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

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ClinicalTrials.gov Identifier: NCT02728037
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Kingston Health Sciences Centre
Hotel Dieu Hospital
Information provided by (Responsible Party):
Dr. Romy Nitsch, Queen's University

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.


Condition or disease Intervention/treatment Phase
Pelvic Pain Procedure: Magnesium-Based Injection Formulation Procedure: Lidocaine-Only Injection Formulation Drug: lidocaine Drug: magnesium sulfate, bicarbonate, dextrose. Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Magnesium-Based Trigger Point Injections vs. Lidocaine-Only Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain
Study Start Date : April 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Experimental: Magnesium-Based Injection Formulation
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

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.


Drug: lidocaine
Drug: magnesium sulfate, bicarbonate, dextrose.
Active Comparator: Lidocaine-Only Injection Formulation
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

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



Primary Outcome Measures :
  1. Mean Change in Average Pelvic Pain [ Time Frame: 12 Weeks ]
    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.


Secondary Outcome Measures :
  1. Mean Change in Functional Pelvic Pain [ Time Frame: 12 Weeks ]
    A comparison of the two treatment arms. Function will be scored at each visit using a validated functional pelvic pain scale. The functions of bladder, bowel, intercourse, walking, running, lifting, working and sleeping are each rated on a Likert scale from 0 to 4. With 0 corresponding to no pain and normal function and 4 corresponding to an inability to function because of pain. Participants are asked to rank these functions based on when their pain was at its worst in the last week. Both individual functions and overall function score will be considered.

  2. Mean Change in Quality of Life [ Time Frame: 12 Weeks ]
    A comparison of the two treatment arms. Quality of life will be scored using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) at the baseline, fifth, and final visit. The WHOQOL-BREF assesses quality of life in 4 domains of physical health, psychological health, social relationships, and environment through a series of 26 questions using a Likert scale from 1 to 5. Changes in each of these 4 domains over the course of treatment will be considered.

  3. Change in Average Daily Concomitant Opioid Analgesic Usage [ Time Frame: 12 Weeks ]
    At each study visit participants will be asked to report their average daily concomitant analgesic medication usage during the preceding week, which will be recorded in the concomitant medication log. Type of medication, dosage and frequency of usage will be recorded. This comparison will focus on opioid medication usage and the summary measure of number of days in the preceding week that at least one dose of an opioid medication was required will be used. If a participant required at least one dose of opioid medication every day of the preceding week then they will be assigned a summary measure of 7. If they only required at least one dose of opioid medication on two days in the preceding week then they will be assigned a summary measure of 2. Changes in these summary measures over the 12 week course of treatment will be compared between the two treatment arms.

  4. Procedural Pain [ Time Frame: 12 weeks ]
    A comparison of the two treatment arms. At each visit participants will be asked to report the level of pain experienced during administration of injections. Immediately following administration, participants will report this using the same visual analogue scale used to measure the primary outcome. Each participants average procedural pain score over the course of treatment will be calculated. These average procedural pain will be compared between treatment groups.

  5. Time to Resolution of Symptoms [ Time Frame: 12 Weeks ]
    A comparison of the two treatment arms. The time to resolution of symptoms to a manageable level in weeks of treatment will be compared between groups. Participants will stop receiving treatment either at their 8th visit (12 weeks from baseline) or earlier if they choose. Only those women who indicate that their pain has reached a manageable level at the time of treatment conclusion will be included in this analysis.

  6. Complications and/or Adverse Events [ Time Frame: 12 Weeks ]
    A comparison of the two treatment arms. At each study visit participants will be asked about any complications or adverse events that they may have experienced. Participants will also be monitored for complications and adverse events during the course of treatment at the pain clinic. The type and frequency of complications and adverse events will be compared between groups.

  7. Comparison with the Wait-List Arm for the Primary Outcome: Mean Change in Average Pelvic Pain [ Time Frame: 12 Weeks ]

    The primary outcome of 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 will be compared among the 3 study arms. The wait-listed arm will serve as a non-randomized, no-treatment comparison group.

    The primary outcome measure 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.


  8. Comparison with the Wait-List Arm for the Secondary Outcome: Mean Change in Functional Pelvic Pain [ Time Frame: 12 Weeks ]

    The wait-listed arm will serve as a non-randomized, no-treatment comparison group. A comparison of the 3 study arms will be completed.

    Function will be scored at each visit using a validated functional pelvic pain scale. The functions of bladder, bowel, intercourse, walking, running, lifting, working and sleeping are each rated on a Likert scale from 0 to 4. With 0 corresponding to no pain and normal function and 4 corresponding to an inability to function because of pain. Participants are asked to rank these functions based on when their pain was at its worst in the last week. Both individual functions and overall function score will be considered.


  9. Comparison with the Wait-List Arm for the Secondary Outcome: Mean Change in Quality of Life [ Time Frame: 12 Weeks ]

    The wait-listed arm will serve as a non-randomized, no-treatment comparison group. A comparison of the 3 study arms will be completed.

    A comparison of the two treatment arms. Quality of life will be scored using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) at the baseline, fifth, and final visit. The WHOQOL-BREF assesses quality of life in 4 domains of physical health, psychological health, social relationships, and environment through a series of 26 questions using a Likert scale from 1 to 5. Changes in each of these 4 domains over the course of treatment will be considered.


  10. Comparison with the Wait-List Arm for the Secondary Outcome: Change in Average Daily Concomitant Opioid Analgesic Usage [ Time Frame: 12 Weeks ]

    The wait-listed arm will serve as a non-randomized, no-treatment comparison group. A comparison of the 3 study arms will be completed.

    At each study visit participants will be asked to report their average daily concomitant analgesic medication usage during the preceding week, which will be recorded in the concomitant medication log. Type of medication, dosage and frequency of usage will be recorded. This comparison will focus on opioid medication usage and the summary measure of number of days in the preceding week that at least one dose of an opioid medication was required will be used. Changes in these summary measures over the 12 week course of treatment will be compared between the two treatment arms.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728037


Contacts
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Contact: Romy Nitsch, MD, MHSc 613-549-6666 ext 1327 nitschr@queensu.ca
Contact: Jessica Pudwell, MPH 613-549-6666 ext 3937 jessica.pudwell@queensu.ca

Locations
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Canada, Ontario
Department of Obstetrics & Gynecology, Queen's Unviersity Recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Romy Nitsch, MD, MHSc         
Sponsors and Collaborators
Queen's University
Kingston Health Sciences Centre
Hotel Dieu Hospital
Investigators
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Principal Investigator: Romy Nitsch, MD, MHSc Queen's University

Publications:
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.

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Responsible Party: Dr. Romy Nitsch, Assistant Professor, Obstetrics & Gynecology, Queen's University
ClinicalTrials.gov Identifier: NCT02728037     History of Changes
Other Study ID Numbers: OBGY-276-15
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Dr. Romy Nitsch, Queen's University:
Myofascial Trigger Points
Myofascial Pain
Intramuscular Anesthetic Injection

Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents