NCT01520415CompletedPhase 2
A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome
Dr. Yoram Shir1 site in 1 country40 target enrollmentStarted: January 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pressure pain threshold of the myofascial trigger points
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
bupivacaine
Active Comparator
Intervention: Bupivacaine (Drug)
saline
Placebo Comparator
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pressure pain threshold of MTPs(baseline, 4 weeks, 8 weeks)
- VAS Low Back Pain(baseline, 4 weeks, 8 weeks, 12 weeks)
- Roland-Morris Disability Questionnaire (RDQ-20)(baseline, 4 weeks, 8 weeks, 12 weeks)
- Short-Form Health Status Survey 12 (SF-12)(baseline, 4 weeks, 8 weeks, 12 weeks)
- Consumption of analgesic medications(12 weeks)
- Number of participants with Adverse Events(12 weeks)
Investigators
Dr. Yoram Shir
Doctor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sites (1)
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