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Dry Needling for Provoked Vestibulodynia

Primary Purpose

Provoked Vestibulodynia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Real Dry needling
Non penetrating dry needling
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Provoked Vestibulodynia focused on measuring Dyspareunia, Vulvodynia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of provoked vestibulodynia according to a standardised gynaecologic exam Moderate to severe pain (≥ 5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months Exclusion Criteria: Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy) Post-menopausal state Actual or past pregnancy in the last year Urogynecological conditions (e.g., pelvic organs prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months) Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organs prolapse surgery) Prior use of dry needling or acupuncture treatments Fear of needles or any contraindication to needling therapies Changes of medication that could influence pain perception (e.g., analgesic, antidepressant) in the last 3 months Other medical conditions that could interfere with the study

Sites / Locations

  • Research Center of the Centre Hospitalier Universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental: Real Dry needling

Sham: Non penetrating dry needling

Arm Description

1 dry needling treatment per week for 6 consecutive weeks

1 non penetrating dry needling per week for 6 consecutive weeks

Outcomes

Primary Outcome Measures

Adherence to treatment sessions
a. To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Adherence to treatment protocol
a. To determine feasibility by assessing adherence to treatment sessions.
Retention rate
a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled
Adverse effects
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Adverse effects
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Recruitment rate
a. To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented
Intervention Acceptability Questionnaire
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Intervention Acceptability Questionnaire
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Intervention Acceptability Questionnaire
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.

Secondary Outcome Measures

Change in pain intensity during intercourse
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS)). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Change in pain quality
To explore changes on the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Ranging from 0 to 78, higher scores mean worst outcome (higher pain).
Change in pain catastrophizing
To explore changes on pain catastrophizing (Pain catastrophizing scale (PCS)). Ranging from 0 to 52, higher scores mean worse outcome (higher pain catastrophizing).
Change in fear of pain
To explore changes in fear of pain (Pain anxiety Symptoms Scale (PASS-20). Ranging from 0 to 100, higher scores mean worse outcome (higher fear of pain).
Change in sexual function
To explore changes in sexual function (Female Sexual Function Index - FSFI). Ranging from 2 to 36, lower scores mean wort outcome (low sexual function).
Change in sexual distress
To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Ranging from 0 to 52, higher scores mean worse outcome (higher sexually related distress).
Change in quality of life in the domains associated with chronic pelvic pain
To explore changes in quality of life Pelvic Pain Impact Questionnaire (PPIQ). Ranging from 0 to 32, higher scores mean worse outcome (less quality of life associated with pelvic pain).
Severity of symptoms related with central sensitization
To explore changes in symptoms related to central sensitization (Central Sensitization Inventory). Ranging from 0 to 100, a higher scores indicates higher central sensitivity.
Satisfaction with treatment
To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (complete satisfied).
Patient's global impression of change
To examine patient self-reported improvement (Patient's Global Impression of Change). Ranging from "very much worse" to "very much improved" on a 7-point scale.
Blinding effectiveness
To assess the feasibility of maintaining blinding to group allocation for the participants. Evaluated by asking the question: ''What treatment do you think you have received? ''
Changes in pelvic floor muscle stiffness
To explore changes in pelvic floor muscle stiffness (Shearwave elastography)
Changes in pelvic floor muscle function
To explore changes in pelvic floor muscle function (Dynamometric speculum)
Changes in pain at palpation
To explore changes at intravaginal palpation of the internal obturators and the levator ani muscles following a standardized procedure (Numerical Rating Scale). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Changes in pressure pain threshold
To explore changes in pressure pain threshold if predetermined areas of the pelvis (Wagner algometer)

