Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: Extracorporeal shockwave

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • from the National Cancer Institute
    • Contact: Rehab Abotaleb; Phone Number: 00201023702370; Email: ehabkamelpop@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; They will receive Extracorporeal shockwave therapy (ESWT), two session per week for 8 weeks in addition to the routine medical treatment.	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
No Intervention: Control group; This group includes thirty female patients suffering from intercostobrachial neuralgia after a modified radical mastectomy. They will receive routine medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Mastectomy; Neuropathic Pain; Shock Wave Therapy; Intercostobrachial neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: No:P.T.REC/012/004573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No