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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.
Menstrual pain is known to be caused by increased tension in the uterine muscles and irregular contractions, and is experienced by 50% of women who menstruate. However, most people control pain with NSAIDs or hormones. Among non-pharmacological treatments, manual therapy is known to control menstrual pain by influencing pain perception and pain-related serological factors. Previous research results have shown that manual therapy using sacroiliac joint correction and high-speed, low-amplitude thrust techniques is effective for menstrual pain. However, there is still no randomized controlled study limited to Chuna therapy. Therefore, the investigators would like to conduct a randomized clinical study to determine the effectiveness and safety of Chuna therapy for primary dysmenorrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chuna therapy | Experimental | 15 patients with chuna therapy |
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| Physical therapy | Active Comparator | 15 patients with physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chuna therapy | Procedure | The chuna therapy group will receive chuna therapy based on the degree of displacement of the lumbar, ilium, sacrum, and cervical vertebrae. The type of weight or treatment is selected based on the clinical judgment of the Korean medicine practitioner (HVLA: high-velocity low-amplitude thrust, drop table manipulation, muscle energy techniques, myofascial release, etc.). The area and number of treatments performed are recorded separately. Thermotherapy is applied as an adjuvant treatment. The treatment will be administered between MCD 8 and MCD 28, twice a week during the 1st and 2nd cycle. The number of treatments can be adjusted depending on the patient's menstrual cycle and degree of displacement. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunah Kim, KMD | Daejeon Jaseng Hospital of Korean Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon Jaseng Hospital of Korean Medicine | Daejeon | 35262 | South Korea |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physical therapy | Procedure | The physical therapy group will receive transcutaneous electrical nerve stimulation (TENS) for about 10 to 15 minutes, and the area and number of times it was administered will be recorded. Thermotherapy is applied as an adjuvant treatment, and the area and number of times it is applied are recorded separately. The treatment will be administered between MCD 8 and MCD 28, twice a week during the 1st and 2nd cycle. The number of treatments can be adjusted depending on the patient's menstrual cycle and degree of displacement. |
|
| 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) |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |