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Completed

NCT Number: NCT04326699

Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Bilateral sacroiliac joint injection in symptomatic lumbar disc prolapse under ultrasound guidance and studying the effect of this technique on pain, spine mobility and activity of daily living.

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Key information

Conditions

Lumbar Disc Herniation Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Low Back Pain Low Back Pain, Mechanical Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms Spinal Diseases Spine Stiffness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university

Sohag, 82749, Egypt

About this study

86 Patients with lumbar disc prolapse diagnosed by either MRI or CT will be included. All of them aged > 18 years with no special condition for the duration of disc prolapse. All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility. All participants had no or poor response to conservative treatment. Previous surgery, severe facet arthropathy, ankylosing spondylitis, sensory or motor deficit and wedge fracture were considered as exclusion criteria. Distraction, compression, thigh thrust, and sacral thrust were used to assess SIJ dysfunction only at baseline before injection. Fingertip to floor and Oswestry disability index (ODI) were used to assess mobility and function of the spine at baseline (before and after injection) and after 2 and 16 weeks. Visual Analogue Scale (VAS) was used for pain appraisal at the same intervals. Participants will be randomly assigned into active and control group using 1:1 allocation. In the active group bilateral SIJ injection will be performed under ultrasound US guidance. Under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Lumbar disc prolapse diagnosed by either MRI or CT were included.
  • All of them aged > 18 years
  • No special condition for the duration of disc prolapse.
  • All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility.
  • All participants had no or poor response to conservative treatment

Exclusion criteria

  • Previous surgery
  • Severe facet arthropathy
  • Ankylosing spondylitis
  • Sensory or motor deficit
  • Wedge fracture

Treatment and study plan

Bilateral SIJ injection

Procedure

under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ

Primary outcomes

  1. Pain assessment by visual analogue scale.

    Time frame: at baseline 0 time, after 2 weeks and after 16 weeks

    Visual analogue scale, 0 means no pain and 10 means the maximum possible pain.

  2. Spine mobility, finger tip to floor test

    Time frame: Baseline 0 time, after 2 weeks and after 16 weeks

    comparison to the intial values with each visit to detect changes with no definite references.

  3. Oswestry disability index

    Time frame: Baseline 0 time, after 2 weeks and after 16 weeks

    0 value means no disability and 100 means complete disability

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2020
Registry last updated
Nov 4, 2020

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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