Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients

NCT ID: NCT01520415

Last Updated: 2013-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to examine the short and long-term effect of myofascial trigger point injections with either a local anesthetic or saline in patients with chronic low back pain presenting with myofasical pain syndrome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Intervention Type DRUG

Saline

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lidocaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* CLBP of non-malignant origin, with or without accompanying leg pain, including patients with history of previous back surgery or trauma
* MPS as evident by at least one active MTP, located medial or lateral to the posterior iliac crest involving the gluteus maximus or medius, quadratus lumborum and erector spinae muscles
* While not precluding the participation in the study, MTP in other areas will not make patients eligible
* Pain lasting for at least six months

Exclusion Criteria

* Any current motor weakness, but not sensory loss or abnormal reflexes in the lower limbs
* Any injection or nerve block in the low back in the last 6 months
* Local or systemic infection
* Bleeding disorder or the use of anticoagulation medications
* Known allergy to local anesthetics
* Poor understanding of written and spoken English or French
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Yoram Shir

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Yoram Shir

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yoram Shir, MD

Role: PRINCIPAL_INVESTIGATOR

MUHC-RI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AEPMU-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.