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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
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Drug: Bupivacaine
Drug: Saline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bupivacaine Drug: Bupivacaine
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
Other Name: lidocaine
Placebo Comparator: saline Drug: Saline
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520415

Locations
Canada, Quebec
Alan Edwards Pain Management Unit - Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Yoram Shir, MD         yoram.shir@muhc.mcgill.ca    
Contact: Linda Ferguson         linda.ferguson@muhc.mcgill.ca    
Principal Investigator: Yoram Shir, MD            
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Yoram Shir, MD MUHC-RI
  More Information

No publications provided

Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT01520415     History of Changes
Other Study ID Numbers: AEPMU-01
Study First Received: January 11, 2012
Last Updated: January 24, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Back Pain
Myofascial Pain Syndromes
Fibromyalgia
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Neuromuscular Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013