An interventional study of sacroiliac joint injection and sacroiliac joint injection in Sacro Iliac Joint Pain, Low Back Pain and Alcohol Induced Neurolysis, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Fayoum University · Not applicable, Interventional, and Treatment
The aim of this work is to evaluate the efficacy of adding alcohol to local anesthetics and steroids to provide pain relief in patients with sacroiliac joint pain.
Low back pain (LBP) is one of the most common health problems globally. According to the Global Burden of Disease (GBD) Study 2021, low back pain is the leading cause of years lived with disability worldwide. It affects approximately 619 million people globally, and this number is projected to increase to 843 million by 2050 due to population growth and aging. (1) LBP may arise from multiple anatomical structures, such as muscle, intervertebral disc, fascia, and facet joint. Another common cause of LBP includes the sacroiliac joint (SIJ). It is estimated that around 10-38% of LBP cases originated from the SIJ. (2) In addition to its prevalence, SIJ pain lacks valid clinical/diagnostic tests and no therapeutic modalities for long-term improvement have been found yet. (3) Treatment of SIJ pain is another dilemma, and a wide range of therapeutic modalities has been used, including pharmacotherapy, chiropractic manipulation, SIJ injection (local anesthetics, steroid, or mixture), and surgical fixation. (4) Steroid and local anesthetic (LA) injections are widely used for managing SIJ pain, and evidence supports their effectiveness, particularly in the short to intermediate term but long-term benefit usually requires repeat injections or alternative treatments as radiofrequency or prolotherapy (5,6,7) Recently, alcohol neurolysis has gained popularity and become a well-established interventional technique in pain management, particularly for patients with chronic or cancer-related pain that is refractory to conventional therapies. (8)
Alcohol (Ethanol) in different concentrations (from 70% to 20%) has been used in different joints and pain syndromes such as trigeminal neuralgia, post-mastectomy pain syndrome, ankle pain from Morton neuroma and bursitis, and it proved its efficacy and safety. (9,10,11,12) Previous studies tried phenol injection in SIJ pain which acts nearly with the same mechanism of action as ethanol exerting a neurolytic effect through protein denaturation and nerve fiber destruction. Also proved its efficacy and safety. (13, 14) No previous studies used alcohol injection in SIJ.This study hypothesize that the use of alcohol (ethanol) 30% as an adjuvant to steroids and local anesthetics in SIJ as a novel approach may offer both short and long-term pain relief and reduce the frequency of repeated injections.
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This study's enrollment of 54 is close to the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
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Exclusion Criteria:
receives a mixture of alcohol 30%, dexamethasone and lidocaine 2%
Procedure: sacroiliac joint injection
receives a mixture of dexamethasone and lidocaine 2%
Procedure: sacroiliac joint injection
US-guided periarticular sacroiliac joint injection of a mixture of dexamethasone and lidocaine 2%
US-guided periarticular sacroiliac joint injection of a mixture of alcohol 30%, dexamethasone and lidocaine 2%
Pain relief as measured by the visual analogue scale VAS scale
Presented by a 10 cm horizontal line representing the patient's pain intensity. Zero represents "no pain" while the upper limit (10 cm) represents the "worst pain imaginable.
Time frame: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection
Oswestry Disability Index (ODI)
is a questionnaire designed to assess the degree of disability in low back pain. It comprises 10 sections, pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and traveling. Each section is scored on a scale from 0 to 5, the total score is calculated by summing section scores, dividing by the maximum possible score, and multiplying by 100 to yield a percentage from 0 to 100% .with higher percentages denoting more severe disability. The total score is the number of questions with a positive response (yes) and reduction in four or more scores indicates that the treatment has achieved its goal.
Time frame: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection
Patient Satisfaction Score (PSS)
a self reported measure of a patient's overall satisfaction with care, a 5 point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied).
Time frame: within 15 minutes after the procedure completion
Time to first postoperative analgesic dose
interval (in hours) from completion of the sacroiliac joint injection to the patient's first request for analgesia recorded by nursing staff then patient and his relatives after discharge. A longer time to first dose indicates more prolonged analgesic effect of the injection.
Time frame: interval (in hours) for the first 48 hours
Cumulative Gabapentin consumption
Time frame: 1 week, 4 weeks, 8 weeks, 4 months and 6 months after injection.
Procedure discomfort
Procedure discomfort via VAS scale
Time frame: within 15 minutes after the procedure completion
Complications
I. Postoperative Nausea and Vomiting (PONV). II. Hyperalgesia III. Loss of Sensation IV. Lower Limb Muscle Weakness V. Infection at Injection Site
Time frame: six months after injection
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