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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01520415

Enrollment

Registered

2012-01-30

Start date

2012-01-31

Completion date

2013-07-31

Last updated

2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

DRUGBupivacaine

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

DRUGSaline

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
Pressure pain threshold of MTPs	baseline, 4 weeks, 8 weeks	Change in the pressure pain threshold of MTPs after each MTP injection.
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.
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026