NCT07058480

Brief Summary

This prospective clinical trial evaluates the effects of a non-pharmacological intervention combining muscle energy technique (MET) and myofascial chain (MFC)-based pelvic stabilization training in women with primary dysmenorrhea (PD). The study aims to determine whether this combined approach can improve pelvic alignment, reduce menstrual pain, and enhance static balance. Participants are assigned to either an experimental group receiving MET + MFC-based training or a control group receiving conventional physiotherapy. Outcomes include radiographic pelvic parameters, pain intensity, and balance performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

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

Study Start

First participant enrolled

December 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 23, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

Pelvic Girdle DysfunctionMuscle Energy TechniquePelvic Stabilization TrainingPelvic Alignment

Outcome Measures

Primary Outcomes (1)

  • Change in menstrual pain intensity measured by Visual Analog Scale (VAS)

    The primary outcome was the change in pain intensity before and after intervention, assessed using the Visual Analog Scale (VAS,0-10). Participants rated their average menstrual pain during the most painful day of menstruation. A reduction in VAS score indicated improvement in dysmenorrhea symptoms.

    Baseline (pre-intervention), Week 4 (immediate post-intervention), and Week 12 (telephone follow-up to assess sustainability of treatment effects)

Secondary Outcomes (5)

  • Change in Pelvic Tilt (PT) Angle

    Baseline and Week 4 (end of intervention)

  • Change in Sacral Slope (SS) Angle

    Baseline and Week 4 (end of intervention)

  • Change in Pelvic Incidence (PI) Angle

    Baseline and Week 4 (end of intervention)

  • Change in Pelvic Asymmetry Score

    Baseline and Week 4 (end of intervention)

  • Change in Static Balance

    Baseline and Week 4 (end of intervention)

Study Arms (2)

Combined MET and MFC-Based Pelvic Stabilization

EXPERIMENTAL

Participants receive Muscle Energy Technique (MET) for iliac dysfunction and sacral torsion, plus myofascial chain-based pelvic stabilization training (curl-ups, planks, anti-rotation). 3 sessions/week, 50 minutes/session, for 4 weeks.

Behavioral: Combined MET and MFC-Based Pelvic Stabilization Training

Interferential current therapy (ICT) and Deep Friction Massage (DFM)

ACTIVE COMPARATOR

Participants receive medium- and low-frequency electrotherapy and deep friction massage targeting the lumbar (lower back), sacroiliac, and iliac crest regions. 3 sessions/week, 50 minutes/session, for 4 weeks.

Device: Interferential current therapy (ICT)Behavioral: Deep Friction Massage (DFM)

Interventions

This intervention consisted of a combination of Muscle Energy Technique (MET) for iliac and sacral dysfunctions (20 minutes per session) and myofascial chain-based pelvic stabilization training (including curl-ups, planks, and anti-rotation exercises; 30 minutes per session), targeting pelvic alignment and neuromuscular control. Sessions were conducted 3 times per week, 50 minutes per session, for 4 consecutive weeks.

Combined MET and MFC-Based Pelvic Stabilization

Interferential current therapy (ICT) was applied to the lumbar (lower back), sacroiliac, and iliac crest regions, 3 sessions per week, 20 minutes per session, for 4 weeks.

Interferential current therapy (ICT) and Deep Friction Massage (DFM)

Deep friction massage was administered to the lumbar, sacroiliac, and iliac crest regions for 30 minutes per session, 3 sessions per week, for 4 weeks.

Interferential current therapy (ICT) and Deep Friction Massage (DFM)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study specifically targets biologically female participants of reproductive age who experience moderate to severe primary dysmenorrhea, as defined by VAS ≥ 4.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged 18-45 years
  • Regular menstrual cycles
  • Clinically diagnosed with primary dysmenorrhea
  • Visual Analog Scale (VAS) score ≥ 4 during menstruation for at least six consecutive months
  • Radiographic evidence of pelvic tilt, sacral slope deviation, or frontal pelvic asymmetry

You may not qualify if:

  • Secondary dysmenorrhea or diagnosed gynecological pathologies (e.g., endometriosis, ovarian cysts)
  • Pregnancy or lactation
  • Current use of hormonal contraceptives or hormone therapy
  • Ongoing or recent physical therapy targeting the pelvis
  • History of pelvic or spinal surgery
  • Congenital or structural musculoskeletal disorders affecting the lumbopelvic region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen JianAn Hospital

Shenzhen, Guangdong, 518000, China

Location

Related Publications (4)

  • Gartenberg A, Nessim A, Cho W. Sacroiliac joint dysfunction: pathophysiology, diagnosis, and treatment. Eur Spine J. 2021 Oct;30(10):2936-2943. doi: 10.1007/s00586-021-06927-9. Epub 2021 Jul 16.

    PMID: 34272605BACKGROUND
  • Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104-13. doi: 10.1093/epirev/mxt009. Epub 2013 Nov 26.

    PMID: 24284871BACKGROUND
  • Wang J, He X, Zhu C, Ding H, Feng G, Yang X, Liu L, Song Y. The relationship between spino-pelvic alignment and primary dysmenorrhea. Front Surg. 2023 Feb 8;10:1125520. doi: 10.3389/fsurg.2023.1125520. eCollection 2023.

    PMID: 36843999BACKGROUND
  • Legaye J, Duval-Beaupere G, Hecquet J, Marty C. Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103. doi: 10.1007/s005860050038.

    PMID: 9629932BACKGROUND

Related Links

MeSH Terms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Shanjiao Luo, PhD

    Shenzhen JianAn Hospital / Sehan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This was an open-label study without any masked parties.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study adopted a prospective, two-arm parallel assignment design to compare the effects of MET combined with myofascial chain-based pelvic stabilization training versus conventional physiotherapy in women with primary dysmenorrhea.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate / Principal Investigator

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 10, 2025

Study Start

December 15, 2024

Primary Completion

January 31, 2025

Study Completion

March 31, 2025

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the primary and secondary outcome results reported in the manuscript will be shared. This includes demographic information, baseline measurements, and outcome data at each time point (e.g., VAS, pelvic alignment, and balance test results). No personally identifiable information will be disclosed.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD and supporting documentation will be available from 6 months after publication of the results in a peer-reviewed journal. The data will be accessible for a period of 2 years via request to the corresponding author (luoshanjiao@gmail.com).
Access Criteria
Qualified researchers with a methodologically sound proposal may request access to the de-identified individual participant data (IPD) and supporting documents. Requests should be directed to the corresponding author via email (luoshanjiao@gmail.com). Access will be granted on a case-by-case basis after approval by the study team.
More information

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