Low Back PainPhase 2NCT01520415
Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
A Phase 2 study testing Bupivacaine and Saline in people with Low Back Pain, run by Dr. Yoram Shir at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Bupivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome
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
- Being tested
- Bupivacaine, Saline
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called lidocaine
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
SalineDrug
2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | Not described Receives: Drug: Bupivacaine |
| saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold of the myofascial trigger points
Change in the pressure pain threshold will be measured using a pressure algometer.
Measured: 12 weeks
Secondary outcomes (6)
Pressure pain threshold of MTPs
Change in the pressure pain threshold of MTPs after each MTP injection.
Measured: baseline, 4 weeks, 8 weeks
VAS Low Back Pain
Change in pain intensity after each MTPI and at the end of the study.
Measured: 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.
Measured: 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.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Consumption of analgesic medications
Change in the consumption of analgesic medications.
Measured: 12 weeks
Number of participants with Adverse Events
Adverse events resulting from the intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Yoram Shir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Yoram Shir, MD, Principal investigator, MUHC-RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520415
- Sponsor's protocol ID
- AEPMU-01
- Status last verified
- Jul 2013
- First submitted
- 11 Jan 2012
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT01520415
- Acronym / sponsor ID
- AEPMU-01
- Conditions
- Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Yoram ShirUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: Bupivacaine |
| saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: lidocaine2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit | Drug | bupivacaine |
| Saline2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit | Drug | saline |
Primary outcome
Pressure pain threshold of the myofascial trigger points
Time frame: 12 weeks
Change in the pressure pain threshold will be measured using a pressure algometer.
6 secondary outcomes
Pressure pain threshold of MTPs
Time frame: baseline, 4 weeks, 8 weeks
VAS Low Back Pain
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Roland-Morris Disability Questionnaire (RDQ-20)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Short-Form Health Status Survey 12 (SF-12)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Consumption of analgesic medications
Time frame: 12 weeks
Number of participants with Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Shir, MD principal investigator
MUHC-RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine and Saline in people with Low Back Pain, run by Dr. Yoram Shir at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold of the myofascial trigger points (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.