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

Cairo University (CU)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Transcutaneous Electrical Nerve Stimulation(TENS) device

Study type: Interventional

Funder types: Other

Identifiers

NCT04830254

TENS21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

study group(A)

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation(TENS) device

Control group(B)

Sham Comparator group

Description:

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

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation(TENS) device