Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369068
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : February 6, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jamie Bartley, DO, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE February 5, 2015
First Posted Date  ICMJE February 23, 2015
Results First Submitted Date  ICMJE December 10, 2018
Results First Posted Date  ICMJE February 6, 2019
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS). [ Time Frame: Baseline and One Month ]
    The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased.
  • Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire. [ Time Frame: Baseline and One Month ]
    Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 1 month and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.
  • Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. [ Time Frame: Baseline and One Month ]
    The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores from questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 1 month and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.
  • Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. [ Time Frame: Baseline and One Month ]
    The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2015)
  • Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire. [ Time Frame: One Month ]
    The VAS is a questionnaire that asks subjects to rate their level of pain on a scale from 1-10 with 1 being 'No pain' and 10 being 'Worst pain imaginable'.
  • Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. [ Time Frame: One Month ]
    The BPI is a questionnaire that includes information about the location, the severity (0 - No pain - 10 - Pain as bad as you can imagine), the use of pain relief treatments and if pain interfered with activities of daily living and sleep.
  • Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire. [ Time Frame: One Month ]
    The GRA is a questionnaire asking subjects to rate pain, bladder, bowel and sexual functions after having the research procedure from 'markedly improved' to 'markedly worse'.
Change History Complete list of historical versions of study NCT02369068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. [ Time Frame: Baseline and Three Months ]
    The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 3 months and the visual analog scale at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.
  • Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire. [ Time Frame: Baseline and Three Months ]
    Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 3 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.
  • Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. [ Time Frame: Baseline and Three months ]
    The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores together for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 3 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.
  • Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. [ Time Frame: Baseline and Three Months ]
    The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).
  • Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. [ Time Frame: Baseline and Six Months ]
    The pain visual analog scale (VAS) is a tool used by the patient to describe their pain intensity. Utilizing the VAS, the patient describes their pain at baseline, before receiving trigger point injections. The VAS ranges from 0 (no pain) to 10 (worst possible pain). Thus, a lower value represents a better outcome.
  • Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire. [ Time Frame: Baseline and Six Months ]
    Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 6 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased.
  • Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. [ Time Frame: Baseline and Six months ]
    The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding together scores for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 6 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased.
  • Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire. [ Time Frame: Baseline and Six Months ]
    The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2015)
  • Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. [ Time Frame: Three Months ]
    The VAS is a questionnaire that asks subjects to rate their level of pain on a scale from 1-10 with 1 being 'No pain' and 10 being 'Worst pain imaginable'.
  • Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. [ Time Frame: Three Months ]
    The BPI is a questionnaire that includes information about the location, the severity (0 - No pain - 10 - Pain as bad as you can imagine), the use of pain relief treatments and if pain interfered with activities of daily living and sleep.
  • Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire. [ Time Frame: Three Months ]
    The GRA is a questionnaire asking subjects to rate pain, bladder, bowel and sexual functions after having the research procedure from 'markedly improved' to 'markedly worse'.
  • Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. [ Time Frame: Six Months ]
    The VAS is a questionnaire that asks subjects to rate their level of pain on a scale from 1-10 with 1 being 'No pain' and 10 being 'Worst pain imaginable'.
  • Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. [ Time Frame: Six Months ]
    The BPI is a questionnaire that includes information about the location, the severity (0 - No pain - 10 - Pain as bad as you can imagine), the use of pain relief treatments and if pain interfered with activities of daily living and sleep.
  • Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire. [ Time Frame: Six Months ]
    The GRA is a questionnaire asking subjects to rate pain, bladder, bowel and sexual functions after having the research procedure from 'markedly improved' to 'markedly worse'.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain
Official Title  ICMJE A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain
Brief Summary The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).
Detailed Description Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Pain
Intervention  ICMJE
  • Drug: Onabotulinumtoxin A
    Intravaginal pelvic floor injection one series
    Other Name: Botox
  • Drug: Kenalog
    Intravaginal pelvic floor injection one series
    Other Name: triamcinolone
Study Arms  ICMJE
  • Experimental: Onabotulinumtoxin A

    Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.

    An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).

    Intervention: Drug: Onabotulinumtoxin A
  • Active Comparator: Kenalog

    Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.

    A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).

    Intervention: Drug: Kenalog
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2015)
40
Actual Study Completion Date  ICMJE September 24, 2018
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provide informed consent
  • Healthy women > age 18 regardless of menopausal status
  • Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
  • High-tone pelvic floor dysfunction on vaginal exam
  • A pelvic pain score of > 4 on screening Visual Analog Scale (VAS)
  • Pain perceived to be in the pelvis that has been present for at least 3 months.

Exclusion Criteria:

  • Patients that have had Botox to the bladder within the last 8 months
  • Patients that have had Botox outside the bladder of > 160 u within the last 12 weeks.
  • Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
  • Pregnancy
  • Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
  • Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
  • Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
  • Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
  • Systolic blood pressure > 160 mm Hg on screening blood pressure
  • Heart rate > 110 beats/minute on screening heart rate
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02369068
Other Study ID Numbers  ICMJE 2015-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jamie Bartley, DO, William Beaumont Hospitals
Study Sponsor  ICMJE Jamie Bartley, DO
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamie Bartley, DO Beaumont
PRS Account William Beaumont Hospitals
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP