NCT03564106

Brief Summary

The sacroiliac joint is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Sacroiliac joint pain is one of the most common causes of chronic low back pain, accounting for 10% to 27% of patients with chronic lower back pain. It is known to be caused by abnormal motion in this joint, namely, too much motion or too little motion. Patients with pain experience various degrees of pain in the low back, groin, buttock, or posterior thigh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2019

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

June 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

June 2, 2018

Last Update Submit

January 16, 2021

Conditions

Pain Management

Keywords

chronic sacroilitis,radiofrequancy,intraarticular steroids injection

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    Numeric Rating Scale (NRS)

    up to 6 months

Secondary Outcomes (2)

  • Patient Impression

    up to 6 months

  • Pain Disability

    up to 6 months

Study Arms (2)

group A

EXPERIMENTAL

receive intraarticular radiofrequency + methylprednisolone (30 mg)

Drug: intraarticular radiofrequency + intraarticular methylprednisolone

group C

EXPERIMENTAL

receive intraarticular methylprednisolone (30 mg)

Drug: intraarticular methylprednisolone

Interventions

intraarticular radiofrequency + intraarticular methylprednisoloneDRUG

intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)

group A
intraarticular methylprednisoloneDRUG

intraarticular methylprednisolone (30 mg)

group C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients must have chronic pain more than 6 months and have failed medical treatment.

You may not qualify if:

  • Infection at the site of injection
  • Opioids addiction
  • Coagulopathy or another bleeding diathesis
  • Those who refuse to participate in the study
  • Ankylosing Spondylitis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related Publications (4)

  • Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. doi: 10.1111/j.1526-4637.2006.00210.x. No abstract available.

    PMID: 17014598BACKGROUND

  • Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.

    PMID: 18996232BACKGROUND

  • Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

    PMID: 21055873BACKGROUND

  • Do KH, Ahn SH, Jones R, Jang SH, Son SM, Lee DG, Cho HK, Choi GS, Cho YW. A New Sacroiliac Joint Injection Technique and Its Short-Term Effect on Chronic Sacroiliac Region Pain. Pain Med. 2016 Oct;17(10):1809-1813. doi: 10.1093/pm/pnw003. Epub 2016 Feb 25.

    PMID: 27738191BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2018

First Posted

June 20, 2018

Study Start

March 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 15, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)