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NCT Number: NCT05797480

Dry Needling for Provoked Vestibulodynia

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.

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Key information

Conditions

Provoked Vestibulodynia Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Research Center of the Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real dry needling

Other

Real dry needling will be applied to the pelvic floor, hip and lower back muscles.

Other names: Needling

Non penetrating dry needling

Other

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

Other names: Sham, Control

Primary outcomes

  1. Adherence to treatment sessions

    Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)

    a. To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.

  2. Adherence to treatment protocol

    Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)

    a. To determine feasibility by assessing adherence to treatment sessions.

  3. Retention rate

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled

  4. Adverse effects

    Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)

    a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.

  5. Adverse effects

    Time frame: Post-treatment assessment (2-week post-treatment)

    a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.

  6. Recruitment rate

    Time frame: Baseline

    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

  7. Intervention Acceptability Questionnaire

    Time frame: Baseline

    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.

  8. Intervention Acceptability Questionnaire

    Time frame: After treatment session 3 (week 3)

    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.

  9. Intervention Acceptability Questionnaire

    Time frame: Post-treatment assessment (2-week post-treatment)

    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 outcomes

  1. Change in pain intensity during intercourse

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    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.

  2. Change in pain quality

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    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).

  3. Change in pain catastrophizing

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    To explore changes on pain catastrophizing (Pain catastrophizing scale (PCS)). Ranging from 0 to 52, higher scores mean worse outcome (higher pain catastrophizing).

  4. Change in fear of pain

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    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).

  5. Change in sexual function

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    To explore changes in sexual function (Female Sexual Function Index - FSFI). Ranging from 2 to 36, lower scores mean wort outcome (low sexual function).

  6. Change in sexual distress

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    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).

  7. Change in quality of life in the domains associated with chronic pelvic pain

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    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).

  8. Severity of symptoms related with central sensitization

    Time frame: Baseline to Post-treatment assessement (2-week post-treatment)

    To explore changes in symptoms related to central sensitization (Central Sensitization Inventory). Ranging from 0 to 100, a higher scores indicates higher central sensitivity.

  9. Satisfaction with treatment

    Time frame: Post-treatment assessment (2-week post-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).

  10. Patient's global impression of change

    Time frame: Post-treatment assessment (2-week post-treatment)

    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.

  11. Blinding effectiveness

    Time frame: Post-treatment assessment (2-week post-treatment)

    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? ''

  12. Changes in pelvic floor muscle stiffness

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    To explore changes in pelvic floor muscle stiffness (Shearwave elastography)

  13. Changes in pelvic floor muscle function

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    To explore changes in pelvic floor muscle function (Dynamometric speculum)

  14. Changes in pain at palpation

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    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.

  15. Changes in pressure pain threshold

    Time frame: Baseline to Post-treatment assessment (2-week post-treatment)

    To explore changes in pressure pain threshold if predetermined areas of the pelvis (Wagner algometer)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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