Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients

• ClinicalTrials.gov Identifier: NCT04830254
• Recruitment Status: Completed
• First Posted: April 5, 2021
• Last Update Posted: July 27, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Heba Ahmed Ali Abdeen, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Device: Transcutaneous Electrical Nerve Stimulation(TENS) device	Not Applicable

Detailed Description:

The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients
• Actual Study Start Date: January 20, 2021
• Actual Primary Completion Date: May 12, 2021
• Actual Study Completion Date: May 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: study group(A); 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; 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.; Other Name: TENS
Sham Comparator: Control group(B); 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; 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.; Other Name: TENS

Outcome Measures

Primary Outcome Measures :

1. Red cell distribution width (RDW) [ Time Frame: change from baseline to after 12 weeks ]
   Peripheral venous blood samples were obtained from each patient.
2. Mean platelet volume(MPV) [ Time Frame: change from baseline to after 12 weeks ]
   Peripheral venous blood samples were obtained from each patient.
3. Ankle peak systolic velocity (APSV) [ Time Frame: change from baseline to after 12 weeks ]
   is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography
4. Arterial diameter [ Time Frame: change from baseline to after 12 weeks ]
   Diameter of lower limb arteries measured by doppler ultrasonography

Secondary Outcome Measures :

1. Actual claudication distance [ Time Frame: change from baseline to after 12 weeks ]
   Claudication pain distance was measured after running on a treadmill constant walking speed of 2 mile/hour at 0% grade, with gradual increases in grade of 2.0% every 2 minutes.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Unilateral Leriche-Fontaine stage-II PAD
2. Both sexes
3. Aged 50 to 60 years
4. Outpatients
5. Clinically stable
6. Sedentary
7. Not participating in any physical activity last 3 months

Exclusion Criteria:

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

Contacts and Locations

Locations

Egypt

Faculty of Physical Therapy

Cairo, Egypt, 12316

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Heba Ahmed Ali Abdeen, Assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04830254
• Other Study ID Numbers: TENS21
• First Posted: April 5, 2021
• Last Update Posted: July 27, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases