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

NCT05752864 | Completed

• 1 other identifier: SYU 2023-01-002-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual analog scale

  Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

• Pressure pain threshold

  Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

• Menstrual distress questionnaire

  Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

Study Arms (2)

spine manual therapy of sacroiliac joint

EXPERIMENTAL

The group which treats spine manual therapy of sacroiliac joint

Behavioral: spine manual therapy

Superficial heat therapy

ACTIVE COMPARATOR

Group treated with superficial heat therapy for 20 minutes

Device: Superficial heat therapy

Interventions

spine manual therapy BEHAVIORAL

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

spine manual therapy of sacroiliac joint

Superficial heat therapy DEVICE

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

Superficial heat therapy

Eligibility Criteria

• Age: 20 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

The wells neuropain clinic

Seoul, 05557, South Korea

Location

Study Officials

• Sungeon Park, Ph.D candidate

  The wells neuropain clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: April 30, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)