Effect of Pilates Exercises and TENS Acupuncture in Primary Dysmenorrhea Among Female Students At KAU (KAU)

A Study on the Effectiveness of Pilates and TENS Acupuncture in Treating Primary Dysmenorrhea in Female Students At King Aboulaziz University (KAU)

This study was done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU).

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea Primary
• Intervention / Treatment: Device: Pilates exercises and TENS Acupuncture; Drug: ibuprofen 400 mg

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21589
    • King Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants suffering from primary dysmenorrhea.
• Their age ranged between 18-24 years
• Their BMI less than 30 kg/m2.

Exclusion Criteria:

• Gynecological disorders (secondary dysmenorrhea)
• Married females,
• Low back pain due to any other pathology
• Chronic diseases (diabetes, high blood pressure)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Pilates exercises and TENS Acupuncture	Device: Pilates exercises and TENS Acupuncture; All performed Pilates exercises for 24 session, 3 sessions per week for (2 consecutive menstrual cycle), each session lasted for 30 minutes in addition to application of TENS acupuncture therapy for 30 minutes, 3 sessions in the first 3 days for (2 consecutive menstrual cycle).
Experimental: Control group; Conservative treatment	Drug: ibuprofen 400 mg; All took capsules of ibuprofen(400-milligram) and instructed to take them once every eight hours for three days, one day before the start of their menstrual cycle and on the first two days of menstruation for (2 consecutive menstrual cycle).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue scale	Visual Analogue scale for assessing pain level, a score ranging from 0 to 100 mm.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal multidimensional scoring system of dysmenorrhea	Grade 0: The menstrual cycle causes no pain and has no effect on day-to-day activities.; Grade 1: Although uncomfortable menstruation never gets in the way of a woman's regular activities, and analgesics are rarely needed.; Grade 2 : daily activities are disrupted and analgesics have a poor effect .; Grade 3: Activity is obviously impeded, analgesics have a poor effect and symptoms such as headache, fatigue, nausea, vomiting, and diarrhea is present	2 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

Helpful Links

• article

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: FMRS-EC2024-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No