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

This study is currently recruiting participants.

Verified January 2012 by McGill University Health Center

Sponsor:

Information provided by (Responsible Party):

McGill University Health Center

ClinicalTrials.gov Identifier:

NCT01520415

First received: January 11, 2012

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2012

Last Updated Date

January 24, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pressure pain threshold of the myofascial trigger points [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change in the pressure pain threshold will be measured using a pressure algometer.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01520415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pressure pain threshold of MTPs [ Time Frame: baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
Change in the pressure pain threshold of MTPs after each MTP injection.
VAS Low Back Pain [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Change in pain intensity after each MTPI and at the end of the study.
Roland-Morris Disability Questionnaire (RDQ-20) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Change in disability levels after each MTPI and at the end of the study.
Short-Form Health Status Survey 12 (SF-12) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Change in functional status, well-being and quality of life after each MTPI and at the end of the study.
Consumption of analgesic medications [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in the consumption of analgesic medications.
Number of participants with Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Adverse events resulting from the intervention.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

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

Other Name: lidocaine
Drug: Saline
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Study Arm (s)

Active Comparator: bupivacaine
Intervention: Drug: Bupivacaine
Placebo Comparator: saline
Intervention: Drug: Saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01520415

Other Study ID Numbers ^ICMJE

AEPMU-01

Has Data Monitoring Committee

Responsible Party

McGill University Health Center

Study Sponsor ^ICMJE

McGill University Health Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yoram Shir, MD

MUHC-RI

Information Provided By

McGill University Health Center

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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