Effectiveness Of Alcohol Addition In Ultrasound-Guided Periarticular Sacroiliac Joint Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sacro Iliac Joint Pain Low Back Pain Alcohol Induced Neurolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group (group A)

receives a mixture of alcohol 30%, dexamethasone and lidocaine 2%

Group Type EXPERIMENTAL

sacroiliac joint injection

Intervention Type PROCEDURE

US-guided periarticular sacroiliac joint injection of a mixture of alcohol 30%, dexamethasone and lidocaine 2%

Active comparator group (group D)

receives a mixture of dexamethasone and lidocaine 2%

Group Type ACTIVE_COMPARATOR

sacroiliac joint injection

Intervention Type PROCEDURE

US-guided periarticular sacroiliac joint injection of a mixture of dexamethasone and lidocaine 2%

Interventions

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sacroiliac joint injection

US-guided periarticular sacroiliac joint injection of a mixture of dexamethasone and lidocaine 2%

Intervention Type PROCEDURE

sacroiliac joint injection

US-guided periarticular sacroiliac joint injection of a mixture of alcohol 30%, dexamethasone and lidocaine 2%

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients of either gender diagnosed with sacroiliac joint pain.
2. Patient aged 18-60 years old.
3. Patients with American Society of Anesthesiologists (ASA) physical status I-II.
4. Chronic pain at sacroiliac joint for more than 12 weeks.

Exclusion Criteria

1. Patients with MRI confirmed other cause of Low back pain as (disc prolapse, spinal canal stenosis, etc.).
2. Patients without any positive provocative tests (FABER, Gaenslen's and Fortin's finger tests).
3. Patients had findings suggestive of another source of axial back pain.
4. Patients with symptoms radiating past the knee.
5. Patients with less than 5/5 strength in the lower extremity.
6. Patients with diminished reflexes.
7. Patients diagnosed with myelopathy, and positive neural tension signs including straight leg raise and/or slump test.
8. Obese patients (BMI ≥ 35 kg/m²).
9. Infection at the injection site.
10. Patients who have undergone previous spine or pelvic surgery.
11. Coagulation disorders as bleeding tendency and platelet dysfunction.
12. Allergy to local anesthetics.
13. Patients with mental disorders, as well as drug abuse.
14. Lumbar facet steroid injections within the past 12 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No