NCT07151027

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

August 18, 2025

Last Update Submit

February 9, 2026

Conditions

Sacro Iliac Joint PainLow Back PainAlcohol Induced Neurolysis

Keywords

Sacroiliatissacroiliac joint injectionprolotherapyethanol in low back painpain management

Outcome Measures

Primary Outcomes (1)

  • 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.

    preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection

Secondary Outcomes (6)

  • Oswestry Disability Index (ODI)

    preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection

  • Patient Satisfaction Score (PSS)

    within 15 minutes after the procedure completion

  • Time to first postoperative analgesic dose

    interval (in hours) for the first 48 hours

  • Cumulative Gabapentin consumption

    1 week, 4 weeks, 8 weeks, 4 months and 6 months after injection.

  • Procedure discomfort

    within 15 minutes after the procedure completion

  • +1 more secondary outcomes

Study Arms (2)

Experimental group (group A)

EXPERIMENTAL

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

Procedure: sacroiliac joint injection

Active comparator group (group D)

ACTIVE COMPARATOR

receives a mixture of dexamethasone and lidocaine 2%

Procedure: sacroiliac joint injection

Interventions

sacroiliac joint injectionPROCEDURE

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

Active comparator group (group D)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FayoumU

Al Fayyum, Faiyum Governorate, Egypt

Location

MeSH Terms

Conditions

Low Back PainAgnosia

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 2, 2025

Study Start

August 25, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

EG(1)