Vulvodynia (Vd) is chronic functional vulvar pain, with prevalence of 3-16% and unclear etiopathology. Although Vd significantly deteriorates quality of life, the problem is marginalized, no pharmacologic treatment standards exist. Naltrexone hydrochloride is a specific opioid antagonist with slight agonist activity. There is growing body of evidence supporting the effectiveness of low-dose naltrexone (LDN) in different types of chronic pain. The main goal of this trial is to test the effect of LDN on pain perception and quality of life in women with different types of Vd. Half of the study population receives LDN and the remaining patients take placebo, according to randomization list. This RTC is quadruplet blinded.
In this Randomized Controlled Trial the effectiveness of LDN in reducing chronic pain and improvement of quality of life in women with provoked, spontaneous or mixed vulvodynia is assessed on the basis of the test results recommended according to IMMPACT protocol, compared to the placebo arm. Patients remain in the study for 6 months (4 months of treatment with LDN or placebo). There are 5 visits by a gynecologist (diagnosis of vulvodynia, inclusion and exclusion criteria, randomization), nurse, psychologist and physiotherapist: screening, randomization, control telephone visit, final visit and telephone summary visit. Pain perception and quality of life estimation is reported by the patient in e-diary, validated psychology questionnaires are fulfilled and physical examination acc. Fascial Manipulation (CFMS) L. Stecco method is performed. Tolerability of LDN therapy will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
treatment of vulvodynia
Terpa Limited Liability Company Limited Partnership
Lublin, Poland
RECRUITINGTreatment effectiveness - change in pain intensity
measured by 11-point NRS scale based on spontaneously experienced vulvar and vaginal pain and during vaginal penetration
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Treatment effectiveness - change in type and severity of pain
measured by McGill Questionnaire (SF-MPQ)
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Treatment effectiveness - change in emotional functioning
Beck Depression Inventory (BDI-II)
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Patient's satisfaction
measured by 11-point Lickert scale
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Treatment tolerability
Assessment of the tolerability of LDN therapy based on the assessment of side effects and adverse events
Time frame: throughout the treatment period (from VISIT 2 to VISIT 4) assessed for 4 months
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