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Completed

NCT Number: NCT03564106

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

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.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut governorate

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraarticular radiofrequency + intraarticular methylprednisolone

Drug

intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)

intraarticular methylprednisolone

Drug

intraarticular methylprednisolone (30 mg)

Primary outcomes

  1. pain intensity

    Time frame: up to 6 months

    Numeric Rating Scale (NRS)

Secondary outcomes

  1. Patient Impression

    Time frame: up to 6 months

    Patient Global Impression of Change Scale (PGIC)

  2. Pain Disability

    Time frame: up to 6 months

    Pain Disability Index ( PDI)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 20, 2018
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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