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

NCT ID: NCT00373724

Last Updated: 2008-05-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Back Pain

Keywords

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sacroiliac joint low back pain radiofrequency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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radiofrequency denervation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Sacroiliac joint pain
* Age \> 18

Exclusion Criteria

* No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Principal Investigators

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Steven P Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Srinivasa N Raja, MD

Role: STUDY_DIRECTOR

Johns Hopkins School of Medicine

Locations

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Walter Reed Army Medical Center

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

Site Status

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Cohen SP, Abdi S. Lateral branch blocks as a treatment for sacroiliac joint pain: A pilot study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):113-9. doi: 10.1053/rapm.2003.50029.

Reference Type BACKGROUND
PMID: 12677621 (View on PubMed)

Yin W, Willard F, Carreiro J, Dreyfuss P. Sensory stimulation-guided sacroiliac joint radiofrequency neurotomy: technique based on neuroanatomy of the dorsal sacral plexus. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2419-25. doi: 10.1097/01.BRS.0000085360.03758.C3.

Reference Type BACKGROUND
PMID: 14560094 (View on PubMed)

Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.

Reference Type BACKGROUND
PMID: 16244008 (View on PubMed)

Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.

Reference Type DERIVED
PMID: 18648237 (View on PubMed)

Other Identifiers

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05-03-23-05

Identifier Type: -

Identifier Source: org_study_id