Premenstrual SyndromeNCT06621680
Effect of Connective Tissue Massage on Premenstrual Syndrome
A study testing Multivitamins and Connective tissue massage in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Multivitamins and Connective tissue massage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Multivitamins, Connective tissue massage
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultivitaminsDrug
All participants will receive multivitamins (vitatron) capsule once daily, for 12 weeks.
Connective tissue massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multivitamins group | Active comparator | This group will receive multivitamins capsule once daily, for 12 weeks. Receives: Drug: Multivitamins |
| Connective tissue massage group | Experimental | 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 Receives: Drug: Multivitamins; Other: Connective tissue massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Nabil Georgy, Cairo University
- Investigators
- Azza B Kassab, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621680
- Sponsor's protocol ID
- P.T.REC/012/005312
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Connective Tissue Massage on Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06621680
- Acronym / sponsor ID
- P.T.REC/012/005312
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multivitamins group | Active comparator | Drug: MultivitaminsThis group will receive multivitamins capsule once daily, for 12 weeks. |
| Connective tissue massage group | Experimental | Drug: Multivitamins, Other: Connective tissue massageThis 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 |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultivitaminsAll participants will receive multivitamins (vitatron) capsule once daily, for 12 weeks. | Drug | Connective tissue massage group, Multivitamins group |
| Connective tissue massageConnective 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. | Other | Connective tissue massage group |
Primary outcome
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".
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azza B Kassab, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamins and Connective tissue massage in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enas N Georgy, Master (+201222764419, nosa.mannous@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.