A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain

Johns Hopkins University30 enrolled

Overview

In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.

30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Low Back Pain

Interventions

radiofrequency denervationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sacroiliac joint pain * Age \> 18 Exclusion Criteria: * No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition

Locations (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

visual analogue scale pain score, Oswestry Disability Index

Time frame: 1, 3 and 6 months postprocedure

Secondary Outcomes

Medication reduction, global perceived effect, work status

Data from ClinicalTrials.gov

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