Effect of Connective Tissue Massage on Premenstrual Syndrome

This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.

Study Overview

• Status: Not yet recruiting
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Drug: Multivitamins; Other: Connective tissue massage

Detailed Description

Premenstrual syndrome is a collection of emotional, physiological and behavioral symptoms that develop around the end of the luteal phase and fade away with or after mensturation.

The physiological effects of connective tissue massage (CTM) are both local and general. Local effects include release of histamine from mast cells which leads to a triple response, local swelling and arteriolar dilatation mediated by local axon reflexes. The increased blood flow to the region assists resolution of subacute or chronic inflammation and reduces pain by removing nocigenic chemicals from the tissues. The mechanical distortions produced by CTM strokes help to mobilize connective tissue and improve function.

Few studies have investigated the effect of the CTM on premenstrual syndrome in adolescent females. So this study will be conducted to add new information about the effect of connective tissue massage on premenstrual syndrome, which may help adolescent females suffering from this syndrome in decreasing their symptoms, thus adding new information to the field of physical therapy.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enas N Georgy, Master; Phone Number: +201222764419; Email: nosa.mannous@gmail.com
• Study Contact Backup: Name: Mohamed F Abo Eleinien, professor; Phone Number: +201001414404; Email: drmohamedfawzy61@icloud.com

Study Locations

• Egypt
  • Giza, Egypt
    • Enas Nabil Georgy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Virgin adolescent females diagnosed with premenstrual syndrome.
• Their age will be ranged from 17-25 years (3 years post puberty).
• Their body mass index (BMI) will be less than 30 kg/m2 .
• All are of regular menstrual cycles.
• All of them suffering from moderate and severe PMS.

Exclusion Criteria:

Participants will be excluded from this study if they have

• Any pathological finding in the pelvic cavity as polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
• Irregular menstruation.
• Any history of gynecological intervention.
• Open wounds, weak/broken bones or fractures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multivitamins group; This group will receive multivitamins capsule once daily, for 12 weeks.	Drug: Multivitamins; All participants will receive multivitamins (vitatron) capsule once daily, for 12 weeks.
Experimental: Connective tissue massage group; This group will receive multivitamins in addition to connective tissue massage on (Sacral, lumbar, last thoracic vertebrae-T12, and subcostal regions), 2 sessions/week, 20 minutes/ session for 12 weeks	Drug: Multivitamins; All participants will receive multivitamins (vitatron) capsule once daily, for 12 weeks.; Other: Connective tissue massage; Connective tissue massage will be applied on (Sacral, lumbar, last thoracic vertebrae-T12, and subcostal regions), 2 sessions/week for 20 minutes each session for 12 weeks. Treatment will begin 3 days before menstruation to the 4th day of menstruation for 3 successive menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Degrees of menstrual pain will be assessed using a VAS for all participants before and after treatment, which is a method of representing pain on a 10 cm linear scale. A score of zero means "No pain" and 10 means "a very high degree of pain".	3 months
Premenstrual syndrome severity	Severity of premenstrual symptoms will be assessed by using the Menstrual Distress Questionnaire (MDQ). Each participant will examine symptom categories (pain, concentration, water retention, behavior changes, negative effect, autonomic reaction, arousal and control) Participants are asked to report the symptoms experienced during their most recent menstrual period, using a rating scale. Responses ranged from (0) No experience of the symptom, (1) mild, (2) moderate, (3) severe and (4) very severe disabling symptoms. Overall scores are interpreted as follows: >50- mild, 50 to 70- moderate and >70 severe	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza B Kassab, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: P.T.REC/012/005312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No