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Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection

ConditionsSacro Iliac Joint PainLow Back PainSacroiliatis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorFayoum University Hospital

About this trial

The aim of this study is to assess whether the addition of sacral submultifidus block to standard image-guided SIJ injection provides superior analgesia and functional improvement compared with SIJ injection alone in patients with chronic SIJ-mediated pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1. refusal to participate. 2. Allergy or contraindication to local anesthetics. 3. Coagulation disorders or ongoing anticoagulant therapy. 4. Infection at the block injection site. 5. Chronic opioid use or substance abuse. 6. Neurological or psychiatric disorders affecting pain assessment. 7. Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SIJ Injection Alone

    Drug

    will receive SIJ Injection Alone ) , will receive SIJ Injection Alone :The sacroiliac joint will be identified under real-time ultrasound guidance. low- frequency curvilinear transducer is used, The transducer is placed transversely over the lower part of the sacrum (at the level of the sacral hiatus), and the lateral edge of the sacrum is identified. Then the transducer is moved laterally and cephalad till the bony contour of the ileum is clearly identified. The cleft seen between the medial border of the ileum and the lateral sacral edge represents the SI joint, and the inferior-most point is targeted. needle is then inserted at the medial end of the transducer and advanced laterally under direct vision in plane with the ultrasound beam, Following skin infiltration with a small volume of local anesthetic (e.g., lidocaine 1%), a 22-25G spinal needle 50mm block needle (SONOTAP, Pajunk , Geisingen ,Germany ),will be advanced toward the inferior third of the sacroiliac j

  • receive SIJ Injection & Sacral Submultifidus Block

    Drug

    receive SIJ Injection \& Sacral Submultifidus Block). group B (intervention group: will receive SIJ Injection \& Sacral Submultifidus Block).:2.Sacral Submultifidus Block (group A and group B): After completion of the SIJ injection, patients in the intervention group will receive an ultrasound-guided sacral submultifidus block (device used is GE healthcare model LOGIQ P7). A low-frequency curvilinear transducer will be placed longitudinally over the sacrum to identify key anatomical landmarks, including the median sacral crest, intermediate sacral crest, and overlying multifidus muscle. A 22G block needle will be inserted using an in-plane technique in a cranial-to-caudal or lateral-to-medial direction, targeting the fascial plane between the multifidus muscle and the underlying sacral lamina. After careful aspiration to exclude intravascular placement, 8 mL of local anesthetic (e.g., bupivacaine .25%) combined with 8 mg dexamethasone ( 2 ml) and the total volume will b

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: group A (control group: will receive SIJ Injection Alone ) ,Active comparator 1 intervention
Group B: group B (intervention group: will receive SIJ Injection & Sacral Submultifidus Block).Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain intensity measured by Visual Analog Scale (VAS)

0: no pain 1-3 : mild pain 4-6 : moderate to severe pain 7-9 : very severe 10 :worst pain

Time frame
at 1 week and 1 month , 2 months , 4 months , 6 months .

Secondary outcomes

1

Oswestry Disability Index (ODI)

0% to 20% (Minimal Disability) 21% to 40% (Moderate Disability) 41% to 60% (Severe Disability) 61% to 80% (Crippled) 81% to 100%: You are mostly bed-bound

Time frame
at baseline, 1 month, 3 months and 6 months
2

Patient Satisfaction Score (PSS):

High Scores (e.g., 4 to 5 on a 5-point scale, or 80%+): Suggest that patients feel respected, communication is clear Moderate Scores (Neutral/3): Indicate friction or missed expectations Low Scores (1 to 2): Point to severe breakdowns in communication, unaddressed comfort or pain management needs

Time frame
immediate, at 1 month, 3 months and 6 months .
3

Time to first postoperative analgesic dose

Time frame
from completion of the sacroiliac joint injection to the patient's first request for analgesia
4

Cumulative analgesic consumption

amounts of Gabapentin XR 300 mg at 1 week, 1 month , 2 months, 4 months and 6 months after injection.

Time frame
at 1 week, 1 month , 2 months, 4 months and 6 months after injection.

Other outcomes

Sponsors and contacts

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Fayoum University Hospital

Lead sponsor

Source ClinicalTrials.gov
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