Primary DysmenorrheaNCT05752864
The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
A study testing spine manual therapy and Superficial heat therapy in people with Primary Dysmenorrhea, run by Sahmyook University at 1 site in South Korea.
Trial summary
Disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves. The sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea. Read more about this study
- Who is it for?
- Ages 20 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- spine manual therapy and Superficial heat therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2023to 30 Aug 2023
- 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 20 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 20-29
- Regular menstrual cycle (24-32 days)
- Those who have had symptoms of primary dysmenorrhea for at least 1 year
- Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
- The body mass index is between 20-30
- Positive reaction to Gillet test
Who cannot join
- pelvic inflammatory disease
- uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
- Those who have used an intrauterine contraceptive device
- Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
Trial locations and contacts
1 site in 1 country.
About this study
Disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves.
The sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea.
In this study, by applying spinal manual threapty threapty to the sacroiliac joint in women in their 20s with primary dysmenorrhea, we tried to present an effective treatment method by evaluating the function of the autonomic nervous system and confirming the occurrence of pain in the lower abdomen.
- Conditions
- Primary Dysmenorrhea
- Being tested
- spine manual therapy, Superficial heat therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine manual therapyBehavioural
The manual treatment method applied to the sacroiliac joint used high-velocity, low amplitude (HVLA).
Superficial heat therapyDevice
In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
| Study group | Role | What they receive |
|---|---|---|
| spine manual therapy of sacroiliac joint | Experimental | The group which treats spine manual therapy of sacroiliac joint Receives: Behavioral: spine manual therapy |
| Superficial heat therapy | Active comparator | Group treated with superficial heat therapy for 20 minutes Receives: Device: Superficial heat therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Autonomic nervous system balance tester (SA3000new, Medicore Co. Korea) was used. The subjects placed electrodes on three areas (left arm, left leg, right leg) while lying down and performed for 3 minutes.
Measured: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Secondary outcomes (3)
Visual analog scale
On a line consisting of 10 cm, 0 at either end represents 'no pain' and 10 represents 'worst pain'.
Measured: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Pressure pain threshold
The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. With the participant seated comfortably, the examiner identified the sacroiliac joint and applied pressure with the algometer perpendicular to the skin surface until the participant made an "Ah" sound.
- Lower pressure pain thresholds indicate higher sensitivity to pressure and a lower pain tolerance.
- Higher pressure pain thresholds suggest lower sensitivity and a higher pain tolerance.
Measured: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Menstrual distress questionnaire
The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical menstrual cycle symptoms. The MDQ can differentiate between cyclical and non-cyclical changes in somatic symptoms, mood and behavior, and arousal.
-The measured scores range from 0 to 185; higher scores indicate severe dysmenorrhea symptoms.
Measured: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start30 Apr 2023
- Primary completion30 Jun 2023
- Study completion30 Aug 2023
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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
- Investigators
- Sungeon Park, Ph.D candidate, Principal investigator, The wells neuropain clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752864
- Sponsor's protocol ID
- SYU 2023-01-002-002
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05752864
- Acronym / sponsor ID
- SYU 2023-01-002-002
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 3 Mar 2023 (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.
Disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves.
The sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea.
In this study, by applying spinal manual threapty threapty to the sacroiliac joint in women in their 20s with primary dysmenorrhea, we tried to present an effective treatment method by evaluating the function of the autonomic nervous system and confirming the occurrence of pain in the lower abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spine manual therapy of sacroiliac joint | Experimental | Behavioral: spine manual therapyThe group which treats spine manual therapy of sacroiliac joint |
| Superficial heat therapy | Active comparator | Device: Superficial heat therapyGroup treated with superficial heat therapy for 20 minutes |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between the ages of 20-29
- Regular menstrual cycle (24-32 days)
- Those who have had symptoms of primary dysmenorrhea for at least 1 year
- Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
- The body mass index is between 20-30
Key exclusion criteria (4 listed)
- pelvic inflammatory disease
- uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
- Those who have used an intrauterine contraceptive device
- Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
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 |
|---|---|---|
| spine manual therapyThe manual treatment method applied to the sacroiliac joint used high-velocity, low amplitude (HVLA). | Behavioural | spine manual therapy of sacroiliac joint |
| Superficial heat therapyIn the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy. | Device | Superficial heat therapy |
Primary outcome
Heart Rate Variability
Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Autonomic nervous system balance tester (SA3000new, Medicore Co. Korea) was used. The subjects placed electrodes on three areas (left arm, left leg, right leg) while lying down and performed for 3 minutes.
3 secondary outcomes
Visual analog scale
Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Pressure pain threshold
Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Menstrual distress questionnaire
Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
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 27 Dec 2023.
- Individual participant dataSharing planned: Yes
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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.
Sungeon Park, Ph.D candidate principal investigator
The wells neuropain clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spine manual therapy and Superficial heat therapy in people with Primary Dysmenorrhea, run by Sahmyook University 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 6 inclusion and 4 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 27 Dec 2023. 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?
Heart Rate Variability (time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks). 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 27 Dec 2023.