Clinical trial NCT06517108: Chuna Manual Treatment for Patients with Primary Dysmenorrhea Primary Dysmenorrhea
Official title: The Efficacy and Safety of Chuna Manual Treatment for Patients with Primary Dysmenorrhea: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Chuna
Dysmenorrhea
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients whose menstrual pain is NRS 5 or higher during the last 3 months due to primary dysmenorrhea
* Patients who are between 14 and 49 years of age
* Patients whose cycle has been regular between 21 and 40 days for the past 3 months
* Patients who agree to participate in clinical research and provide written test subject consent

Exclusion Criteria:

* Patients whose cause of menstrual pain is determined to be an organic problem (uterine fibroids, adenomyosis, endometriosis, etc.) rather than a primary cause.
* Patients who have taken oral contraceptives or other hormonal therapy within the past 3 months.
* Patients diagnosed with other chronic diseases (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results.
* Patients who are currently taking steroids, immunosuppressants, drugs for mental illness, or other drugs that may affect the results of the study.
* Patients for whom manual therapy is inappropriate or unsafe: history of lumbar fusion or pelvic girdle surgery, spinal fracture, or severe instability.
* Pregnant women, those planning to become pregnant within 6 months, and those planning to take hormones such as oral contraceptives.
* Patients who finished participating in another clinical study less than 1 month ago, or who plan to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection.
* Patients who find it difficult to fill out the consent form for research participation.
* Other cases where participation in clinical research is deemed difficult by the researcher.

Primary outcomes:
measure: Peak dysmenorrhea NRS during menstrual period
timeFrame: Screening day(Cycle -1), At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
Secondary outcomes:
measure: EuroQol Visual Analogue Scale, EQ-VAS
timeFrame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
measure: Modified pain scale
timeFrame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
measure: Short Form McGill Pain Questionnaire, SF-MPQ
timeFrame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
measure: Positive and Negative Affect Schedule, PANAS
timeFrame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
measure: EuroQol-5 Dimension, EQ-5D-5L
timeFrame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
measure: Short Form-12 Health Survey version 2, SF-12 v2
timeFrame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
measure: Patient Global Impression of Change, PGIC
timeFrame: At the first visit of Cycle 3, 5 (each cycle is 28 days)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Sunah Kim, KMD
role: PRINCIPAL_INVESTIGATOR
References: