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Recruiting NCT06452615

Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

No phase Interventional Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extracorporeal shockwave.
Who it may be relevant to
Registry conditions: Neuropathic Pain. Basic parameters: 40 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy

Overview

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

Interventions

  • 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

Primary outcome measures

  • Neuropathic Pain [Time frame: at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).]
  • Range of Motion [Time frame: Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • from the National Cancer Institute — Cairo

Identifiers

NCT: NCT06452615 · No:P.T.REC/012/004573

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