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Completed

NCT Number: NCT05752864

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.

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Key information

Conditions

Primary Dysmenorrhea

Age range

20 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The wells neuropain clinic

Seoul, 05557, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spine manual therapy

Behavioral

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

Superficial heat therapy

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual analog scale

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

    On a line consisting of 10 cm, 0 at either end represents 'no pain' and 10 represents 'worst pain'.

  2. Pressure pain threshold

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

    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.

  3. Menstrual distress questionnaire

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

    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.

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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