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

NCT01520415 | Completed Phase 2

• 1 other identifier: AEPMU-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold of the myofascial trigger points

  Change in the pressure pain threshold will be measured using a pressure algometer.

  12 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

Drug: Bupivacaine

saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

Bupivacaine DRUG

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

Also known as: lidocaine

bupivacaine

Saline DRUG

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

saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Yoram Shir: lead

Study Sites (1)

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Bupivacaine; Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yoram Shir, MD

  MUHC-RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

CA (1)