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Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Functional Exercise

High Frequency Transcutaneous Electrical Nerve Stimulation

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Functional Exercise, High Frequency, Transcutaneous Electrical Nerve Stimulation, Primary Dysmenorrhea, Menstrual Pain, Randomized Control Trial

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Ripah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Functional Exercise

High Frequency Transcutaneous Electrical Nerve Stimulation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Full Information

NCT ID

NCT05439096

First Posted

June 27, 2022

Last Updated

March 7, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05439096

Brief Title

Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea

Official Title

Comparative Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Pain and Sleep Quality in Students With Primary Dysmenorrhea

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

July 20, 2022 (Actual)

Study Completion Date

July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

A Randomized Control Trial study will be directed at Riphah International University Faisalabad after synopsis approval. The Purposive examining method will be utilized to enlist the patients. Patients will be enrolled according to the pre-characterized criteria. Sample size for this examination is 40 females (18 yrs - 30 yrs) as per determination measures. The patients of one group will recieve exercise therapy and patients of other group will recieve high frequency Transcutaneous Electrical Nerve Stimulation. The patient's result will be assessed following a month of treatment . Informed consent will be taken from each patient. Data entry and analysis will be done with Statistical Package of Social Sciences version 20.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea

Keywords

Functional Exercise, High Frequency, Transcutaneous Electrical Nerve Stimulation, Primary Dysmenorrhea, Menstrual Pain, Randomized Control Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Functional Exercise

Arm Type

Experimental

Arm Description

Arm Title

High Frequency Transcutaneous Electrical Nerve Stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Functional Exercise

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

High Frequency Transcutaneous Electrical Nerve Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual Analogue Scale

Description

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."

Time Frame

12th Week

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Females Experiencing Primary Dysmenorrhea

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Kashif

Organizational Affiliation

Riphah International University

Official's Role

Study Chair

Facility Information:

Facility Name

Ripah International University

City

Faisalabad

State/Province

Punjab

ZIP/Postal Code

38000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea

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