Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

NCT ID: NCT06452615

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2024-10-01

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

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Extracorporeal shockwave

Intervention Type: 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

Control group

This group includes thirty female patients suffering from intercostobrachial neuralgia after a modified radical mastectomy. They will receive routine medical treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Abutaleb

Faculty of Physical therapy, Department Physical Therapy for Surgery and Burn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

from the National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Rehab Abotaleb

Role: primary

ehabkamelpop@gmail.com

00201023702370

Other Identifiers

No:P.T.REC/012/004573

Identifier Type: -

Identifier Source: org_study_id