
Patients were advised to use 500 mg paracetamol (up to four tablets per day) as needed for pain control. They were instructed not to take any analgesics on the day of follow-up assessments, as this could affect clinical outcome measures. Paracetamol consumption was recorded at the end of the 1st and 6th months. NRS-11 and WOMAC scores were also recorded at the 1st and 6th months during outpatient clinic visits.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of the Effectiveness of Ultrasonography-Guided Intra-Articular Steroid Injection and IPAC | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 6 month
1 secondary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 42098611Altun HI, Gozukizil ST. Efficacy of IPACK block combined with intra-articular steroid injection in advanced knee osteoarthritis: a retrospective cohort study. BMC Anesthesiol. 2026 May 7;26(1):380. doi: 10.1186/s12871-026-03896-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis (Knee OA) and IPACK Block Multimodal Analgesia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07269444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.