Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452615
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-17
Brief Title:
Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor chest wall significantly affects the patients 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
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 andor chest wall significantly affects the patients 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
Detailed Description:
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
1 The age range will be from 40 to 65 years
2 All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy
3 All patients suffering from moderate or severe pain of burning tingling numbness and electric nature persisting for 3-5 months following mastectomy in the anterior chest wall axilla and upper medial arm with altered sensitivity of the skin in the painful area
4 All patients had unilateral mild to moderate lymphedema circumference difference 4 cm
5 All patients will have completed their chemotherapy or radiotherapy treatment
6 All patients enrolled in the study will have their informed consent
Exclusive criteria
Patients will be excluded from the study if they meet any of the following criteria
1 Current metastases
2 Continuing radiotherapy or chemotherapy
3 History of allergy to coupling agent
4 Chronic inflammatory diseases and cellulitis
5 Venous thrombosis
6 Local infections
7 Patients with diabetes mellitus neuritis
8 Open skin lesions in the painful area
9 Other causes of arm pain brachial plexus neuropathy due to radiotherapy cervical radiculopathy peri-capsulitis of shoulder joint
Outcomes
ROM of the shoulder joint for flexion and extension
Level of pain
Inclusive criteria
The subject selection will be according to the following criteria
1 The age range will be from 40 to 65 years
2 All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy
3 All patients suffering from moderate or severe pain of burning tingling numbness and electric nature persisting for 3-5 months following mastectomy in the anterior chest wall axilla and upper medial arm with altered sensitivity of the skin in the painful area
4 All patients had unilateral mild to moderate lymphedema circumference difference 4 cm
5 All patients will have completed their chemotherapy or radiotherapy treatment
6 All patients enrolled in the study will have their informed consent
Exclusive criteria
Patients will be excluded from the study if they meet any of the following criteria
1 Current metastases
2 Continuing radiotherapy or chemotherapy
3 History of allergy to coupling agent
4 Chronic inflammatory diseases and cellulitis
5 Venous thrombosis
6 Local infections
7 Patients with diabetes mellitus neuritis
8 Open skin lesions in the painful area
9 Other causes of arm pain brachial plexus neuropathy due to radiotherapy cervical radiculopathy peri-capsulitis of shoulder joint
Outcomes
ROM of the shoulder joint for flexion and extension
Level of pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None