Chuna Manual Treatment for Patients With Primary Dysmenorrhea Primary Dysmenorrhea
NCT Number: NCT06517108
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Dysmenorrhea
Interventions: PROCEDURE: Chuna therapy|PROCEDURE: Physical therapy
Sponsor: Jaseng Medical Foundation
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-10
Completion Date: 2024-12-31
Locations: Daejeon Jaseng Hospital of Korean Medicine, Daejeon, 35262, Korea, Republic of

Summary:
This study is a randomized controlled trial that compares 30 patients with primary dysmenorrhea by assigning them in a 1:1 ratio between patients treated with a Chuna therapy strategy and patients treated with a strategy using physical therapy. The purpose of the study is to confirm the comparative effectiveness of Chuna therapy and physical therapy.

Primary Outcome Measures: Peak dysmenorrhea NRS during menstrual period, The maximum pain intensity during menstruation will be assessed using the NRS. In the NRS, patients choose a number from 0 to 10 that best represents their current level of discomfort (0 being no pain and 10 being the worst pain imaginable)., Screening day(Cycle -1), At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
Secondary Outcome Measures: EuroQol Visual Analogue Scale, EQ-VAS, This assessment tool helps to express how good or bad a patient's health status is by having the patient record the degree of health status they feel on a vertical 100mm line, with one end indicating the worst imaginable health state and the other end indicating the best imaginable health state., At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)|Modified pain scale, The modified pain scale is a scale that defines pain according to work loss and the need for analgesics. It is the sum of the number of days of pelvic pain and use of painkillers, each calculated from 0 to a maximum of 3., At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)|Short Form McGill Pain Questionnaire, SF-MPQ, The main component of the SF-MPQ consists of 15 words (11 sensations, 4 emotions) rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate, or 3 = severe. The three pain scores are obtained as the sum of the intensity values of the selected words. Also included is the current pain intensity (PPI) index and visual analog scale (VAS) from the standard MPQ. The Korean version of SF-MPQ, adapted by Kim Eun-ju, is used., At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)|Positive and Negative Affect Schedule, PANAS, The positive and negative emotion scales developed by Watson et al. consist of a total of 20 questions, including 10 positive emotion scales and 10 negative emotion scales. Evaluate the degree to which each item applies to you on a 5-point scale (0 = not at all, 1 = slightly, 2 = moderately, 3 = a lot, 4 = very much)., At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)|EuroQol-5 Dimension, EQ-5D-5L, It is the most widely used of several indirect measurement methods as a method of indirectly calculating the quality weight of a specific health state using pre-assigned preference scores for each functional level after evaluating the health state from various aspects. The EQ-5D-5L consists of 5 questions. Each question includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Ask about the degree of depression, etc. Each item is weighted according to its level, and an equation for calculating preference scores is presented based on these weights and constants., At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)|Short Form-12 Health Survey version 2, SF-12 v2, Health-related quality of life (HRQoL) The evaluation questionnaire consists of 12 questions spanning 8 areas (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). It usually takes less than 5 minutes to complete, and higher scores indicate better health-related quality of life. SF-12 is used to evaluate the functional health and well-being of patients and healthy people., At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)|Patient Global Impression of Change, PGIC, This is a method that allows the patient to subjectively evaluate the degree of improvement on a 7-level scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse., At the first visit of Cycle 3, 5 (each cycle is 28 days)