NCT07063472

Brief Summary

Premenstrual Syndrome (PMS) has a wide variety of signs and symptoms, including physical, psychological, and behavioral symptoms severe enough to disrupt daily activities. Objective: The study aimed to compare the effectiveness of a Tele-Pilates intervention and Kinesio Taping in managing symptoms of premenstrual syndrome (PMS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 25, 2025

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Premenstrual Syndrome Questionnaire (PMSQ)

    The Premenstrual Syndrome Questionnaire (PMSQ) is a validated and reliable evaluation method for assessing PMS symptoms. It comprises five subscales: PMS-anxiety (PMS-A), PMS-depression (PMS-D), PMS-craving (PMS-C), PMS-hyperhydration (PMS-H), and a subscale for other associated symptoms. Additionally, the assessment includes two symptoms frequently reported during the initial two days of menstruation-cramps and backache. The PMS-A subscale addresses affective symptoms such as anxiety, irritability, mood swings, and nervous tension. PMS-D encompasses depressive symptoms, including depression, crying, forgetfulness, confusion, and insomnia. PMS-C evaluates somatic and behavioral symptoms such as increased appetite, headaches, fatigue, dizziness or fainting, and palpitations. PMS-H focuses on fluid retention, weight gain, breast tenderness, and abdominal bloating. The Other symptoms subscale covers a ra. The total PMSQ score ranges from 1 to 84, with higher scores indicating more severe

    The participants answered the questionnaire items before the study course and after 8 weeks.

Study Arms (3)

Tele-Pilates

EXPERIMENTAL

The TP program included warm-up, main session, and cool-down phases. The session started with warm-up exercises in the form of breathing, spinal twist, cat stretch, arm circles, and abdominal stretching. Each exercise was performed for five repetitions, with each repetition held for 10-15 seconds and followed by a 5-second rest period. The warm-up phase lasted a total of 10 minutes. Tele-Pilates was supervised by a Pilates professional trainer. Participants engaged in mat-based Pilates exercises. These exercises included roll-up, bug leg, crock leg lying, prone single leg kick, bug roll, knee/lumbar roll, and prone attitude rotation. There was a 20-second rest in between the exercises. Each exercise was 3¬-5 reps, 10-¬15 sec hold, 5 secs rest. . The Pilates exercise protocol lasted for 8 weeks, with two sessions per week (totaling 16 sessions), each lasting 30 minutes. The session ended with 10-minute cool-down that involved relaxation exercises and stretching.

Behavioral: Tele- pilates

Kinesio Tape

OTHER

Kinesio taping application for the KT group The participant sat upright in a chair, and a piece of kinesiology tape (5 × 5 cm, 3NS, Korea) was used to measure the distance from just above the anus to the upper border of the pelvis. This measured length was then divided by eight, and the tape was cut accordingly. One end of the tape was anchored on the ulnar bone just above the inguinal region. With 25% stretch, the tape was applied diagonally upward and outward, following the contour of the iliac crest over the ilium. The second end was secured to overlap the base of the initial tape. A second strip was applied in a similar manner in the opposite direction over the ilium. KT was applied for over eight weeks, with the tape changed every three days

Device: Kinesio taping application for the KT group

Control group

NO INTERVENTION

Interventions

Tele- pilatesBEHAVIORAL

Tele-Pilates for (TP) group The TP program included warm-up, main session, and cool-down phases. The session started with warm-up exercises in the form of breathing, spinal twist, cat stretch, arm circles, and abdominal stretching. Each exercise was performed for five repetitions, with each repetition held for 10-15 seconds and followed by a 5-second rest period. The warm-up phase lasted a total of 10 minutes. Tele-Pilates was supervised by a Pilates professional trainer. Participants engaged in mat-based Pilates exercises. These exercises included roll-up, bug leg, crock leg lying, prone single leg kick, bug roll, knee/lumbar roll, and prone attitude rotation.The session ended with 10-minute cool-down that involved relaxation exercises and stretching.

Tele-Pilates

Kinesio taping application for the KT group The participant sat upright in a chair, and a piece of kinesiology tape (5 × 5 cm, 3NS, Korea) was used to measure the distance from just above the anus to the upper border of the pelvis. This measured length was then divided by eight, and the tape was cut accordingly. One end of the tape was anchored on the ulnar bone just above the inguinal region. With 25% stretch, the tape was applied diagonally upward and outward, following the contour of the iliac crest over the ilium. The second end was secured to overlap the base of the initial tape. A second strip was applied in a similar manner in the opposite direction over the ilium. KT was applied for over eight weeks, with the tape changed every three days

Kinesio Tape

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFor a study on Premenstrual Syndrome (PMS), eligibility should typically be limited to participants assigned female at birth who currently menstruate
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible participants had a regular menstrual cycle lasting 28 to 31 days for at least the previous three months, a visual analog scale (VAS) pain score of 4.0 or higher, and a normal body mass index (BMI)

You may not qualify if:

  • Pelvic inflammatory disease or endometriosis
  • The use of analgesics or oral contraceptives during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Outpatient Clinics, Alsalam University

Cairo, Tanta, 11611, Egypt

Location

Related Links

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual SyndromeMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Doaa Osthman O Doaa Osman, Assistant Professor

    Cairo University

    STUDY DIRECTOR
  • Asmaa M. Elbandrawy, Professor

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physical Therapy for Women's Health

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 14, 2025

Study Start

January 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

July 14, 2025

Record last verified: 2025-06

Locations