NCT04326699

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

March 25, 2020

Last Update Submit

November 3, 2020

Conditions

Lumbar Disc HerniationSciaticaLow Back Pain, MechanicalSpine Stiffness

Keywords

Disc Prolapsesacroiliac jointInjectionUltrasound

Outcome Measures

Primary Outcomes (3)

  • Pain assessment by visual analogue scale.

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

    at baseline 0 time, after 2 weeks and after 16 weeks

  • Spine mobility, finger tip to floor test

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

    Baseline 0 time, after 2 weeks and after 16 weeks

  • Oswestry disability index

    0 value means no disability and 100 means complete disability

    Baseline 0 time, after 2 weeks and after 16 weeks

Study Arms (2)

Sacroiliac joint injection group

ACTIVE COMPARATOR

The active group will receive bilateral sacroiliac joint injection of 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) under ultrasound guidance.

Procedure: Bilateral SIJ injection

control group

NO INTERVENTION

The other group will not receive the sacroiliac joint injection

Interventions

Bilateral SIJ injectionPROCEDURE

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

Sacroiliac joint injection group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, 82749, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementSciaticaLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 30, 2020

Study Start

March 15, 2020

Primary Completion

September 15, 2020

Study Completion

October 15, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

EG(1)