Sacro Iliac Joint PainNCT07151027
Effectiveness Of Alcohol Addition In Ultrasound-Guided Periarticular Sacroiliac Joint Injection
A study testing sacroiliac joint injection in people with Sacro Iliac Joint Pain and Low Back Pain, run by Fayoum University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sacro Iliac Joint Pain, Low Back Pain, Alcohol Induced Neurolysis
- What is being tested?
- sacroiliac joint injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2025to 1 Feb 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients of either gender diagnosed with sacroiliac joint pain.
- Patient aged 18-60 years old.
- Patients with American Society of Anesthesiologists (ASA) physical status I-II.
- Chronic pain at sacroiliac joint for more than 12 weeks.
Who cannot join
- Patients with MRI confirmed other cause of Low back pain as (disc prolapse, spinal canal stenosis, etc.).
- Patients without any positive provocative tests (FABER, Gaenslen's and Fortin's finger tests).
- Patients had findings suggestive of another source of axial back pain.
- Patients with symptoms radiating past the knee.
- Patients with less than 5/5 strength in the lower extremity.
- Patients with diminished reflexes.
Show all 14Show fewer
- Patients diagnosed with myelopathy, and positive neural tension signs including straight leg raise and/or slump test.
- Obese patients (BMI ≥ 35 kg/m²).
- Infection at the injection site.
- Patients who have undergone previous spine or pelvic surgery.
- Coagulation disorders as bleeding tendency and platelet dysfunction.
- Allergy to local anesthetics.
- Patients with mental disorders, as well as drug abuse.
- Lumbar facet steroid injections within the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Of Alcohol Addition In Ultrasound-Guided Periarticular Sacroiliac Joint Injection: A Double Blinded Randomized Prospective Study
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.
Read the detailed description
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.
- Being tested
- sacroiliac joint injection
- Keywords
- Sacroiliatis, sacroiliac joint injection, prolotherapy, ethanol in low back pain, pain management
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacroiliac joint injectionProcedure or surgery
US-guided periarticular sacroiliac joint injection of a mixture of dexamethasone and lidocaine 2%
sacroiliac joint injectionProcedure or surgery
US-guided periarticular sacroiliac joint injection of a mixture of alcohol 30%, dexamethasone and lidocaine 2%
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (group A) | Experimental | receives a mixture of alcohol 30%, dexamethasone and lidocaine 2% Receives: Procedure: sacroiliac joint injection |
| Active comparator group (group D) | Active comparator | receives a mixture of dexamethasone and lidocaine 2% Receives: Procedure: sacroiliac joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: interval (in hours) for the first 48 hours
Cumulative Gabapentin consumption
Measured: 1 week, 4 weeks, 8 weeks, 4 months and 6 months after injection.
Procedure discomfort
Procedure discomfort via VAS scale
Measured: within 15 minutes after the procedure completion
Complications
- Postoperative Nausea and Vomiting (PONV). II. Hyperalgesia III. Loss of Sensation IV. Lower Limb Muscle Weakness V. Infection at Injection Site
Measured: six months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start25 Aug 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacro Iliac Joint PainStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Shawky Farhat Gergis, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151027
- Sponsor's protocol ID
- M797
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Alcohol Addition In Ultrasound-Guided Periarticular Sacroiliac Joint Injection: A Double Blinded Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07151027
- Acronym / sponsor ID
- M797
- Keywords
- Sacroiliatis, sacroiliac joint injection, prolotherapy, ethanol in low back pain, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 2 Sep 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (group A) | Experimental | Procedure: sacroiliac joint injectionreceives a mixture of alcohol 30%, dexamethasone and lidocaine 2% |
| Active comparator group (group D) | Active comparator | Procedure: sacroiliac joint injectionreceives a mixture of dexamethasone and lidocaine 2% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients of either gender diagnosed with sacroiliac joint pain.
- Patient aged 18-60 years old.
- Patients with American Society of Anesthesiologists (ASA) physical status I-II.
- Chronic pain at sacroiliac joint for more than 12 weeks.
Key exclusion criteria (14 listed)
- Patients with MRI confirmed other cause of Low back pain as (disc prolapse, spinal canal stenosis, etc.).
- Patients without any positive provocative tests (FABER, Gaenslen's and Fortin's finger tests).
- Patients had findings suggestive of another source of axial back pain.
- Patients with symptoms radiating past the knee.
- Patients with less than 5/5 strength in the lower extremity.
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 |
|---|---|---|
| sacroiliac joint injectionUS-guided periarticular sacroiliac joint injection of a mixture of dexamethasone and lidocaine 2% | Procedure or surgery | Active comparator group (group D) |
| sacroiliac joint injectionUS-guided periarticular sacroiliac joint injection of a mixture of alcohol 30%, dexamethasone and lidocaine 2% | Procedure or surgery | Experimental group (group A) |
Primary outcome
Pain relief as measured by the visual analogue scale VAS scale
Time frame: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection
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.
6 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection
Patient Satisfaction Score (PSS)
Time frame: within 15 minutes after the procedure completion
Time to first postoperative analgesic dose
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
Time frame: within 15 minutes after the procedure completion
Complications
Time frame: six months after injection
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 10 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacroiliac joint injection in people with Sacro Iliac Joint Pain and Low Back Pain, run by Fayoum University at 1 site in Egypt.
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 4 inclusion and 14 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 10 Feb 2026. 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 Egypt. 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?
Pain relief as measured by the visual analogue scale VAS scale (time frame: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection). 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 10 Feb 2026.