Back to resultsProvoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
Primary Purpose
Provoked, Localized Vulvodynia, Provoked Vestibulodynia, Vulvar Vestibulitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Classical Acupuncture
Non-classical acupuncture
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Provoked, Localized Vulvodynia focused on measuring Vulvodynia, Provoked, localized vulvodynia, vulvar vestibulitis, provoked vestibulodynia, vulvovaginal pain, vulvar pain, vaginal pain, chronic pain, lidocaine, numbing agent, anesthetic cream, acupuncture, electroacupuncture, electrical stimulated acupuncture, manual acupuncture, classical acupuncture, non-classical acupuncture, Traditional Chinese Medicine, TCM, Chinese medicine, Acupuncture and Oriental Medicine, AOM, treatment, feasibility, pilot study, Patient Reported Outcomes Measure Information System, Tampon Test, cotton swab test, pain diary, Research Electronic Data Capture, REDCap
Eligibility Criteria
Inclusion Criteria:
- Literate, English speaking, premenopausal, women meeting Friedrich's criteria for Provoked, localized vulvodynia
- Reported introital dyspareunia longer than three months duration;
- Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with cotton swab test and Tampon Test;
- Able to insert an Original Regular Tampax™ tampon.
Exclusion Criteria:
- Co-existing conditions leading to dyspareunia including generalized unprovoked vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or genital infection (e.g. herpes simplex virus or yeast infection).
- Pregnant or postpartum and breastfeeding;
- Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last six months. If taken for longer, must be on a stable dose for at least six months and still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs) are allowed;
- Postmenopausal as defined by surgical or natural menopause (no menses for 12 months);
- Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen for longer than three months duration;
- Must be able to refrain from other treatments for PLV including non-traditional options (e.g. other medications, physical therapy, sex therapy, acupuncture, naturopathic remedies) during the course of the study (6 months).
- Use of SNRIs, lidocaine, or acupuncture within the last three months.
Sites / Locations
- Women's Health Research Unit; Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Classical Acupuncture + Lidocaine
Non-classical acupuncture + lidocaine
Arm Description
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Outcomes
Primary Outcome Measures
Tampon Test
Primary outcome variable will be to measure the change in the reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 12);
Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
Secondary Outcome Measures
Cotton Swab test
Secondary outcome variable will compare the "Cotton Swab Test" with a blinded assessor reported pain at three timepoints. 1) change in reported pain at (mean at Weeks -2, -1, 0, and 1) to the reported pain (mean at Weeks 12 and 13; 2) change in reported pain (means Weeks -2, -1, 0, and 1) to the reported pain (mean at Week 24); 3) change in reported pain (mean at Week 12) to (mean at Week 24).
Vestibular tenderness will be assessed by light touch with a cotton swab by a blinded assessor to the study participant's: 1) vestibule (cotton swab test) at four defined points (1:00, 5:00, 7:00, and 11:00); 2) the perineum; 3) labia majora (2:00 and 8:00), and 4) labia minora (4:00 and 10:00). Tenderness at each location will be rated by the Study Participant on a 10-point scale (0 indicating no pain, 10 indicating worst possible pain).
Patient Reported Outcomes Measurement Information System (PROMIS) Scales
Assess changes in scores quality of life, vaginal discomfort, pain intensity, pain interference and behavior, anxiety, and depression at 6 weeks, 12 weeks, and 24 weeks compared to baseline.
Satisfaction
Using 5-point scales (Very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, Very dissatisfied), Study participants will be asked how satisfied they are with the study interventions and how satisfied they are with their pain relief.
Expectation
Study participants will be asked about how much they 'expect' the study interventions will or will not help, how much they 'think' the intervention will or will not help, and how much they 'feel' about the intervention will or will not help via 10-point scales.
Feasibility
Assess feasibility by the number of study participants enrolled.
Acceptability
Assess acceptability by the number of study visits attended by participants enrolled.
