Dry Needling for Provoked Vestibulodynia

Provoked Vestibulodynia Clinical Trial

Official title:

Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797480
• Other study ID #: 2023-4686
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Université de Sherbrooke
• Contact: Melanie Roch, M. Sc.
• Phone: 1-888-463-1835
• Email: melanie.roch[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Other:
• Real Dry needling
Real dry needling will be applied to the pelvic floor, hip and lower back muscles.
• Non penetrating dry needling
Sham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles.

Locations

Country	Name	City	State
Canada	Research Center of the Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through treatment completion (session 1 to 6; 6 weeks of treatment)
Primary	Adherence to treatment protocol	a. To determine feasibility by assessing adherence to treatment sessions.	Through treatment completion (session 1 to 6; 6 weeks of treatment)
Primary	Retention rate	a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled	Baseline to Post-treatment assessment (2-week post-treatment)
Primary	Adverse effects	a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.	Through treatment completion (session 1 to 6; 6 weeks of treatment)
Primary	Adverse effects	a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.	Post-treatment assessment (2-week post-treatment)
Primary	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	Baseline
Primary	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.	Baseline
Primary	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.	After treatment session 3 (week 3)
Primary	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.	Post-treatment assessment (2-week post-treatment)
Secondary	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.	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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).	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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).	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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).	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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).	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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).	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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).	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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.	Baseline to Post-treatment assessement (2-week post-treatment)
Secondary	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).	Post-treatment assessment (2-week post-treatment)
Secondary	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.	Post-treatment assessment (2-week post-treatment)
Secondary	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? ''	Post-treatment assessment (2-week post-treatment)
Secondary	Changes in pelvic floor muscle stiffness	To explore changes in pelvic floor muscle stiffness (Shearwave elastography)	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	Changes in pelvic floor muscle function	To explore changes in pelvic floor muscle function (Dynamometric speculum)	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	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.	Baseline to Post-treatment assessment (2-week post-treatment)
Secondary	Changes in pressure pain threshold	To explore changes in pressure pain threshold if predetermined areas of the pelvis (Wagner algometer)	Baseline to Post-treatment assessment (2-week post-treatment)