NCT05461846

Brief Summary

Dysmenorrhea is a common problem in women of reproductive age. Primary dysmenorrhea is defined as recurrent, cramping pain occurring with menses in the absence of identifiable pelvic pathology .

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 11, 2022

Last Update Submit

July 14, 2022

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity.

    up to 2 months

Secondary Outcomes (2)

  • function

    up to 2 months

  • muscle amplitude in the form of normalized root mean square (RMS)

    up to 2 months

Study Arms (2)

Group (A)

EXPERIMENTAL

The integrated neuromuscular inhibition technique (INIT) is a manual deactivation trigger points technique and includes the application of ischemic pressure and stretch, the muscle energy technique and the Strain-counterstrain technique.

Other: integrated neuromuscular inhibition technique

Group (B)

NO INTERVENTION

control group

Interventions

integrated neuromuscular inhibition techniqueOTHER

is a manual deactivation trigger points technique and includes the application of ischemic pressure and stretch, the muscle energy technique and the Strain-counterstrain technique.

Group (A)

Eligibility Criteria

Age17 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Thirty adolescent females suffering from menstrual low back pain.
  • Their age will be ranged from 17 to 24 years.
  • Their body mass index will be ranged from 20 to 25 kg/m2.

You may not qualify if:

  • Personal and individual differences between the subjects.
  • Psychological and physical status of subjects which may affect the treatment and evaluation stage.
  • Environmental factors which may affect the subject's response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pt for basic science

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 18, 2022

Study Start

October 1, 2022

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

July 18, 2022

Record last verified: 2022-07