Full Information

First Posted
February 27, 2023
Last Updated
April 18, 2023
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT05797480
Brief Title
Dry Needling for Provoked Vestibulodynia
Official Title
Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized and controlled study investigating the feasibility and acceptability of a dry needling treatment for women suffering from provoked vestibulodynia. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses of provoked vestibulodynia. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. The sham group will receive 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain intensity and quality, pain during palpation and pressure pain threshold, psychosexual variables, perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness and function.
Detailed Description
Up to 18% of reproductive-aged women experience chronic pain in the vulvar region during sexual intercourse. This chronic pain condition is called vulvodynia. The main subtype of this pain condition is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening when there is a pressure applied to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD suffer from sexual dysfunctions, psychological distress and worsened quality of life. The treatment options currently available are still quite limited and some women still experience pain despite undertaking all options available. We, therefore, proposed a randomized and controlled study to investigate the feasibility and acceptability of a dry needling treatment for women suffering from PVD. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. Participants and evaluators will be blinded. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. For the first three sessions, the dry needling/or sham techniques will be aimed at the muscles of the trunk, lower back, hips and SI joints. For the last 3 treatment sessions, the dry needling/or sham techniques will aimed at the pelvic floor muscles. The sham group will receive the same 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and 2 weeks post-treatment and will include: feasibility (adherence to treatment, retention rates, adverse effects, recruitment rates and data on dry needling (needles, # of insertions, pain related) and acceptability variables. Secondary outcomes will include pain intensity during intercourse (numeric scale) and quality (McGill pain questionnaire), pain during palpation and pressure pain threshold (Pressure algometer), psychosexual variables (sexual distress and sexual function), change in pain catastrophizing, change in quality of life in domains associated with chronic pelvic pain (Pelvic Pain Impact questionnaire, severity of symptoms related to central sensitization), perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness (shearwave elastography and dynamometric speculum)and function (dynamometric speculum), blinding efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Vestibulodynia
Keywords
Dyspareunia, Vulvodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Baseline evaluation - Randomization to real dry needling or sham dry needling (6 sessions for 6 consecutive weeks) - post-treatment evaluation (2-week post-treatment)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Real Dry needling
Arm Type
Experimental
Arm Description
1 dry needling treatment per week for 6 consecutive weeks
Arm Title
Sham: Non penetrating dry needling
Arm Type
Sham Comparator
Arm Description
1 non penetrating dry needling per week for 6 consecutive weeks
Intervention Type
Other
Intervention Name(s)
Real Dry needling
Other Intervention Name(s)
Needling
Intervention Description
Real dry needling will be applied to the pelvic floor, hip and lower back muscles.
Intervention Type
Other
Intervention Name(s)
Non penetrating dry needling
Other Intervention Name(s)
Sham, Control
Intervention Description
Sham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles.
Primary Outcome Measure Information:
Title
Adherence to treatment sessions
Description
a. To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Time Frame
Through treatment completion (session 1 to 6; 6 weeks of treatment)
Title
Adherence to treatment protocol
Description
a. To determine feasibility by assessing adherence to treatment sessions.
Time Frame
Through treatment completion (session 1 to 6; 6 weeks of treatment)
Title
Retention rate
Description
a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Adverse effects
Description
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Time Frame
Through treatment completion (session 1 to 6; 6 weeks of treatment)
Title
Adverse effects
Description
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Time Frame
Post-treatment assessment (2-week post-treatment)
Title
Recruitment rate
Description
a. To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented
Time Frame
Baseline
Title
Intervention Acceptability Questionnaire
Description
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Time Frame
Baseline
Title
Intervention Acceptability Questionnaire
Description
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Time Frame
After treatment session 3 (week 3)
Title
Intervention Acceptability Questionnaire
Description
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Time Frame
Post-treatment assessment (2-week post-treatment)
Secondary Outcome Measure Information:
Title
Change in pain intensity during intercourse
Description
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS)). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Change in pain quality
Description
To explore changes on the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Ranging from 0 to 78, higher scores mean worst outcome (higher pain).
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Change in pain catastrophizing
Description
To explore changes on pain catastrophizing (Pain catastrophizing scale (PCS)). Ranging from 0 to 52, higher scores mean worse outcome (higher pain catastrophizing).
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Change in fear of pain
Description
To explore changes in fear of pain (Pain anxiety Symptoms Scale (PASS-20). Ranging from 0 to 100, higher scores mean worse outcome (higher fear of pain).
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Change in sexual function
Description
To explore changes in sexual function (Female Sexual Function Index - FSFI). Ranging from 2 to 36, lower scores mean wort outcome (low sexual function).
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Change in sexual distress
Description
To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Ranging from 0 to 52, higher scores mean worse outcome (higher sexually related distress).
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Change in quality of life in the domains associated with chronic pelvic pain
Description
To explore changes in quality of life Pelvic Pain Impact Questionnaire (PPIQ). Ranging from 0 to 32, higher scores mean worse outcome (less quality of life associated with pelvic pain).
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Severity of symptoms related with central sensitization
Description
To explore changes in symptoms related to central sensitization (Central Sensitization Inventory). Ranging from 0 to 100, a higher scores indicates higher central sensitivity.
Time Frame
Baseline to Post-treatment assessement (2-week post-treatment)
Title
Satisfaction with treatment
Description
To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (complete satisfied).
Time Frame
Post-treatment assessment (2-week post-treatment)
Title
Patient's global impression of change
Description
To examine patient self-reported improvement (Patient's Global Impression of Change). Ranging from "very much worse" to "very much improved" on a 7-point scale.
Time Frame
Post-treatment assessment (2-week post-treatment)
Title
Blinding effectiveness
Description
To assess the feasibility of maintaining blinding to group allocation for the participants. Evaluated by asking the question: ''What treatment do you think you have received? ''
Time Frame
Post-treatment assessment (2-week post-treatment)
Title
Changes in pelvic floor muscle stiffness
Description
To explore changes in pelvic floor muscle stiffness (Shearwave elastography)
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Changes in pelvic floor muscle function
Description
To explore changes in pelvic floor muscle function (Dynamometric speculum)
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Changes in pain at palpation
Description
To explore changes at intravaginal palpation of the internal obturators and the levator ani muscles following a standardized procedure (Numerical Rating Scale). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)
Title
Changes in pressure pain threshold
Description
To explore changes in pressure pain threshold if predetermined areas of the pelvis (Wagner algometer)
Time Frame
Baseline to Post-treatment assessment (2-week post-treatment)

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: Diagnosis of provoked vestibulodynia according to a standardised gynaecologic exam Moderate to severe pain (≥ 5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months Exclusion Criteria: Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy) Post-menopausal state Actual or past pregnancy in the last year Urogynecological conditions (e.g., pelvic organs prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months) Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organs prolapse surgery) Prior use of dry needling or acupuncture treatments Fear of needles or any contraindication to needling therapies Changes of medication that could influence pain perception (e.g., analgesic, antidepressant) in the last 3 months Other medical conditions that could interfere with the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Roch, M. Sc.
Phone
1-888-463-1835
Ext
18439
Email
melanie.roch@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Morin, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Center of the Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Morin, PhD
Phone
+18193461110
Ext
18439
Email
labomorin@usherbrooke.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Dry Needling for Provoked Vestibulodynia

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