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

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Bupivacaine; Drug: Saline

• Registration Number: NCT01520415
• Lead Sponsor: Dr. Yoram Shir

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 available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-30
• Primary Completion: 2013-06
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-26
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine	Bupivacaine	-
saline	Saline	-

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold of the myofascial trigger points	12 weeks	Change in the pressure pain threshold will be measured using a pressure algometer.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alan Edwards Pain Management Unit - Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada