The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752864
• Other study ID #: SYU 2023-01-002-002
• Status: Completed
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2023
• Source: Sahmyook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Behavioral:
• spine manual therapy
The manual treatment method applied to the sacroiliac joint used high-velocity, low amplitude (HVLA).

Device:
• Superficial heat therapy
In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.

Locations

Country	Name	City	State
Korea, Republic of	The wells neuropain clinic	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Secondary	Visual analog scale	On a line consisting of 10 cm, 0 at either end represents 'no pain' and 10 represents 'worst pain'.	Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Secondary	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.	Change from baseline after intervention at 4 weeks, follow-up at 4 weeks
Secondary	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.	Change from baseline after intervention at 4 weeks, follow-up at 4 weeks