Tampon Test
Secondary outcome variables will be to:
measure the change in reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 6);
measure the change in reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 24);
measure the change in reported pain of the "Tampon Test" (mean at Week 12) to the reported pain of "Tampon Test" (mean of Week 24).
Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
Full Information
NCT ID
NCT01996384
First Posted
November 18, 2013
Last Updated
October 4, 2017
Sponsor
Oregon College of Oriental Medicine
Collaborators
National Vulvodynia Association, Council of Colleges of Acupuncture and Oriental Medicine, Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01996384
Brief Title
Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
Official Title
Acupuncture Augmentation of Lidocaine for the Treatment of Provoked, Localized vulvodynia-a Feasibility and Acceptability Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon College of Oriental Medicine
Collaborators
National Vulvodynia Association, Council of Colleges of Acupuncture and Oriental Medicine, Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.
Detailed Description
This is a randomized, controlled, single-blinded, pilot trial to study the feasibility and acceptability of acupuncture and 5% lidocaine. Patients will be recruited from the patient population of the Oregon Health & Science University Vulvar Health Clinic. Thirty (30) patients with PLV will be enrolled as study participants into the study. Fifteen (15) will be allocated in the treatment (classical) acupuncture + 5% lidocaine group and fifteen (15) will be allocated in the control (non-classical) acupuncture + 5% lidocaine group via a computer generated randomization program to balance allocation based on four variables: pain intensity, smoking status, body mass index, and pain duration.
The acupuncturist will interview each patient and perform an exam of the pulse and tongue. A standardized acupuncture treatment will be assigned, and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points, with or without mild electrical stimulation. All study participants will self-apply lidocaine cream to their genital region four times daily during the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked, Localized Vulvodynia, Provoked Vestibulodynia, Vulvar Vestibulitis, Vulvodynia
Keywords
Vulvodynia, Provoked, localized vulvodynia, vulvar vestibulitis, provoked vestibulodynia, vulvovaginal pain, vulvar pain, vaginal pain, chronic pain, lidocaine, numbing agent, anesthetic cream, acupuncture, electroacupuncture, electrical stimulated acupuncture, manual acupuncture, classical acupuncture, non-classical acupuncture, Traditional Chinese Medicine, TCM, Chinese medicine, Acupuncture and Oriental Medicine, AOM, treatment, feasibility, pilot study, Patient Reported Outcomes Measure Information System, Tampon Test, cotton swab test, pain diary, Research Electronic Data Capture, REDCap
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classical Acupuncture + Lidocaine
Arm Type
Experimental
Arm Description
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Arm Title
Non-classical acupuncture + lidocaine
Arm Type
Active Comparator
Arm Description
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Intervention Type
Procedure
Intervention Name(s)
Classical Acupuncture
Intervention Description
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Intervention Type
Procedure
Intervention Name(s)
Non-classical acupuncture
Intervention Description
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
5% Lidocaine cream
Intervention Description
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Primary Outcome Measure Information:
Title
Tampon Test
Description
Primary outcome variable will be to measure the change in the reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 12);
Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
Time Frame
Weeks 1 and 12 study period
Secondary Outcome Measure Information:
Title
Cotton Swab test
Description
Secondary outcome variable will compare the "Cotton Swab Test" with a blinded assessor reported pain at three timepoints. 1) change in reported pain at (mean at Weeks -2, -1, 0, and 1) to the reported pain (mean at Weeks 12 and 13; 2) change in reported pain (means Weeks -2, -1, 0, and 1) to the reported pain (mean at Week 24); 3) change in reported pain (mean at Week 12) to (mean at Week 24).
Vestibular tenderness will be assessed by light touch with a cotton swab by a blinded assessor to the study participant's: 1) vestibule (cotton swab test) at four defined points (1:00, 5:00, 7:00, and 11:00); 2) the perineum; 3) labia majora (2:00 and 8:00), and 4) labia minora (4:00 and 10:00). Tenderness at each location will be rated by the Study Participant on a 10-point scale (0 indicating no pain, 10 indicating worst possible pain).
