Image-Guided Intra-Articular Versus Periarticular Injection in Sacroiliac Joint Pain
Image-Guided Intra-Articular Versus Periarticular Injection in Sacroiliac Joint Pain: A Comparative Study of Early Pain Outcomes
Sacroiliac joint (SIJ) pain is a common cause of chronic low back pain that can arise from within the joint itself or from the surrounding ligaments and supporting soft tissues. Image-guided injections using corticosteroids and local anesthetics are widely used to treat SIJ pain when physical therapy or medications fail. However, it remains uncertain whether administering the injection directly inside the joint space (intra-articular) or into the surrounding posterior ligaments (periarticular) provides greater early pain relief and functional recovery.
The primary purpose of this clinical trial is to compare the efficacy, safety, and functional outcomes of fluoroscopy-guided intra-articular versus periarticular injections in adult patients with chronic sacroiliac joint pain.
Participants are randomly assigned in a 1:1 ratio to receive one of two fluoroscopy-guided procedures:
- Intra-Articular Injection Group: Participants receive an injection of methylprednisolone acetate and bupivacaine delivered directly into the synovial space of the sacroiliac joint under fluoroscopic guidance, confirmed with radiographic contrast.
- Periarticular Injection Group: Participants receive an injection of methylprednisolone acetate and bupivacaine deposited along the posterior sacroiliac ligament complex and outer capsule under fluoroscopic guidance.
All participants are followed for 8 weeks after the procedure. Changes in pain intensity are tracked using the Numeric Rating Scale (NRS) at baseline, 2 weeks, 4 weeks, and 8 weeks. Physical function and daily activity impairment are measured using the Oswestry Disability Index (ODI) at baseline, 4 weeks, and 8 weeks. Patient global improvement, side effects, and rescue pain medication consumption will also be monitored throughout the study period.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adult patients aged 18 to 70 years
- Clinical diagnosis of sacroiliac joint (SIJ) pain confirmed by at least 3 positive provocation tests out of 5 (FABER, Gaenslen's, thigh thrust, compression, or distraction tests)
- Chronic SIJ pain with a symptom duration of at least 3 months
- Pain intensity score of at least 4 out of 10 on the Numeric Rating Scale (NRS ≥ 4/10) at enrollment
- Failure of conservative management (physiotherapy and/or NSAIDs for at least 6 weeks)
- Willingness and ability to provide written informed consent
Exclusion Criteria:
- Known coagulopathy or current anticoagulant therapy that cannot be safely bridged
- Active local infection at the injection site or systemic infection
- Known hypersensitivity or allergy to corticosteroids, local anesthetics, or contrast media
- History of prior SIJ surgery or joint fusion
- Previous sacroiliac joint injection within the last 3 months
- Pregnancy or breastfeeding
- Severe spinal or pelvic deformity preventing safe and accurate needle placement
- Significant cognitive impairment precluding informed consent or reliable outcome reporting
- Active malignancy involving the pelvis or sacrum
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Intra-Articular Sacroiliac Joint Injection
Participants receive a fluoroscopy-guided intra-articular injection into the lower third of the sacroiliac joint. A 22-gauge spinal needle is advanced under C-arm fluoroscopy (15-25° ipsilateral oblique view). Needle placement is confirmed with 0.5-1 mL iohexol contrast medium demonstrating an intra-articular arthrogram. Patients receive 3 mL total injectate containing 40 mg (1 mL) methylprednisolone acetate and 2 mL bupivacaine 0.25%. |
Under continuous C-arm fluoroscopic guidance (15-25° ipsilateral oblique view), a 22-gauge spinal needle is advanced into the synovial cavity of the lower third of the sacroiliac joint using a posteroanterior approach. Proper intra-articular needle position is verified by injecting 0.5-1 mL iohexol contrast medium to confirm an arthrogram pattern. A 3 mL injectate consisting of methylprednisolone acetate 40 mg (1 mL) and bupivacaine 0.25% (2 mL) is then administered. |
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Eksperymentalny: Periarticular Sacroiliac Joint Injection
Participants receive a fluoroscopy-guided periarticular injection targeting the posterior sacroiliac ligament complex and posterior capsular tissues overlying the middle and upper thirds of the joint. Needle position is confirmed with contrast showing spread along the posterior capsule without intra-articular filling. Patients receive up to 5 mL total injectate containing 40 mg (1 mL) methylprednisolone acetate and bupivacaine 0.25% in a fan-like distribution. |
Under fluoroscopic guidance, a 22-gauge spinal needle is directed toward the posterior capsular region and posterior sacroiliac ligament complex overlying the middle and upper thirds of the joint. Correct placement is confirmed via contrast injection showing spread along the posterior capsular surface without intra-articular entry. An injectate of up to 5 mL containing methylprednisolone acetate 40 mg (1 mL) and bupivacaine 0.25% is deposited in a fan-like distribution. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 4 Weeks
Ramy czasowe: Baseline and 4 weeks post-injection
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Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS), where scores range from 0 to 10 (0 = "no pain", 10 = "worst imaginable pain"). This measure evaluates the change in pain score from baseline to 4 weeks post-procedure. A greater reduction or lower score indicates greater pain relief. |
Baseline and 4 weeks post-injection
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IA vs PA Sacroiliac Injection
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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