Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-25
SponsorKafrelsheikh University
About this trial
This study aims to investigate the effects of transcutaneous tibial nerve stimulation (TTNS) on women with primary dysmenorrhea (PD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ranges from 20-25 years old.
Body mass index (BMI) doesn't exceed 30 kg/m2.
Patients referred from a Gynecologist with a diagnosis of Primary Dysmenorrhea (PD).
Patients have regular menstrual cycles.
Disqualifiers
Patients diagnosed with gynecological pathology.
Patients taking oral contraceptives or had an intrauterine device implanted.
Patients had bad obstetric situations or diseases that could interfere with participation.
Patients have certain disorders including uncorrected coagulopathies, severe comorbid disorder, cancer in the last 5 years or at present, presence of erosions on the inner aspect of the ankle, severe mental disorders, or neuropathies affecting the lower limb.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous tibial nerve stimulation (TTNS)
Other interventionPatients will receive the transcutaneous tibial nerve stimulation (TTNS) and traditional treatment (Nonsteroidal anti-inflammatory drugs) for three sessions a week for four consecutive weeks.
Traditional treatment (Nonsteroidal anti-inflammatory drugs)
DrugPatients will receive the placebo transcutaneous tibial nerve stimulation (TTNS) and traditional treatment (Nonsteroidal anti-inflammatory drugs) for three sessions a week for four consecutive weeks.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Study group (group A)Experimental treatment 1 intervention
Group B: Control group (group B)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity
Pain Intensity will be assessed using visual Analogue Scale (VAS). VAS consisted of a continuous 10 cm line that represents the pain intensity, ranging from zero; on the left side, which indicates no pain, or discomfort to 10; on the right side, which indicates the worst possible pain he could feel.
Time frame
6 months after the procedureSecondary outcomes
1
Prostaglandin level
Serum Prostaglandin will be measured.
Time frame
6 months after the procedure2
Assessment of Quality of Life
Quality of Life (QOL) will be assessed using the Arabic Version of the Short Form 36 Health Questionnaire. This questionnaire will be used for assessment of QOL. It is made up of 35 items that measure 8 dimensions of health-related QOL. In addition, it includes a change self-assessment item that is not used in scoring. The instrument items cover: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. The higher the score on the SF-36, the better the health.
Time frame
6 months after the procedureSponsors and contacts
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Source ClinicalTrials.gov