A New Treatment for Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea (PD)

• Registration Number: NCT07213336
• Lead Sponsor: Halic University

Brief Summary

Primary dysmenorrhea (PD) is a chronic health condition that affects primarily young women and interferes with daily activities, causes loss of work productivity, and reduces quality of life. In this controlled study, the effects of trigger point massage and stretching exercises applied to patients diagnosed with primary dysmenorrhea on pain severity (Visual Analog Scale), menstrual symptoms (Menstruation Symptom Scale) and quality of life (SF-36) were investigated. Forty-five women who were followed up with the diagnosis of Primary Dysmenorrhea in the Gynecology and Obstetrics Clinic of a local Hospital. Participants were randomly assigned to exercise, exercise+trigger point, and control groups using a computer-generated randomization list. The "Visual Analog Scale" was used to evaluate the severity of menstrual pain, "Menstruation Symptom Scale" was used to evaluate the severity of menstrual symptoms, and "SF-36" was used to evaluate the quality of life.

Detailed Description

This controlled experimental study included 45 volunteers diagnosed with primary dysmenorrhea by a gynecologist. Participants were randomly assigned to three groups using the "Research Randomizer" web program. The control group (n=14) received no intervention. The stretching exercise group (n=15) received only stretching exercises; the stretching and trigger point group (n=15) received stretching exercises plus trigger point massage of the quadratus lumborum, rectus abdominus, iliopsoas, and hip adductor muscles, all performed by the same trained physiotherapist.

Study Inclusion Criteria:

* Being a woman between the ages of 18 and 30,

* Having a diagnosis of primary dysmenorrhea,

* Being a nulliparous,

* Having a regular menstrual cycle (28 ± 7 days). Exclusion Criteria

* Having rheumatic, gastrointestinal, psychiatric, surgical, or other chronic pain syndromes;

* Being on any anti-inflammatory, analgesic, or non-convertible progestin pill (OCP) Participants in the control group were not included in the treatment program administered to the other participants for 8 weeks, but continued the NSAID medication prescribed by the doctor who diagnosed dysmenorrhea.

Participants in the stretching group underwent a 45-minute exercise program twice a week, accompanied by a physiotherapist, for 8 weeks. Participants in the stretching exercises and trigger point massage group underwent a 45-minute exercise program twice a week, accompanied by a physiotherapist, for 8 weeks.

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-05-01
• Study First Submitted: 2025-09-17
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Being a woman between the ages of 18 and 30
• Having a diagnosis of primary dysmenorrhea
• Not having given birth
• Having a regular menstrual cycle (28 ± 7 days)

Exclusion Criteria

• Having been diagnosed with rheumatic, gastrointestinal, psychiatric, neurological diseases, or other chronic pain syndromes
• Being on any anti-inflammatory, analgesic, or estrogen/progestin pill (OCP) treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SF-36	The 1st and 3rd Most Painful Days of the Menstrual Cycle	SF-36: This questionnaire has 8 subscales, totaling 36 questions: 10 items on "physical function," 7 items on "role limitations due to physical (4 items) and emotional problems (3 items), 2 items on "pain," 4 items on "vitality," 2 items on "social function," 5 items on "mental health," and 5 items on "general health.
Visual Analog Scale	The 1st and 3rd Most Painful Days of the Menstrual Cycle	Visual Analog Scale: The visual analog scale (VAS) is the most commonly used tool for assessing pain intensity. It is easy to use, provides reproducible results, and can be applied to a variety of practice settings.
Personal Information Form	The 1st and 3rd Most Painful Days of the Menstrual Cycle	Personal Information Form: This form includes personal information.
menstrual symptom scale	The 1st and 3rd Most Painful Days of the Menstrual Cycle	It consists of a 5-point Likert-type scale with a total of 24 items. Individuals are asked to rate their menstruation-related symptoms between 1 (never) and 5 (always). The MBI score is calculated by averaging the total scores of the scale items. A higher mean score indicates an increased severity of menstrual symptoms.

Trial Locations

Locations (1)

Halic University; Istanbul, Turkey (Türkiye)