Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02369068
Other study ID # 2015-008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date September 24, 2018

Study information

Verified date July 2019
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 24, 2018
Est. primary completion date March 26, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Onabotulinumtoxin A
Intravaginal pelvic floor injection one series
Kenalog
Intravaginal pelvic floor injection one series

Locations

Country Name City State
United States Beaumont Hospitals Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
Jamie Bartley, DO

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS). 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. Baseline and One Month
Primary 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. 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. Baseline and One Month
Primary Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. 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. Baseline and One Month
Primary Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. 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). Baseline and One Month
Secondary Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. 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. Baseline and Three Months
Secondary 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. 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. Baseline and Three Months
Secondary Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. 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. Baseline and Three months
Secondary Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. 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). Baseline and Three Months
Secondary Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. 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. Baseline and Six Months
Secondary 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. 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. Baseline and Six Months
Secondary Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. 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. Baseline and Six months
Secondary Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire. 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). Baseline and Six Months
See also
  Status Clinical Trial Phase
Completed NCT04077801 - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed NCT03740932 - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Recruiting NCT03868137 - Multi-dose Ibuprofen Prophylaxis for IUD-insertion N/A
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Completed NCT02547857 - Transvaginal Pelvic Ultrasound in the ED N/A
Completed NCT02923245 - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound N/A
Completed NCT01938092 - Vaginal Diazepam for the Treatment of Female Pelvic Pain Phase 2
Active, not recruiting NCT01731470 - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) N/A
Completed NCT01421641 - Tenaculum Pain Control Study Phase 4
Completed NCT00034047 - Endometriosis : Traditional Medicine vs Hormone Therapy Phase 1/Phase 2
Completed NCT05368155 - Chronic Pelvic Pain and Education Skills Training for Women Veterans N/A
Completed NCT04179149 - Enriched Environments in Endometriosis N/A
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Completed NCT04077775 - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed NCT03715777 - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain Phase 3
Recruiting NCT05926752 - Photobiomodulation for Myofascial Pelvic Pain N/A
Completed NCT02588885 - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention N/A
Completed NCT02261740 - Program to Overcome Pelvic Pain With Yoga N/A