NCT07314021

Brief Summary

72 women diagnosed with primary dysmenorrhea were included in the study and divided into four groups. the first group received treatment with a mobilization approach, the second group received motor imagery-focused exercises and the third group, as a electrotherapy group and fourth received no treatment was applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

December 4, 2025

Last Update Submit

June 28, 2026

Conditions

Keywords

mobilizationprimary dysmenorrheaexercise

Outcome Measures

Primary Outcomes (1)

  • Short-Form McGill Pain Questionnaire Total Pain Score

    Pain intensity was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ total pain score, calculated as the sum of sensory and affective pain descriptor scores, was defined as the primary outcome. Higher scores indicate greater pain severity.

    12 weeks

Secondary Outcomes (4)

  • Menstrual Attitude Questionnaire

    12 weeks

  • Functional and Emotional Dysmenorrhea Scale

    12 weeks

  • Menstrual Symptom Questionnaire

    12 weeks

  • The Menstrual Distress Questionnaire

    12 weeks

Study Arms (4)

FEMOB

ACTIVE COMPARATOR

Structured multimodal mobilization (FEMOB) is a manual therapy-based mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.

Other: FEMOB

MOPEXE

ACTIVE COMPARATOR

Participants in the MOPEXE arm receive a 60-minute Pilates-based motor imagery-focused pelvic floor exercise program twice weekly for 12 weeks. Each session consists of 5 minutes of meditation, 10 minutes of progressive relaxation training using the Bernstein-Borkovec method, 5 minutes of diaphragmatic and pursed-lip breathing exercises, 35 minutes of motor imagery-focused pelvic floor exercises, and a final 5 minutes of meditation. Outcomes are assessed at baseline and after completion of the 12-week intervention period.

Other: MOPEXE

Conventional treatment group

OTHER

The conventional treatment arm receives TENS and hot pack application. TENS is administered with the Chattanooga Intelect Advanced Combo system at 100 Hz and 200 µs for 30 minutes using two channels and four electrodes placed over the lumbar and suprapubic regions. Hot pack application is applied to the lumbar and suprapubic regions for a total of 20 minutes.

Other: Conventional Treatment group

CONTROL

NO INTERVENTION

Participants in the control group received no active treatment, exercise program, or physiotherapy intervention during the study period. They were instructed to continue their routine daily activities and not to initiate any new pharmacological or non-pharmacological treatment for dysmenorrhea symptoms during the study.

Interventions

FEMOBOTHER

FEMOB is a structured multimodal mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.

FEMOB
MOPEXEOTHER

MOPEXE is a Pilates-based motor imagery-focused pelvic floor exercise program. Each 60-minute session consists of 5 minutes of meditation, 10 minutes of progressive relaxation training using the Bernstein-Borkovec method, 5 minutes of diaphragmatic and pursed-lip breathing exercises, 35 minutes of motor imagery-focused pelvic floor exercises, and a final 5 minutes of meditation. Sessions are delivered twice weekly for 12 weeks.

MOPEXE

The conventional treatment arm receives TENS and hot pack application. TENS is administered with the Chattanooga Intelect Advanced Combo system at 100 Hz and 200 µs for 30 minutes using two channels and four electrodes placed over the lumbar and suprapubic regions. Hot pack application is applied to the lumbar and suprapubic regions for 20 minutes.

Conventional treatment group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-30 years
  • Clinically confirmed primary dysmenorrhea
  • Regular menstrual cycles during the previous six months
  • Menstrual pain intensity of ≥4 cm on the Visual Analog Scale (VAS)
  • Voluntary agreement to participate in the study

You may not qualify if:

  • Secondary dysmenorrhea or gynecological pathology such as endometriosis, uterine fibroids, or pelvic inflammatory disease
  • Pregnancy
  • Pelvic physiotherapy within the previous six months
  • Neurological, rheumatological, or serious systemic disease
  • Communication difficulties preventing participation or questionnaire completion
  • Regular use of oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.

    PMID: 32379680BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 2, 2026

Study Start

December 5, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations