Primary Dysmenorrhea (PD)METPD-25NCT07058480
Muscle Energy Technique and Myofascial Chain Training for Menstrual Pain in Primary Dysmenorrhea (METPD-25)
A study testing Combined MET and MFC-Based Pelvic Stabilization Training, Interferential current therapy (ICT) and Deep Friction Massage (DFM) in people with Primary Dysmenorrhea (PD), run by Shanjiao Luo at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Combined MET and MFC-Based Pelvic Stabilization Training, Interferential current therapy (ICT) and Deep Friction Massage (DFM)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 31 Mar 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Muscle Energy Technique and Myofascial Chain Stabilization Reduces Menstrual Pain and Improves Pelvic Alignment in Women With Primary Dysmenorrhea: A Prospective Study
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.
Read the detailed description
Primary dysmenorrhea (PD) is a common gynecological condition characterized by cyclic lower abdominal pain without an identifiable organic cause. Biomechanical factors such as pelvic misalignment and myofascial imbalance are increasingly recognized as contributing to the persistence and severity of PD.
This prospective non-randomized controlled trial investigates whether a combined intervention of muscle energy technique (MET) and myofascial chain (MFC)-based pelvic stabilization training can improve pelvic structure and reduce clinical symptoms in women with PD. Participants are women aged 18-45 years with moderate-to-severe PD and radiographic evidence of pelvic misalignment. They are assigned to one of two groups:
Experimental group: MET plus MFC-based core stabilization exercises. Control group: Interferential current therapy and deep friction massage. Interventions are administered three times per week for four weeks. The primary outcomes include changes in pelvic sagittal parameters (pelvic tilt, sacral slope, pelvic incidence), pelvic symmetry, menstrual pain (measured by VAS), and static balance (eyes-closed single-leg stance). Assessments are conducted at baseline, 4 weeks, and 12 weeks post-intervention.
The study aims to explore whether biomechanical correction of pelvic alignment contributes to pain modulation and functional improvement in women with PD, providing a basis for non-pharmacological rehabilitation strategies.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Combined MET and MFC-Based Pelvic Stabilization Training, Interferential current therapy (ICT), Deep Friction Massage (DFM)
- Keywords
- Pelvic Girdle Dysfunction, Muscle Energy Technique, Pelvic Stabilization Training, Pelvic Alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined MET and MFC-Based Pelvic Stabilization TrainingBehavioural
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.
Interferential current therapy (ICT)Device
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.
Deep Friction Massage (DFM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Interferential current therapy (ICT); Behavioral: Deep Friction Massage (DFM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in PT (degrees) from baseline to Week 4, assessed by standardized lateral pelvic radiograph.
Measured: Baseline and Week 4 (end of intervention)
Change in Sacral Slope (SS) Angle
Change in SS (degrees) from baseline to Week 4, assessed by standardized lateral pelvic radiograph.
Measured: Baseline and Week 4 (end of intervention)
Change in Pelvic Incidence (PI) Angle
Change in PI (degrees) from baseline to Week 4, assessed by standardized lateral pelvic radiograph.
Measured: Baseline and Week 4 (end of intervention)
Change in Pelvic Asymmetry Score
Change in pelvic asymmetry assessed by frontal pelvic X-rays from baseline to Week 4. Pelvic asymmetry is determined by a composite score based on iliac crest height discrepancy, anterior/posterior innominate rotation, adduction/abduction shift, and sacral torsion.
Measured: Baseline and Week 4 (end of intervention)
Change in Static Balance
Change in single-leg stance time (seconds, eyes closed) from baseline to Week 4.
Measured: Baseline and Week 4 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Dec 2024
- Primary completion31 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanjiao Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shanjiao Luo, Shenzhen Jianan Hospital
- Investigators
- Shanjiao Luo, PhD, Principal investigator, Shenzhen JianAn Hospital / Sehan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058480
- Sponsor's protocol ID
- JAH-METPD-2025-01
- Acronym
- METPD-25
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34272605Ju 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.
PubMed 24284871Wang 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.
PubMed 36843999Legaye 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.
