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

Peripheral Arterial Disease Clinical Trial

Official title:

Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830254
• Other study ID #: TENS21
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: May 20, 2021

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 20, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red cell distribution width (RDW)	Peripheral venous blood samples were obtained from each patient.	change from baseline to after 12 weeks
Primary	Mean platelet volume(MPV)	Peripheral venous blood samples were obtained from each patient.	change from baseline to after 12 weeks
Primary	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
Primary	Arterial diameter	Diameter of lower limb arteries measured by doppler ultrasonography	change from baseline to after 12 weeks
Secondary	Actual claudication distance	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.	change from baseline to after 12 weeks