NCT05439096

Brief Summary

The objective of this study is to assess the impacts of utilitarian exercise versus high frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students with primary dysmenorrhea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

June 27, 2022

Last Update Submit

March 7, 2023

Conditions

Primary Dysmenorrhea

Keywords

Functional ExerciseHigh FrequencyTranscutaneous Electrical Nerve StimulationPrimary DysmenorrheaMenstrual PainRandomized Control Trial

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    A Visual Analogue Scale is a measurement instrument, Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

    12th Week

Study Arms (2)

Functional Exercise

EXPERIMENTAL

* 2 stretching exercises * 1 yoga exercises * 2 core strengthening exercises * 2 pelvic area exercises * Kegel exercises * Warm up for 5 minutes the apply perform exercise 3 times a week for 8 weeks and 45 minutes duration at a time

Other: Functional Exercise

High Frequency Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

High frequency TENS by below mentioned parameters will be applied. * Pulse waveform = Biphasic waveform * Pulse recurrence = 50 to 120 Hz * Phase duration = 100 µsec * Current amplitudes = highest tolerable intensity with continuous adjustment * Skin arrangement = flawless skin region. * Type of electrodes = Self-adhesive * Size and location of electrodes = It will be adjusted specifically to each woman according to the typical area of her pain.

Other: High Frequency Transcutaneous Electrical Nerve Stimulation

Interventions

Functional ExerciseOTHER

Among Functional Exercises, cobra position is most effective in reducing pelvic pain while others are cat and fish position.Kegel exercises along with other strengthening activities for pelvic floor muscles have been accounted for in writing to favorably affect primary dysmenorrheal.

Functional Exercise
High Frequency Transcutaneous Electrical Nerve StimulationOTHER

Transcutaneous electrical nerve stimulation, best treat primary dysmenorrhea. Transcutaneous Electrical Nerve Stimulation is proposed as an incredible spasm decrease, lessening torment, decline of analgesics and improving personal satisfaction in primary dysmenorrhea patients.

High Frequency Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales Experiencing Primary Dysmenorrhea
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed instance of primary dysmenorrhea
  • Age somewhere in the range of 18 and 30 years,
  • A history of lower stomach torment for in excess of 6 periods.
  • Moderate or serious torment, with a numeric rating scale (NRS) score ≥5 out of 10.
  • No elective treatment including TENS inside multi month before enlistment in the investigation; and
  • Provision of educated agree preceding enlistment in the examination.

You may not qualify if:

  • Pregnant or Breastfeeding,
  • History of medical procedure of the lower midsection,
  • Heart sickness,
  • Cancer,
  • Severe mental problems.
  • Those who couldn't utilize TENS, for instance, in view of a lasting pacemaker or skin infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

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

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

March 1, 2021

Primary Completion

July 20, 2022

Study Completion

July 28, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)