Primary DysmenorrheaNCT06517108
Chuna Manual Treatment for Patients With Primary Dysmenorrhea Primary Dysmenorrhea
A study testing Chuna therapy and Physical therapy in people with Primary Dysmenorrhea, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 49 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Chuna therapy and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2022to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
About this study
Official title: The Efficacy and Safety of Chuna Manual Treatment for Patients With Primary Dysmenorrhea: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Chuna therapy, Physical therapy
- Keywords
- Chuna, Dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chuna therapyProcedure or surgery
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 therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Chuna therapy | Experimental | 15 patients with chuna therapy Receives: Procedure: Chuna therapy |
| Physical therapy | Active comparator | 15 patients with physical therapy Receives: Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the first visit of Cycle 3, 5 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start10 Jan 2022
- Primary completion15 Nov 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunah Kim, KMD, Principal investigator, Daejeon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517108
- Sponsor's protocol ID
- JS-CT-2021-18
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Chuna Manual Treatment for Patients With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06517108
- Acronym / sponsor ID
- JS-CT-2021-18
- Conditions
- Primary Dysmenorrhea
- Keywords
- Chuna, Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chuna therapy | Experimental | Procedure: Chuna therapy15 patients with chuna therapy |
| Physical therapy | Active comparator | Procedure: Physical therapy15 patients with physical therapy |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chuna therapyThe 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. | Procedure or surgery | Chuna therapy |
| Physical therapyThe 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. | Procedure or surgery | Physical therapy |
Primary outcome
Peak dysmenorrhea NRS during menstrual period
Time frame: Screening day(Cycle -1), At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
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).
7 secondary outcomes
EuroQol Visual Analogue Scale, EQ-VAS
Time frame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
Modified pain scale
Time frame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
Short Form McGill Pain Questionnaire, SF-MPQ
Time frame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
Positive and Negative Affect Schedule, PANAS
Time frame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
EuroQol-5 Dimension, EQ-5D-5L
Time frame: 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
Time frame: At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
Patient Global Impression of Change, PGIC
Time frame: At the first visit of Cycle 3, 5 (each cycle is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
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Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunah Kim, KMD principal investigator
Daejeon Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chuna therapy and Physical therapy in people with Primary Dysmenorrhea, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak dysmenorrhea NRS during menstrual period (time frame: Screening day(Cycle -1), At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.