A New Treatment for Primary Dysmenorrhea

NCT ID: NCT07213336

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-05-01

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.

Conditions

Primary Dysmenorrhea (PD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. group

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

2.group

Stretching exercise group

Group Type: EXPERIMENTAL

Exercise, massage

Intervention Type: OTHER

trigger point massage and stretching exercise

3.group

trigger point massage and stretching exercise group

Group Type: EXPERIMENTAL

Exercise, massage

Intervention Type: OTHER

trigger point massage and stretching exercise

Interventions

Exercise, massage

trigger point massage and stretching exercise

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Halic University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep İrem Kar

specialist physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

melek g yavuzer

Role: STUDY_DIRECTOR

Locations

Halic University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HalicU-FTR-ZİK-01

Identifier Type: -

Identifier Source: org_study_id