PubMed 9629932
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Muscle Energy Technique and Myofascial Chain Stabilization Reduces Menstrual Pain and Improves Pelvic Alignment in Women With Primary Dysmenorrhea: A Prospective Study
- ClinicalTrials.gov ID
- NCT07058480
- Acronym / sponsor ID
- METPD-25 / JAH-METPD-2025-01
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Pelvic Girdle Dysfunction, Muscle Energy Technique, Pelvic Stabilization Training, Pelvic Alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanjiao LuoUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Jul 2025 (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 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.
Detailed description
Primary dysmenorrhea (PD) is a common gynecological condition characterized by cyclic lower abdominal pain without an identifiable organic cause. Biomechanical factors such as pelvic misalignment and myofascial imbalance are increasingly recognized as contributing to the persistence and severity of PD.
This prospective non-randomized controlled trial investigates whether a combined intervention of muscle energy technique (MET) and myofascial chain (MFC)-based pelvic stabilization training can improve pelvic structure and reduce clinical symptoms in women with PD. Participants are women aged 18-45 years with moderate-to-severe PD and radiographic evidence of pelvic misalignment. They are assigned to one of two groups:
Experimental group: MET plus MFC-based core stabilization exercises. Control group: Interferential current therapy and deep friction massage. Interventions are administered three times per week for four weeks. The primary outcomes include changes in pelvic sagittal parameters (pelvic tilt, sacral slope, pelvic incidence), pelvic symmetry, menstrual pain (measured by VAS), and static balance (eyes-closed single-leg stance). Assessments are conducted at baseline, 4 weeks, and 12 weeks post-intervention.
The study aims to explore whether biomechanical correction of pelvic alignment contributes to pain modulation and functional improvement in women with PD, providing a basis for non-pharmacological rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined MET and MFC-Based Pelvic Stabilization | Experimental | Behavioral: Combined MET and MFC-Based Pelvic Stabilization TrainingParticipants 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. |
| Interferential current therapy (ICT) and Deep Friction Massage (DFM) | Active comparator | Device: Interferential current therapy (ICT), Behavioral: Deep Friction Massage (DFM)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Combined MET and MFC-Based Pelvic Stabilization TrainingThis 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. | Behavioural | Combined MET and MFC-Based Pelvic Stabilization |
| Interferential current therapy (ICT)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. | Device | Interferential current therapy (ICT) and Deep Friction Massage (DFM) |
| 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. | Behavioural | Interferential current therapy (ICT) and Deep Friction Massage (DFM) |
Primary outcome
Change in menstrual pain intensity measured by Visual Analog Scale (VAS)
Time frame: Baseline (pre-intervention), Week 4 (immediate post-intervention), and Week 12 (telephone follow-up to assess sustainability of treatment effects)
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.
5 secondary outcomes
Change in Pelvic Tilt (PT) Angle
Time frame: Baseline and Week 4 (end of intervention)
Change in Sacral Slope (SS) Angle
Time frame: Baseline and Week 4 (end of intervention)
Change in Pelvic Incidence (PI) Angle
Time frame: Baseline and Week 4 (end of intervention)
Change in Pelvic Asymmetry Score
Time frame: Baseline and Week 4 (end of intervention)
Change in Static Balance
Time frame: Baseline and Week 4 (end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 34272605Gartenberg 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.
- Background: PubMed 24284871Ju 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.
- Background: PubMed 36843999Wang 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.
- Background: PubMed 9629932Legaye 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.
- Shenzhen JianAn Hospital official website, the clinical trial site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Shanjiao Luo, PhD principal investigator
Shenzhen JianAn Hospital / Sehan 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 Combined MET and MFC-Based Pelvic Stabilization Training, Interferential current therapy (ICT) and Deep Friction Massage (DFM) in people with Primary Dysmenorrhea (PD), run by Shanjiao Luo at 1 site in China.
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 6 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: finished, as of the sponsor's last update on 10 Jul 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menstrual pain intensity measured by Visual Analog Scale (VAS) (time frame: Baseline (pre-intervention), Week 4 (immediate post-intervention), and Week 12 (telephone follow-up to assess sustainability of treatment effects)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07058480, which also lists 4 linked publications.
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 10 Jul 2025.