Hip OsteoarthritisNCT05136248
Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis
A study testing intraarticular injection and peng block in people with Hip Osteoarthritis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip. Innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- intraarticular injection and peng block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2020to 20 Dec 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hip pain NRS > 4
- No pathologies in the laboratory and coagulation parameters
Who cannot join
- Rheumatological disease with hip involvement
- Systemic active infection
- Malignancy
- History of hip joint surgery
- History of traumatic hip injury
- Platelets values < 150.000 / µl
- History of bleeding disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: Comparison of Ultrasound Guided Intra-articular Steroid Injection and Pericapsular Nerve Group Block (PENG) in Patients With Chronic Hip Pain
The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip. Innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve. With pericapsular nerve group block (PENG), by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully provided for the hip joint. Intra-articular injection of corticosteroids; It is used as an alternative to surgical interventions because it reduces inflammation and short-term pain and is a minimally invasive method. The investigators aim to compare and report patients who underwent ultrasound-guided intra-articular steroid injection and PENG block in terms of post-procedural pain scores and patient satisfaction.
- Conditions
- Hip Osteoarthritis
- Being tested
- intraarticular injection, peng block
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarticular injectionProcedure or surgery
Ultrasound-guided intraarticular injection
peng blockProcedure or surgery
Ultrasound-guided PENG block
| Study group | Role | What they receive |
|---|---|---|
| intraarticular injection | Experimental | intra-articular steroid injection with the ultrasound guidance technique, Receives: Procedure: intraarticular injection |
| peng block | Active comparator | Ultrasound guided drug injection between to iliopubic eminentia and psoas tendon Receives: Procedure: peng block |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS) pain score
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: change from baseline to day 1, week 2, 4, 8 after the block
Secondary outcomes (1)
Quality of Life (WOMAC)
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain, stiffness, and physical function, validated to patients with hip or knee osteoarthritis
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start25 Apr 2020
- Primary completion20 Aug 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Guven Kose, Diskapi Teaching and Research Hospital
- Investigators
- selin guven kose, Principal investigator, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136248
- Sponsor's protocol ID
- 84/18
- Status last verified
- Apr 2023
- First submitted
- 30 Sep 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Intra-articular Steroid Injection and Pericapsular Nerve Group Block (PENG) in Patients With Chronic Hip Pain
- ClinicalTrials.gov ID
- NCT05136248
- Acronym / sponsor ID
- 84/18
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 29 Nov 2021 (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.
The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip. Innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve. With pericapsular nerve group block (PENG), by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully provided for the hip joint. Intra-articular injection of corticosteroids; It is used as an alternative to surgical interventions because it reduces inflammation and short-term pain and is a minimally invasive method. The investigators aim to compare and report patients who underwent ultrasound-guided intra-articular steroid injection and PENG block in terms of post-procedural pain scores and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraarticular injection | Experimental | Procedure: intraarticular injectionintra-articular steroid injection with the ultrasound guidance technique, |
| peng block | Active comparator | Procedure: peng blockUltrasound guided drug injection between to iliopubic eminentia and psoas tendon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hip pain NRS > 4
- No pathologies in the laboratory and coagulation parameters
Key exclusion criteria (7 listed)
- Rheumatological disease with hip involvement
- Systemic active infection
- Malignancy
- History of hip joint surgery
- History of traumatic hip injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraarticular injectionUltrasound-guided intraarticular injection | Procedure or surgery | intraarticular injection |
| peng blockUltrasound-guided PENG block | Procedure or surgery | peng block |
Primary outcome
numerical rating scale (NRS) pain score
Time frame: change from baseline to day 1, week 2, 4, 8 after the block
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
1 secondary outcome
Quality of Life (WOMAC)
Time frame: baseline to 8 weeks
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 4 Apr 2023.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
selin guven kose principal investigator
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraarticular injection and peng block in people with Hip Osteoarthritis, run by Diskapi Teaching 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 2 inclusion and 7 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 4 Apr 2023. 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?
numerical rating scale (NRS) pain score (time frame: change from baseline to day 1, week 2, 4, 8 after the block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.