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

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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Saline


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br> | Drug: Bupivacaine<br>* 2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit<br>* Other names: lidocaine;|
| Placebo Comparator: saline<br> | Drug: Saline<br>* 2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold of the myofascial trigger points | Change in the pressure pain threshold will be measured using a pressure algometer. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold of MTPs | Change in the pressure pain threshold of MTPs after each MTP injection. | baseline, 4 weeks, 8 weeks | 
| 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 | 
| 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 | 
| 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 | 
| Consumption of analgesic medications | Change in the consumption of analgesic medications. | 12 weeks | 
| Number of participants with Adverse Events | Adverse events resulting from the intervention. | 12 weeks |