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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Real dry needling will be applied to the pelvic floor, hip and lower back muscles.
Sham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles.
Research Center of the Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
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.
Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adherence to treatment protocol
a. To determine feasibility by assessing adherence to treatment sessions.
Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Retention rate
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)
Adverse effects
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)
Adverse effects
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)
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
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: After treatment session 3 (week 3)
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.
Time frame: Post-treatment assessment (2-week post-treatment)
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.
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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).
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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).
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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).
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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).
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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).
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in quality of life in the domains associated with chronic pelvic pain
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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)
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.
Time frame: Baseline to Post-treatment assessement (2-week post-treatment)
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).
Time frame: Post-treatment assessment (2-week post-treatment)
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.
Time frame: Post-treatment assessment (2-week post-treatment)
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? ''
Time frame: Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle stiffness
To explore changes in pelvic floor muscle stiffness (Shearwave elastography)
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle function
To explore changes in pelvic floor muscle function (Dynamometric speculum)
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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.
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pressure pain threshold
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)