Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

NCT06452615 | Recruiting

• 1 other identifier: No:P.T.REC/012/004573
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Shock Wave Therapy; Mastectomy; Intercostobrachial neuralgia; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

Study group

EXPERIMENTAL

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

Device: Extracorporeal shockwave

Control group

NO INTERVENTION

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

Interventions

Extracorporeal shockwave 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

Study group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range will be from 40 to 65 years.
• All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy.
• 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.
• All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm).
• All patients will have completed their chemotherapy or radiotherapy treatment.
• All patients enrolled to the study will have their informed consent.

You may not qualify if:

• Current metastases.
• Continuing radiotherapy or chemotherapy.
• History of allergy to coupling agent.
• Chronic inflammatory diseases and cellulitis.
• Venous thrombosis.
• Local infections.
• Patients with diabetes mellitus (neuritis).
• Open skin lesions in the painful area.
• Other causes of arm pain (brachial plexus neuropathy due to radiotherapy, cervical radiculopathy, peri-capsulitis of shoulder joint).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

from the National Cancer Institute

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Physical therapy, Department Physical Therapy for Surgery and Burn

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 11, 2024
• Study Start: June 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)