Chuna Manual Treatment for Patients With Primary Dysmenorrhea Primary Dysmenorrhea

NCT ID: NCT06517108

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2025-03-20

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chuna therapy

15 patients with chuna therapy

Group Type: EXPERIMENTAL

Chuna therapy

Intervention Type: 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.

Physical therapy

15 patients with physical therapy

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: 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.

Interventions

Chuna therapy

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.

Intervention Type: PROCEDURE

Physical therapy

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunah Kim, KMD

Role: PRINCIPAL_INVESTIGATOR

Daejeon Jaseng Hospital of Korean Medicine

Locations

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

JS-CT-2021-18

Identifier Type: -

Identifier Source: org_study_id