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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520415
• Other study ID #: AEPMU-01
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2012
• Last updated: July 26, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Canada	Alan Edwards Pain Management Unit - Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Yoram Shir

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain threshold of the myofascial trigger points	Change in the pressure pain threshold will be measured using a pressure algometer.	12 weeks	No
Secondary	Pressure pain threshold of MTPs	Change in the pressure pain threshold of MTPs after each MTP injection.	baseline, 4 weeks, 8 weeks	No
Secondary	VAS Low Back Pain	Change in pain intensity after each MTPI and at the end of the study.	baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Roland-Morris Disability Questionnaire (RDQ-20)	Change in disability levels after each MTPI and at the end of the study.	baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Short-Form Health Status Survey 12 (SF-12)	Change in functional status, well-being and quality of life after each MTPI and at the end of the study.	baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Consumption of analgesic medications	Change in the consumption of analgesic medications.	12 weeks	No
Secondary	Number of participants with Adverse Events	Adverse events resulting from the intervention.	12 weeks	Yes