Chuna Manual Treatment for Patients With Primary Dysmenorrhea Primary Dysmenorrhea

NCT06517108 | Completed DMC

• 1 other identifier: JS-CT-2021-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Chuna; Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• EuroQol Visual Analogue Scale, EQ-VAS

  At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)

• Modified pain scale

  At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)

• Short Form McGill Pain Questionnaire, SF-MPQ

  At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)

• Positive and Negative Affect Schedule, PANAS

  At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)

• EuroQol-5 Dimension, EQ-5D-5L

  At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)

Study Arms (2)

Chuna therapy

EXPERIMENTAL

15 patients with chuna therapy

Procedure: Chuna therapy

Physical therapy

ACTIVE COMPARATOR

15 patients with physical therapy

Procedure: Physical therapy

Interventions

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.

Chuna therapy

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.

Physical therapy

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Sunah Kim, KMD

  Daejeon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: January 10, 2022
• Primary Completion: November 15, 2024
• Study Completion: March 20, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)