Back to resultsClinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
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
Sites / Locations
- Alan Edwards Pain Management Unit - Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
bupivacaine
saline
Arm Description
Outcomes
Primary Outcome Measures
Pressure pain threshold of the myofascial trigger points
Change in the pressure pain threshold will be measured using a pressure algometer.
Secondary Outcome Measures
Pressure pain threshold of MTPs
Change in the pressure pain threshold of MTPs after each MTP injection.
VAS Low Back Pain
Change in pain intensity after each MTPI and at the end of the study.
Roland-Morris Disability Questionnaire (RDQ-20)
Change in disability levels after each MTPI and at the end of the study.
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.
Consumption of analgesic medications
Change in the consumption of analgesic medications.
Number of participants with Adverse Events
Adverse events resulting from the intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01520415
Brief Title
Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
Official Title
A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Yoram Shir
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
lidocaine
Intervention Description
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
Primary Outcome Measure Information:
Title
Pressure pain threshold of the myofascial trigger points
Description
Change in the pressure pain threshold will be measured using a pressure algometer.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pressure pain threshold of MTPs
Description
Change in the pressure pain threshold of MTPs after each MTP injection.
Time Frame
baseline, 4 weeks, 8 weeks
Title
VAS Low Back Pain
Description
Change in pain intensity after each MTPI and at the end of the study.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Roland-Morris Disability Questionnaire (RDQ-20)
Description
Change in disability levels after each MTPI and at the end of the study.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Short-Form Health Status Survey 12 (SF-12)
Description
Change in functional status, well-being and quality of life after each MTPI and at the end of the study.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Consumption of analgesic medications
Description
Change in the consumption of analgesic medications.
Time Frame
12 weeks
Title
Number of participants with Adverse Events
Description
Adverse events resulting from the intervention.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Shir, MD
Organizational Affiliation
MUHC-RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alan Edwards Pain Management Unit - Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
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