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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine | Active Comparator |
| |
| saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Shir, MD | MUHC-RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alan Edwards Pain Management Unit - Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Saline | Drug | 2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D000083 | Acetanilides |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |