Randomized Control Trial of Magnesium-Based Trigger Point Injections vs. Lidocaine-Only Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain

OBGY-276-15

This study will be a randomized, controlled, double-blinded, single-centre superiority trial with two parallel groups. The primary outcome will be average myofascial pelvic pain in the two weeks following final injection treatment as assessed using the visual analogue scale. Randomization will be performed as block randomization with a 1:1 allocation ratio, stratified based on opioid use at the time of study enrollment. In total, 60 participants will be recruited and randomized, with 30 being assigned to each treatment arm. The study will be restricted such that none of the participants enrolled will be current concomitant opioid users (for any reason) and will not have used opioid drugs within the 3 months preceding enrollment in the study. A third non-randomized arm of 30 participants who are on the waiting list for the chronic pain clinic will be enrolled and compared to the two randomized arms. Among this patient population and in the setting of the Chronic Pain Clinic it was determined that it would not be acceptable to randomize participants to a no-treatment control group. As such, an active treatment is being used as comparator in the randomized trial. In order to assess participants in the absence of treatment this third non-randomized arm will serve as a no-treatment control group. Eligibility criteria for this third arm is the same as the main study, except for the restriction by opioid use status. Participation in this third arm will not exclude a participant from randomization into one of the two main arms of the study. Therefore, across the three arms, up to 90 patients will be enrolled in this study.

2016-04-01

2020-03-01

2020-04-01

Terminated

Early phase I

38

Potential participants will be screened for eligibility based on the following inclusion and exclusion criteria. All of the following criteria will be used to screen participants for enrollment and randomization into one of the two treatment arms. All of the following criteria except for inclusion criteria number 2 and exclusion criteria number 10 will be used to screen participants for enrollment into the third wait-listed patient arm. These eligibility exceptions are necessary for the third arm as opioid medication may be introduced as temporary medical management for the condition while patients wait for acceptance into the Chronic Pain Clinic. Inclusion Criteria: 1. Patients with a clinical diagnosis of chronic pelvic pain lasting 6 months or greater 2. Not an opioid user: no opioid analgesic use for relief of chronic pelvic pain within the last 3 months Exclusion Criteria: 1. Age \<18 years or age \>65 years at the time of study enrollment 2. Pregnancy (currently pregnant or planning to become pregnant during the study period) 3. Known allergy or sensitivity to local anesthetics, dextrose, sodium bicarbonate or magnesium-sulfate 4. A clinical diagnosis of fibromyalgia 5. Having received previous trigger point injections of any formulation for pelvic pain 6. Bleeding disorders (including, but not limited to, hemophilia and von Willebrand disease) 7. Currently receiving anticoagulation therapy (including, but not limited to, coumadins, heparin and its derivatives, direct thrombin inhibitors, and anti-thrombin protein therapeutics; use of low dose aspirin is permitted) 8. Living greater than 50 km to the pain clinic at Hotel Dieu Hospital in Kingston, Ontario, Canada 9. Current opioid analgesic use for a reason other than chronic pelvic pain (including, but not limited to, ongoing opioid dependency or relief of other pain symptoms) 10. Recent opioid analgesic use for relief of chronic pelvic pain; defined as use within the last 3 months but not within the last 2 weeks prior to enrollment

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2023-03-31