Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis

NCT ID: NCT03564106

Last Updated: 2021-01-20

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

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-01-15

Brief Summary

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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.

Detailed Description

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The pain starts when the Sacroiliac joint gets inflamed. There are several reasons it could happen. It could be hurt when playing sports or if fall down.

Sometimes start hurting when the ligaments that hold the SI joint together are damaged, which may make the joint move abnormally. The pain associated with sacroiliitis most commonly occurs in the buttocks and lower back. It can also affect the legs, groin and even the feet.

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group A

receive intraarticular radiofrequency + methylprednisolone (30 mg)

Group Type EXPERIMENTAL

intraarticular radiofrequency + intraarticular methylprednisolone

Intervention Type DRUG

intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)

group C

receive intraarticular methylprednisolone (30 mg)

Group Type EXPERIMENTAL

intraarticular methylprednisolone

Intervention Type DRUG

intraarticular methylprednisolone (30 mg)

Interventions

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intraarticular radiofrequency + intraarticular methylprednisolone

intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)

Intervention Type DRUG

intraarticular methylprednisolone

intraarticular methylprednisolone (30 mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 17014598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18996232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21055873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27738191 (View on PubMed)

Other Identifiers

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17200203

Identifier Type: -

Identifier Source: org_study_id

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