Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Randomized Control Trial of Magnesium-Based Trigger Point Injections vs. Lidocaine-Only Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain
Brief Summary:
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 half of the participants enrolled will be current concomitant opioid users (for any reason) and half will have not 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, with the exception of stratification and 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.