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Completed

NCT Number: NCT05520463

Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.

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Key information

Conditions

Sacroiliac Joint Arthritis Arthritis Back Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sacroiliitis Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.
  • 50% pain relief after prognostic sacral lateral branch block
  • At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test]
  • Refractory to conservative therapy

Exclusion criteria

The exclusion criteria were;

  • Uncontrolled psychiatric or neurological illness
  • Sacroiliac joint pain due to other disorders,
  • Lumbar radiculopathy
  • Rheumatological diseases
  • Systemic active infections
  • Malignancies, previous surgery on the affected sacroiliac joint,
  • History of traumatic hip injury,
  • History of bleeding disorders,
  • Platelet values < 150.000 / µl,
  • Sacroiliac joint injection within the preceding 3 months,
  • Allergy to local anesthetics and steroids,
  • Pregnancy, inability to concent, Implanted pacemaker or defibrilator.

Treatment and study plan

Sacral lateral branch radiofrequency ablation under ultrasound guidance

Procedure

Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.

Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

Procedure

Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

Primary outcomes

  1. Change in pain numerical rating score from baseline

    Time frame: 3 months

    The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable'

Secondary outcomes

  1. Performance time

    Time frame: During the procedure

    Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed

  2. Patient satisfaction

    Time frame: At 3 months

    Changes in overall satisfaction will be assessed using a 5-point Likert scale. (1, very dissatisfied; 2, dissatisfied; 3, neutral; 4, satisfied; 5, very satisfied).

  3. Pain medication use

    Time frame: At 3 months

    Mean change in analgesic consumption is assessed using QAQ, a tool designed to record patient-reported pain medication use. The higher score indicates higher pain medication use

  4. Success rate

    Time frame: At 3 months

    Proportions of reporting >50% pain relief.

  5. Functional disability

    Time frame: At 1 and 3 months

    Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible

  6. Quality of life ( SF-36)

    Time frame: At 1 and 3 months

    Quality of life (QoL) will assessed via SF-36, which consists of 36 items ad 2 summary values for Physical Component Summary ( PSC) and Mental Component Summary (MSC). Subscale scores range from 0 to 100, with 100 being the most positive QoL in that area and 0 the lowest;

  7. The number of needle passess

    Time frame: During the procedure

    The number of attempts during the performance will be analysed.

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2022
Registry last updated
Jul 7, 2023

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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