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NCT Number: NCT06621680

Effect of Connective Tissue Massage on Premenstrual Syndrome

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

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Key information

Age range

17 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Enas Nabil Georgy

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multivitamins

Drug

All participants will receive multivitamins (vitatron) capsule once daily, for 12 weeks.

Connective Tissue Massage

Other

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.

Primary outcomes

  1. Pain intensity

    Time frame: 3 months

    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".

  2. Premenstrual syndrome severity

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Enas N Georgy, Master

CONTACT

[email protected]

+201222764419

Mohamed F Abo Eleinien, professor

CONTACT

[email protected]

+201001414404

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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