Back to resultsThe Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
spine manual therapy
Superficial heat therapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- The wells neuropain clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
spine manual therapy of sacroiliac joint
Superficial heat therapy
Arm Description
The group which treats spine manual therapy of sacroiliac joint
Group treated with superficial heat therapy for 20 minutes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Visual analog scale
On a line consisting of 10 cm, 0 at either end represents 'no pain' and 10 represents 'worst pain'.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05752864
Brief Title
The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
spine manual therapy of sacroiliac joint
Arm Type
Experimental
Arm Description
The group which treats spine manual therapy of sacroiliac joint
Arm Title
Superficial heat therapy
Arm Type
Active Comparator
Arm Description
Group treated with superficial heat therapy for 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
spine manual therapy
Intervention Description
The manual treatment method applied to the sacroiliac joint used high-velocity, low amplitude (HVLA).
Intervention Type
Device
Intervention Name(s)
Superficial heat therapy
Intervention Description
In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
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.
Time Frame
Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale
Description
On a line consisting of 10 cm, 0 at either end represents 'no pain' and 10 represents 'worst pain'.
Time Frame
Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Title
Pressure pain threshold
Description
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.
Time Frame
Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Title
Menstrual distress questionnaire
Description
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.
Time Frame
Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungeon Park, Ph.D candidate
Organizational Affiliation
The wells neuropain clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The wells neuropain clinic
City
Seoul
ZIP/Postal Code
05557
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea
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