Time Frame
Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Scales
Description
Assess changes in scores quality of life, vaginal discomfort, pain intensity, pain interference and behavior, anxiety, and depression at 6 weeks, 12 weeks, and 24 weeks compared to baseline.
Time Frame
At baseline visit, 6 weeks, 12 weeks, and 24 weeks
Title
Satisfaction
Description
Using 5-point scales (Very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, Very dissatisfied), Study participants will be asked how satisfied they are with the study interventions and how satisfied they are with their pain relief.
Time Frame
Weeks 12 and 24
Title
Expectation
Description
Study participants will be asked about how much they 'expect' the study interventions will or will not help, how much they 'think' the intervention will or will not help, and how much they 'feel' about the intervention will or will not help via 10-point scales.
Time Frame
Week 1
Title
Feasibility
Description
Assess feasibility by the number of study participants enrolled.
Time Frame
Weeks 12 and 24
Title
Acceptability
Description
Assess acceptability by the number of study visits attended by participants enrolled.
Time Frame
Weeks 12 and 24
Title
Tampon Test
Description
Secondary outcome variables will be to:
measure the change in reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 6);
measure the change in reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 24);
measure the change in reported pain of the "Tampon Test" (mean at Week 12) to the reported pain of "Tampon Test" (mean of Week 24).
Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
Time Frame
Weeks 1 and 6; Weeks 1 and 24
Other Pre-specified Outcome Measures:
Title
Traditional Chinese Medicine (TCM) Diagnosis Category
Description
TCM Diagnosis Category will be recorded and tracked by the primary investigator to determine if it may be a potential predictor of treatment response.
Time Frame
Week 1
Title
24-hour mean pain score
Description
In a daily pain diary, study participants will be asked to record the level of pain they are experiencing based via the 10-point VAS scale (0 indicates no pain, 10 indicates worst possible pain).
Time Frame
Baseline, Weeks 6, 12, and 24
Title
Frequency of intercourse
Description
In a daily pain diary, study participants will be asked to record if they engaged in intercourse within the last 24 hours.
Time Frame
Baseline, Weeks 6, 12, and 24
Title
Intensity of Intercourse pain
Description
In a daily pain diary, study participants will be asked to record the level of pain they are experienced with intercourse based via the 10-point VAS scale (0 indicates no pain, 10 indicates worst possible pain).
Time Frame
Baseline, Weeks 6, 12, and 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Literate, English speaking, premenopausal, women meeting Friedrich's criteria for Provoked, localized vulvodynia
Reported introital dyspareunia longer than three months duration;
Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with cotton swab test and Tampon Test;
Able to insert an Original Regular Tampax™ tampon.
Exclusion Criteria:
Co-existing conditions leading to dyspareunia including generalized unprovoked vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or genital infection (e.g. herpes simplex virus or yeast infection).
Pregnant or postpartum and breastfeeding;
Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last six months. If taken for longer, must be on a stable dose for at least six months and still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs) are allowed;
Postmenopausal as defined by surgical or natural menopause (no menses for 12 months);
Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen for longer than three months duration;
Must be able to refrain from other treatments for PLV including non-traditional options (e.g. other medications, physical therapy, sex therapy, acupuncture, naturopathic remedies) during the course of the study (6 months).
Use of SNRIs, lidocaine, or acupuncture within the last three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee E Hullender Rubin, DAOM
Organizational Affiliation
Oregon College of Oriental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Research Unit; Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31592976
Citation
Hullender Rubin LE, Mist SD, Schnyer RN, Chao MT, Leclair CM. Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study. J Low Genit Tract Dis. 2019 Oct;23(4):279-286. doi: 10.1097/LGT.0000000000000489.
Results Reference
result
Links:
URL
http://journals.lww.com/jlgtd/Citation/2017/10001/Abstracts.1.aspx
Description
Related Info
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Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
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