NCT05158036

Brief Summary

The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Status
unknown

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

December 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

December 2, 2021

Last Update Submit

December 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Menstrual pain intensity will be evaluated with Visual Analogue Scale.

    change from baseline at an average of 2 weeks

Secondary Outcomes (3)

  • Pressure pain threshold

    change from baseline at an average of 2 weeks

  • Primary dysmenorrhea (PD)-related symptoms

    change from baseline at an average of 2 weeks

  • Functional and emotional effects

    change from baseline at an average of 2 weeks

Study Arms (2)

Classic massage group

ACTIVE COMPARATOR

Classical massage will be applied to the lumbal and abdominal region 5 days a week, from the estimated date of ovulation until the next menstrual bleeding begins. The application will take approximately 15 minutes. During the massage, the physiotherapist will apply stroking and kneading movements by using baby oil. During the treatment of the lumbal region, the patient will be in the prone position; during the treatment of the abdominal region, the patient will be in the supine position.

Other: Classic massage group

Connective tissue massage group

ACTIVE COMPARATOR

Connective tissue massage will be applied to the lumbosacral, lower thoracic, abdominal and anterior pelvic regions 5 days a week, from the estimated date of ovulation until the onset of the next menstrual bleeding. The application will take approximately 15 minutes. During the massage, the physiotherapist will bring the tip of the middle finger of the hand into contact with the patient's skin and apply traction to the skin. During the treatment of the lumbar region, the patient will be in the sitting position, during the treatment of the abdominal and anterior pelvic region, the patient will be in the supine position.

Other: Connective tissue masage

Interventions

Classic massage application will be given to the Classic massage group

Classic massage group

Connective tissue masage application will be given to the Connective tissue masage group

Connective tissue massage group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Women with a complaint of primary dysmenorrhea,
  • Volunteer women who have a regular menstrual cycle (28 ± 7 days)
  • Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months

You may not qualify if:

  • Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
  • Those who have given birth,
  • Those who have a pregnancy status,
  • Those who use intrauterine devices,
  • Those who have had pelvic surgery,
  • Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study,
  • Those with a pathological history and radiological findings showing secondary dysmenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly divided into two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

December 1, 2021

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

December 15, 2021

Record last verified: 2021-12