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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group(A) | Active Comparator | 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. |
|
| Control group(B) | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation(TENS) device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Red cell distribution width (RDW) | Peripheral venous blood samples were obtained from each patient. | change from baseline to after 12 weeks |
| Mean platelet volume(MPV) | Peripheral venous blood samples were obtained from each patient. | change from baseline to after 12 weeks |
| 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 |
| Arterial diameter | Diameter of lower limb arteries measured by doppler ultrasonography | change from baseline to after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy | Cairo | 12316 | Egypt |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |