Magnesium-Based Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain

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 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.

Conditions

• Pelvic Pain

Interventions

PROCEDURE

Magnesium-Based Injection Formulation

Each study kit will include 4 10cc syringes containing 7ml of 1% lidocaine, and 3 numbered glass vials. For those in the magnesium-based injection formulation arm the glass vials will be prepared as follows; 1) 10ml of 50% magnesium sulfate, 2) 20ml of 8.4% bicarbonate, and 3) 20ml of 50% dextrose. At the visit a study investigator will mix 2cc of vial 1, 5cc of vial 2 and 5cc of vial 3, for a total of 12cc of additive mixture. 3cc of this additive mixture will be then drawn in to each of the 4 pre-packaged lidocaine syringes, for a total of 10cc of final mixture per syringe. The concentration of components in the final mixture is 0.7% lidocaine, 0.8% sodium bicarbonate, 6.0% dextrose, and 2.5% magnesium sulfate.

PROCEDURE

Lidocaine-Only Injection Formulation

Each study kit will include 4 10cc syringes containing 7ml of 1% lidocaine, and 3 numbered glass vials. For those in the lidocaine-based injection formulation arm the glass vials will be prepared as follows; 1) 10ml of 0.9% sodium chloride, 2) 20ml of 0.9% sodium chloride, and 3) 20ml of 0.9% sodium chloride. At the visit a study investigator will mix 2cc of vial 1, 5cc of vial 2 and 5cc of vial 3, for a total of 12cc of additive mixture. 3cc of this additive mixture will be then drawn in to each of the 4 pre-packaged lidocaine syringes, for a total of 10cc of final mixture per syringe. The concentration of components in the final mixture is 0.7% lidocaine.

DRUG

lidocaine

DRUG

magnesium sulfate, bicarbonate, dextrose.

Sponsors & Collaborators

• Hotel Dieu Hospital

  collaborator OTHER

• Queen's University

  lead OTHER

Principal Investigators

• Romy Nitsch, MD, MHSc · Queen's University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2020-03-31

Completion

2020-04-30

Countries

• Canada

Study Locations