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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Functional Exercise; Other: High Frequency Transcutaneous Electrical Nerve Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 38000
      • Ripah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Exercise; 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; 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.
Experimental: High Frequency Transcutaneous Electrical Nerve Stimulation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Randomized Control Trial; Primary Dysmenorrhea; Menstrual Pain; Transcutaneous Electrical Nerve Stimulation; Functional Exercise; High Frequency
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: REC-FSD-00250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No