Low Back Pain, MechanicalPhase 3NCT02521519

Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP

A Phase 3 study testing Medial branch block in one side and paravertebral deep intramuscular (PDI) injection in people with Low Back Pain, Mechanical, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep intramuscular (PDI) injection for pain relief in chronic low back pain. Based on randomization in first intervention session, one side receives MBB and the other side takes PDI and in second session the pattern reverses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain, Mechanical
What is being tested?: Medial branch block in one side and paravertebral deep intramuscular (PDI) injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteCanada
Study dates: 25 Aug 2014to 27 Jan 2020
Phase: Phase 3
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

CLBP of non-malignant origin fulfilling the following criteria:
Pain lasting for at least three months
Pain in both the left and right sides of the back
Pain below the L2 vertebral body
Lumbar spine CT scan or MRI done in the last 2 years
Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days
Cognitive and physical ability to provide informed consent in English or French

Who cannot join

Neurologic signs or symptoms suggesting nerve root involvement
Strictly unilateral Low Back Pain (LBP)
CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease
Vascular malformations
Tumor
Infection

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Fractures
DISH (Diffuse idiopathic skeletal hyperostosis)
Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months
Prior spine surgery
Local or systemic infection
Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin
Known allergy to amid local anesthetics
Active insurance claim (CSST, SAAQ)
Uncontrolled psychiatric condition

Trial locations and contacts

1 site in 1 country.

Canada1 site

Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

Official title: Short Term Effects of Medial Branch Block vs Para-spinal Injection in Muscle Patients With Non-specific Chronic Low Back Pain

Read the detailed description

Pain relief following medial branch block (MBB) might be due to facet joints desensitization and/or myofascial trigger points' desensitization. Patients will be randomized to two groups. The first group receives MBB in one side and paravertebral deep intramuscular (PDI) injection in the other side of the back. Next week the pattern of injection will be reversed so the side which had received MBB will take PDI injection and PDI side will take MBB. Second group takes the intervention in reverse order.

Conditions: Low Back Pain, Mechanical
Being tested: Medial branch block in one side, paravertebral deep intramuscular (PDI) injection
Keywords: Facet induced pain, Myofascial pain, Trigger points, Low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medial branch block in one sideOther
MBB: Using sterile conditions, 25G needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.
paravertebral deep intramuscular (PDI) injectionOther
injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.

Study groups in NCT02521519
Study group	Role	What they receive
One side of the patient's back	Other	medial branch block (MBB): Using sterile conditions, 25 gauge needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site. Receives: Other: Medial branch block in one side
Other side of the patient's back	Other	These injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate. Receives: Other: paravertebral deep intramuscular (PDI) injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Chronic Low Back Pain (CLBP) measured by VAS
Measured: Seven days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 201427 Jan 2020

First posted13 Aug 2015 (estimated)
Study start25 Aug 2014
Primary completion22 Jan 2019
Study completion27 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02521519
Sponsor's protocol ID: 14-190
Status last verified: Oct 2026
First submitted: 7 Aug 2015
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain, Mechanical trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short Term Effects of Medial Branch Block vs Para-spinal Injection in Muscle Patients With Non-specific Chronic Low Back Pain
ClinicalTrials.gov ID: NCT02521519
Acronym / sponsor ID: 14-190
Conditions: Low Back Pain, Mechanical
Keywords: Facet induced pain, Myofascial pain, Trigger points, Low back pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 8 participants (actual)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
Study start: 25 Aug 2014
Primary completion: 22 Jan 2019 (actual)
Study completion: 27 Jan 2020 (actual)
First posted: 13 Aug 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
One side of the patient's back	Other	Other: Medial branch block in one sidemedial branch block (MBB): Using sterile conditions, 25 gauge needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.
Other side of the patient's back	Other	Other: paravertebral deep intramuscular (PDI) injectionThese injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

CLBP of non-malignant origin fulfilling the following criteria:
Lumbar spine CT scan or MRI done in the last 2 years
Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days
Cognitive and physical ability to provide informed consent in English or French

Key exclusion criteria (15 listed)

Neurologic signs or symptoms suggesting nerve root involvement
Strictly unilateral Low Back Pain (LBP)
CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease
Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months
Prior spine surgery

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
Medial branch block in one sideMBB: Using sterile conditions, 25G needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.	Other	One side of the patient's back
paravertebral deep intramuscular (PDI) injectioninjections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.	Other	Other side of the patient's back

Primary outcome

Change in Chronic Low Back Pain (CLBP) measured by VAS
Time frame: Seven days

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.

Related trials for Low Back Pain, Mechanical

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Recruiting
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Adia Med of Winter Park LLC Lower Back Pain Research Study
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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?

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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 26 Oct 2026. 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 Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Change in Chronic Low Back Pain (CLBP) measured by VAS (time frame: Seven days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02521519.

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 26 Oct 2026.