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

NCT ID: NCT04830254

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2021-05-20

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.

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation(TENS) device

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation(TENS) device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TENS

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Ali Abdeen

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

TENS21

Identifier Type: -

Identifier Source: org_study_id