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IRCT20241220064105N4 IRCT 2025-06-02 Muhammad Instituite of Rehabilitation Sciences, Multan Diclofenac Potassium Gel with and without Transcutaneous Electrical Nerve Stimulation in Primary Dysmenorrhea Effectiveness of Diclofenac Potassium Gel with and without Transcutaneous Electrical Nerve Stimulation in Primary Dysmenorrhea 2025-01-14 anticipated 376 Complete https://irct.ir/trial/83810 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using the lottery method will be applied at the individual level without stratification. Participants will draw sealed slips to determine group allocation. Identical numbered white boxes will conceal treatment, and codes will be held by the principal investigator to maintain allocation concealment, Blinding description: Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness. N/A Primary dysmenorrhea. Intervention 1: Intervention group: Transcutaneous electrical nerve stimulation (TENS) therapy will be administered alongside diclofenac potassium gel. Transcutaneous electrical nerve stimulation (TENS) will be applied using a high-frequency setting of 80–100 hertz (Hz), a pulse duration of approximately 100 microseconds, and the intensity will be adjusted to produce a strong but comfortable tingling sensation without causing muscle contraction. Each session of transcutaneous electrical nerve stimulation (TENS) will last for 20 to 30 minutes and will be conducted two to three times per day during the 2 to 3-day treatment period. Intervention 2: Control group: will be treated with 6% Diclofenac Potassium gel alone, the gel will apply to the lower abdomen and/or lower back at a dose of 2 to 4 grams per application, two to four times daily, beginning at the onset of menstrual pain and continuing for up to three days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is N-A
public Maliha Khalid Khan
Bosan Road
multan Pakistan 660000 +92 312 6862130 malihatareen1997@gmail.com Muhammad Instituite of Medical and Allied Sciences, Multan scientific Komal Ammar Bukhari
Bosan Road
multan Pakistan 66000 +92 314 6361728 komalbukhari608@gmail.com Muhammad Institute of Medical Sciences and Rehabilitation Pakistan (18-45 years) primary or secondary dysmenorrhea Regular menstrual cycles (21-35days) Moderate to severe menstrual pain Participants were females experiencing PD not using hormonal contraception. 18 years 45 years Female Pregnancy Females with bleeding disorders Breast feeding Uterine fibroids. Adenomyosis Endometriosis Pelvic inflammatory disease Menstrual disorder Hormonal contraceptive use Surgery or Procedures N94.6 Dysmenorrhea, unspecified Rehabilitation Rehabilitation Intervention group: Transcutaneous electrical nerve stimulation (TENS) therapy will be administered alongside diclofenac potassium gel. Transcutaneous electrical nerve stimulation (TENS) will be applied using a high-frequency setting of 80–100 hertz (Hz), a pulse duration of approximately 100 microseconds, and the intensity will be adjusted to produce a strong but comfortable tingling sensation without causing muscle contraction. Each session of transcutaneous electrical nerve stimulation (TENS) will last for 20 to 30 minutes and will be conducted two to three times per day during the 2 to 3-day treatment period Control group: will be treated with 6% Diclofenac Potassium gel alone, the gel will apply to the lower abdomen and/or lower back at a dose of 2 to 4 grams per application, two to four times daily, beginning at the onset of menstrual pain and continuing for up to three days Pain. Timepoint: The primary outcome will be measured before the intervention and at 2 and 4 weeks after the intervention. Method of measurement: WALIDD Scale. Muhammad Instituite of Rehabilitation Sciences, Multan Approved 2024-12-14 The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences Bosan Road multan punjab Pakistan