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

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 Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Behavioral: spine manual therapy; Device: Superficial heat therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05557
    • The wells neuropain clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: spine manual therapy of sacroiliac joint; The group which treats spine manual therapy of sacroiliac joint	Behavioral: spine manual therapy; The manual treatment method applied to the sacroiliac joint used high-velocity, low amplitude (HVLA).
Active Comparator: Superficial heat therapy; Group treated with superficial heat therapy for 20 minutes	Device: Superficial heat therapy; In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sahmyook University
• Investigators: Principal Investigator: Sungeon Park, Ph.D candidate, The wells neuropain clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 24, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Menstruation Disturbances; Pelvic Pain; Abdominal Pain; Dysmenorrhea
• Other Study ID Numbers: SYU 2023-01-002-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No