Kafrelsheikh University (Faculty of Physical Therapy)
Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt
Location status: Recruiting
NCT Number: NCT07352982
This study aims to investigate the effects of transcutaneous tibial nerve stimulation (TTNS) on women with primary dysmenorrhea (PD).
Interested in participating?
Request Info20 year–25 year
Female
Interventional
Not applicable
Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt
Location status: Recruiting
Dysmenorrhea is defined as painful menstrual cramps of uterine origin, and considered as one of the most common gynecological disorders among females of childbearing age.
Primary dysmenorrhea (PD) typically manifests within 6-12 months following menarche. It is not associated with organic lesions but is primarily attributed to uterine smooth muscle spasms and vasoconstriction, which are induced by elevated prostaglandin levels.
Additionally, the use of transcutaneous tibial nerve stimulation (TTNS), which consists of the stimulation of the posterior tibial nerve in the superomedial region of the ankle, may be a promising treatment option. The hypogastric sympathetic plexus (L4-L5) and the pelvic parasympathetic plexus (S2-S4) have the same medullar level as the posterior tibial nerve (L4-S3). Thus, inhibitory and excitatory impulses that control the function of the pelvic viscera at the level of the spinal cord can be rebalanced with their stimulation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive the transcutaneous tibial nerve stimulation (TTNS) and traditional treatment (Nonsteroidal anti-inflammatory drugs) for three sessions a week for four consecutive weeks.
Patients 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.
Time frame: 6 months after the procedure
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 procedure
Serum Prostaglandin will be measured.
Time frame: 6 months after the procedure
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.
Interested in participating?
Request InfoKafrelsheikh University
Other
Effect of Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
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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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