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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01520415
First received: January 11, 2012
Last updated: July 26, 2013
Last verified: July 2013

January 11, 2012
July 26, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01520415 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Active Comparator: bupivacaine
    Intervention: Drug: Bupivacaine
  • Placebo Comparator: saline
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01520415
AEPMU-01
No
Dr. Yoram Shir, McGill University Health Center
Dr. Yoram Shir
Not Provided
Principal Investigator: Yoram Shir, MD MUHC-RI
McGill University Health Center
July 2013

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