Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

Neuropathic Pain Clinical Trial

Official title:

Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452615
• Other study ID #: No:P.T.REC/012/004573
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

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).

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Extracorporeal shockwave
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).