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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04830254
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 10.1

Study Details

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	N/A

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
• 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: Jan 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 Names: 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 Names: TENS

Outcome Measures

Primary Outcome Measures

1. Red cell distribution width (RDW) [change from baseline to after 12 weeks]

   Peripheral venous blood samples were obtained from each patient.

2. Mean platelet volume(MPV) [change from baseline to after 12 weeks]

   Peripheral venous blood samples were obtained from each patient.

3. Ankle peak systolic velocity (APSV) [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 [change from baseline to after 12 weeks]

   Diameter of lower limb arteries measured by doppler ultrasonography

Secondary Outcome Measures

1. Actual claudication distance [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy	Cairo		Egypt	12316

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heba Ahmed Ali Abdeen, Assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04830254
• Other Study ID Numbers: TENS21
• First Posted: Apr 5, 2021
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Jul 27, 2021