NCT04830254

Brief Summary

Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.

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 Jan 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

March 31, 2021

Last Update Submit

July 26, 2021

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

  • Red cell distribution width (RDW)

    Peripheral venous blood samples were obtained from each patient.

    change from baseline to after 12 weeks

  • Mean platelet volume(MPV)

    Peripheral venous blood samples were obtained from each patient.

    change from baseline to after 12 weeks

  • Ankle peak systolic velocity (APSV)

    is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography

    change from baseline to after 12 weeks

  • Arterial diameter

    Diameter of lower limb arteries measured by doppler ultrasonography

    change from baseline to after 12 weeks

Secondary Outcomes (1)

  • Actual claudication distance

    change from baseline to after 12 weeks

Study Arms (2)

study group(A)

ACTIVE COMPARATOR

Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks.

Device: Transcutaneous Electrical Nerve Stimulation(TENS) device

Control group(B)

SHAM COMPARATOR

The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation

Device: Transcutaneous Electrical Nerve Stimulation(TENS) device

Interventions

Transcutaneous Electrical Nerve Stimulation(TENS) deviceDEVICE

The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.

Also known as: TENS
Control group(B)study group(A)

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral Leriche-Fontaine stage-II PAD
  • Both sexes
  • Aged 50 to 60 years
  • Outpatients
  • Clinically stable
  • Sedentary
  • Not participating in any physical activity last 3 months

You may not qualify if:

  • Walking disorders related to orthopedic or neuromuscular disease
  • Renal insufficiency requiring dialysis (Renal diseases)
  • Known and documented myopathy
  • Progressive cancer
  • Associated progressive disease causing a deterioration in general health
  • Participation in another research protocol
  • Skin disorder making it impossible to use TENS
  • Absolute contraindication to physical activity
  • Presence of a pacemaker/defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

January 20, 2021

Primary Completion

May 12, 2021

Study Completion

May 20, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)