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PURPOSE: The main objective of the study is:
to evaluate the therapeutic effect of ESWT on intercostobrachial neuralgia post-mastectomy.
BACKGROUND:
Intercostobrachial neuralgia post-mastectomy is thought to develop from surgical damage to the intercostobrachial nerve, this nerve is injured in 80-100 % of mastectomy patients who undergo axillary lymph nodes dissection.
Pain that is localized in the axilla, medial upper arm, breast, and/or chest wall significantly affects the patient's mood, everyday activities, and social functioning, causing a heavy economic burden on healthcare systems. If poorly treated, patients may develop an immobilized arm, which can lead to severe lymphedema, frozen shoulder syndrome, and complex regional pain syndrome.
HYPOTHESES:
It will be hypothesized that:
Shock wave therapy has no effect in improving intercostobrachial neuralgia post-mastectomy.
Sixty female patients aged 40 and 65 years, suffering from intercostobrachial neuralgia after modified radical mastectomy will be selected from the National Cancer Institute, Cairo, Egypt. They will be randomly assigned into two equal groups, thirty patients each (study group and control group). The intervention in the study group will be conducted for 8 weeks.
Inclusive criteria :
The subject selection will be according to the following criteria:
Exclusive criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | They will receive Extracorporeal shockwave therapy (ESWT), two session per week for 8 weeks in addition to the routine medical treatment. |
|
| Control group | No Intervention | This group includes thirty female patients suffering from intercostobrachial neuralgia after a modified radical mastectomy. They will receive routine medical treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shockwave | Device | The patients will receive 3000 to 6000 pulses every session by a radius of 15 mm probe (R15) at a frequency of 10 Hz, with energy gradually increasing from 1.4 to 1.5 bar |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain | The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients. | at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment). |
| Range of Motion | Shoulder Flexion and Abduction will be assessed from supine position | Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| from the National Cancer Institute | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |