Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

Not Applicable

Recruiting

• Conditions: Neuropathic Pain
• Interventions: Device: Extracorporeal shockwave

• Registration Number: NCT06452615
• Lead Sponsor: Cairo University

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, 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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Study Start: 2024-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. 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, 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 to the study will have their informed consent.

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Exclusion 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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Extracorporeal shockwave	They will receive Extracorporeal shockwave therapy (ESWT), two session per week for 8 weeks in addition to the routine medical treatment.

Primary Outcome Measures

Name	Time	Method
Range of Motion	Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).	Shoulder Flexion and Abduction will be assessed from supine position
Neuropathic Pain	at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).	The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients.

Trial Locations

Locations (1)

from the National Cancer Institute; 🇪🇬 Cairo, Egypt