NCT07037329

Brief Summary

This study aimed to evaluate the comparative effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) on hemodynamic parameters in patients with hypertension. A total of 42 hypertensive patients were randomly divided into two equal groups: Group A received TENS, and Group B received EMS, over a period of four weeks. Pre- and post-treatment measurements of systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) were recorded. Results showed that both TENS and EMS produced significant improvements in all parameters within their respective groups.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • SF-36 Health Survey (Optional for Quality of Life)

    Measures general health status and quality of life 36 items grouped into 8 domains (e.g., physical functioning, general health) Each domain scored from 0 (worst) to 100 (best)

    6 Month

Study Arms (2)

Transcutaneous Electrical Nerve Stimulation (TENS)

EXPERIMENTAL
Diagnostic Test: Transcutaneous Electrical Nerve Stimulation (TENS)

Electrical Muscle Stimulation (EMS)

EXPERIMENTAL
Diagnostic Test: Electrical Muscle Stimulation (EMS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)DIAGNOSTIC_TEST

TENS is a non-invasive electrotherapy technique used to manage pain and modulate physiological responses such as blood pressure. In this study, patients in Group 1 received TENS therapy as the primary intervention.

Transcutaneous Electrical Nerve Stimulation (TENS)
Electrical Muscle Stimulation (EMS)DIAGNOSTIC_TEST

EMS is a form of electrotherapy that causes muscle contractions through electrical impulses delivered via surface electrodes. In this study, patients in Group 2 received EMS therapy to investigate its effect on hemodynamic parameters in individuals with hypertension.

Electrical Muscle Stimulation (EMS)

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (25-60 years) including both male and female
  • Patients clinically diagnosed with primary (essential) hypertension.
  • Blood pressure ranging from 140/90 mmHg to 160/100 mmHg (Stage 1 to early Stage 2 hypertension).
  • Participants who are not currently on intensive antihypertensive therapy or are on a stable dose of medication.
  • Willingness to participate voluntarily and provide written informed consent.
  • Patients who are not involved in any physical activity.
  • Participants who are overweight according to normal BMI.

You may not qualify if:

  • Secondary hypertension due to renal, endocrine, or other systemic causes. Individuals with pacemakers, implanted defibrillators, or other electronic medical devices.
  • Patients with severe cardiovascular conditions, such as recent myocardial infarction, heart failure, or arrhythmias.
  • History of seizure disorders or epilepsy. Cancer Patients
  • Presence of skin lesions, open wounds, or infections at the site of electrode placement.
  • Patients undergoing physiotherapy or electrical therapy elsewhere during the study period.
  • Individuals with known neurological or musculoskeletal disorders that could interfere with EMS or TENS effectiveness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasin Poly Clinic, Behria town Lahore

Lahore, Pakistan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

March 4, 2025

Primary Completion

June 1, 2025

Study Completion

September 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)