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

July 26, 2013 updated by: Dr. Yoram Shir

A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: saline
Drug: Saline
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
ACTIVE_COMPARATOR: bupivacaine
Drug: Bupivacaine
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
Other Names:
  • lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold of the myofascial trigger points
Time Frame: 12 weeks
Change in the pressure pain threshold will be measured using a pressure algometer.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold of MTPs
Time Frame: baseline, 4 weeks, 8 weeks
Change in the pressure pain threshold of MTPs after each MTP injection.
baseline, 4 weeks, 8 weeks
VAS Low Back Pain
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
Change in pain intensity after each MTPI and at the end of the study.
baseline, 4 weeks, 8 weeks, 12 weeks
Roland-Morris Disability Questionnaire (RDQ-20)
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
Change in disability levels after each MTPI and at the end of the study.
baseline, 4 weeks, 8 weeks, 12 weeks
Short-Form Health Status Survey 12 (SF-12)
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
Change in functional status, well-being and quality of life after each MTPI and at the end of the study.
baseline, 4 weeks, 8 weeks, 12 weeks
Consumption of analgesic medications
Time Frame: 12 weeks
Change in the consumption of analgesic medications.
12 weeks
Number of participants with Adverse Events
Time Frame: 12 weeks
Adverse events resulting from the intervention.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Yoram Shir

Investigators

  • Principal Investigator: Yoram Shir, MD, MUHC-RI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (ESTIMATE)

January 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 26, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEPMU-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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