Lumbar Disc HerniationNCT04326699
Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse
A study testing Bilateral SIJ injection in people with Lumbar Disc Herniation and Sciatica, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Sciatica, Low Back Pain, Mechanical
- What is being tested?
- Bilateral SIJ injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous surgery
- Severe facet arthropathy
- Ankylosing spondylitis
- Sensory or motor deficit
- Wedge fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study
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.
Read the detailed description
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.
- Being tested
- Bilateral SIJ injection
- Keywords
- Disc Prolapse, sacroiliac joint, Injection, Ultrasound
- Medical subject headings
- Intervertebral Disc Displacement, Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral SIJ injectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bilateral SIJ injection |
| control group | No intervention | The other group will not receive the sacroiliac joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment by visual analogue scale.
Visual analogue scale, 0 means no pain and 10 means the maximum possible pain.
Measured: 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.
Measured: Baseline 0 time, after 2 weeks and after 16 weeks
Oswestry disability index
0 value means no disability and 100 means complete disability
Measured: Baseline 0 time, after 2 weeks and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start15 Mar 2020
- Primary completion15 Sep 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326699
- Sponsor's protocol ID
- 15/3/2020
- Status last verified
- Nov 2020
- First submitted
- 25 Mar 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study
- ClinicalTrials.gov ID
- NCT04326699
- Acronym / sponsor ID
- 15/3/2020
- Keywords
- Disc Prolapse, sacroiliac joint, Injection, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacroiliac joint injection group | Active comparator | Procedure: Bilateral SIJ injectionThe 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. |
| control group | No intervention | –The other group will not receive the sacroiliac joint injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Previous surgery
- Severe facet arthropathy
- Ankylosing spondylitis
- Sensory or motor deficit
- Wedge fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral SIJ injectionunder 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 | Procedure or surgery | Sacroiliac joint injection group |
Primary outcome
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral SIJ injection in people with Lumbar Disc Herniation and Sciatica, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment by visual analogue scale. (time frame: at baseline 0 time, after 2 weeks and after 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.