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

NCT02728037 | Terminated Phase 3

• 1 other identifier: OBGY-276-15
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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

Keywords

Myofascial Trigger Points; Myofascial Pain; Intramuscular Anesthetic Injection

Outcome Measures

Primary Outcomes (1)

• Mean Change in Average Pelvic Pain

  The primary outcome measure a comparison of the two treatment arms. It is the mean change in average pain in the week preceding the study visit, from baseline to final visit, as measured by the visual analogue pain scale. Using this scale participants rate their average pain over the last week on a scale from 0 to 10 by drawing an "x" on the horizontal line. This line is 10cm long and the participant's pain level is measured using a ruler to the millimeter mark and translated to a score out of 100mm. If the "x" falls between millimeter marks on the ruler the reader will round up to the nearest mark.

  12 Weeks

Secondary Outcomes (10)

• Mean Change in Functional Pelvic Pain

  12 Weeks

• Mean Change in Quality of Life

  12 Weeks

• Change in Average Daily Concomitant Opioid Analgesic Usage

  12 Weeks

• Procedural Pain

  12 weeks

• Time to Resolution of Symptoms

  12 Weeks

Study Arms (3)

Magnesium-Based Injection Formulation

EXPERIMENTAL

Examination will involve systematic palpation of the 3 distinct levels of pelvic musculature. Injections into level 1 and level 2 muscles will be done under ultrasound guidance. Level 3 injections will be facilitated with a trumpet guide when needed. As the pelvic muscle trigger points are identified they will be injected with 2-3ml of the prepared injection formulation. The investigator will continue until no further trigger points can be identified, a maximum dose of lidocaine has been used, or the participant indicates they wish to stop. The maximum dose of lidocaine is 5mg per kg of body weight (280 mg of lidocaine in a 55kg woman or approximately 40cc of the final mixture).

Procedure: Magnesium-Based Injection Formulation; Drug: lidocaine; Drug: magnesium sulfate, bicarbonate, dextrose.

Lidocaine-Only Injection Formulation

ACTIVE COMPARATOR

Examination will involve systematic palpation of the 3 distinct levels of pelvic musculature. Injections into level 1 and level 2 muscles will be done under ultrasound guidance. Level 3 injections will be facilitated with a trumpet guide when needed. As the pelvic muscle trigger points are identified they will be injected with 2-3ml of the prepared injection formulation. The investigator will continue until no further trigger points can be identified, a maximum dose of lidocaine has been used, or the participant indicates they wish to stop. The maximum dose of lidocaine is 5mg per kg of body weight (280 mg of lidocaine in a 55kg woman or approximately 40cc of the final mixture).

Procedure: Lidocaine-Only Injection Formulation; Drug: lidocaine

Wait-Listed Patients

NO INTERVENTION

This arm is a non-randomized, no-treatment arm consisting of women who are on the waiting list for the chronic pain clinic.

Interventions

Magnesium-Based Injection Formulation PROCEDURE

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.

Magnesium-Based Injection Formulation

Lidocaine-Only Injection Formulation PROCEDURE

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.

Lidocaine-Only Injection Formulation

lidocaine DRUG

Lidocaine-Only Injection Formulation; Magnesium-Based Injection Formulation

magnesium sulfate, bicarbonate, dextrose. DRUG

Magnesium-Based Injection Formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with a clinical diagnosis of chronic pelvic pain lasting 6 months or greater
• Not an opioid user: no opioid analgesic use for relief of chronic pelvic pain within the last 3 months
• Age \<18 years or age \>65 years at the time of study enrollment
• Pregnancy (currently pregnant or planning to become pregnant during the study period)
• Known allergy or sensitivity to local anesthetics, dextrose, sodium bicarbonate or magnesium-sulfate
• A clinical diagnosis of fibromyalgia
• Having received previous trigger point injections of any formulation for pelvic pain
• Bleeding disorders (including, but not limited to, hemophilia and von Willebrand disease)
• 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)
• Living greater than 50 km to the pain clinic at Hotel Dieu Hospital in Kingston, Ontario, Canada
• 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)
• 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

Sponsors & Collaborators

• Queen's University: lead
• Hotel Dieu Hospital: collaborator

Study Sites (1)

Department of Obstetrics & Gynecology, Queen's Unviersity

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (2)

• Jarrell JF, Vilos GA. Consensus Guidelines for the Management of Chronic Pelvic Pain: SOGC Clinical Practice Guidelines. No 164, Part 1 of 2, August 2005.

  BACKGROUND

• Leitch J, Webb A, Pudwell J, Chamberlain S, Henry R, Nitsch R. Magnesium-Based Trigger Point Infiltrations Versus Local Anaesthetic Infiltrations in Chronic Pelvic Myofascial Pain: A Randomized, Double-Blind, Controlled Study. J Obstet Gynaecol Can. 2022 Aug;44(8):877-885. doi: 10.1016/j.jogc.2022.02.129. Epub 2022 Mar 24.

  PMID: 35339694 DERIVED

MeSH Terms

Conditions

Pelvic Pain

Interventions

Lidocaine; Magnesium Sulfate; Bicarbonates; Glucose

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Anions; Ions; Electrolytes; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Romy Nitsch, MD, MHSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: April 5, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

CA (1)