Trial record 1 of 36 for:    vulvodynia
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Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oregon College of Oriental Medicine
Sponsor:
Collaborators:
National Vulvodynia Association
Council of Colleges of Acupuncture and Oriental Medicine
Oregon Health and Science University
Information provided by (Responsible Party):
Lee Hullender Rubin, DAOM, LAc, Oregon College of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT01996384
First received: November 18, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Provoked, Localized Vulvodynia
Provoked Vestibulodynia
Vulvar Vestibulitis
Vulvodynia
Procedure: Classical Acupuncture
Procedure: Non-classical acupuncture
Drug: Lidocaine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Provoked, Localized Vulvodynia Treatment With Acupuncture and lidocaine-a Feasibility Pilot Study

Resource links provided by NLM:


Further study details as provided by Oregon College of Oriental Medicine:

Primary Outcome Measures:
  • Tampon Test [ Time Frame: Weeks 1 and 12 study period ] [ Designated as safety issue: No ]

    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 [ Time Frame: Weeks -2, -1, 0, 1, 12 or 13 and 24. ] [ Designated as safety issue: No ]

    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 [ Time Frame: At baseline visit, 6 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 6, 12 and 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
    Assess feasibility by the number of study visits study participants attend.

  • Tampon Test [ Time Frame: Weeks 1 and 6; Weeks 1 and 24 ] [ Designated as safety issue: No ]

    Secondary outcome variables will be to:

    1. 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);
    2. 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);
    3. 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).



Other Outcome Measures:
  • Traditional Chinese Medicine (TCM) Diagnosis Category [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    TCM Diagnosis Category will be recorded and tracked by the primary investigator to determine if it may be a potential predictor of treatment response.

  • 24-hour mean pain score [ Time Frame: Baseline, Weeks 6, 12, and 24 ] [ Designated as safety issue: No ]
    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).

  • Frequency of intercourse [ Time Frame: Baseline, Weeks 6, 12, and 24 ] [ Designated as safety issue: No ]
    In a daily pain diary, study participants will be asked to record if they engaged in intercourse within the last 24 hours.

  • Intensity of Intercourse pain [ Time Frame: Baseline, Weeks 6, 12, and 24 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Classical Acupuncture + Lidocaine
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).
Procedure: Classical Acupuncture
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.
Drug: Lidocaine
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Other Name: 5% Lidocaine cream
Active Comparator: Non-classical acupuncture + lidocaine
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).
Procedure: Non-classical acupuncture
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.
Drug: Lidocaine
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Other Name: 5% Lidocaine cream

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;11
  • 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), anxiolytics, anti-seizure medications). 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996384

Contacts
Contact: Lee E Hullender Rubin, DAOM (503) 249-4868 lrubin@ocom.edu
Contact: Gianou Knox, BS, BA 503) 418-1288 knoxg@ohsu.edu

Locations
United States, Oregon
Women's Health Research Unit; Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Lee E Hullender Rubin, DAOM    503-494-3666    whru@ohsu.edu   
Contact: Gianou Knox    (503) 418-1288    knoxg@ohsu.edu   
Principal Investigator: Lee Hullender Rubin, DAOM         
Sponsors and Collaborators
Oregon College of Oriental Medicine
National Vulvodynia Association
Council of Colleges of Acupuncture and Oriental Medicine
Oregon Health and Science University
Investigators
Principal Investigator: Lee E Hullender Rubin, DAOM Oregon College of Oriental Medicine
  More Information

No publications provided

Responsible Party: Lee Hullender Rubin, DAOM, LAc, Adjunct Research Faculty, Oregon College of Oriental Medicine
ClinicalTrials.gov Identifier: NCT01996384     History of Changes
Other Study ID Numbers: OHSU IRB 9664
Study First Received: November 18, 2013
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Oregon College of Oriental Medicine:
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

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Genital Diseases, Female
Vulvar Diseases
Vulvitis
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 22, 2014