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Status unknownNCT06452615Updated Aug 27, 2024

Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

An interventional study of Extracorporeal shockwave in Neuropathic Pain, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Neuropathic Pain

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Keywords

  • Shock Wave Therapy
  • Mastectomy
  • Intercostobrachial neuralgia
  • Neuropathic Pain
03

In context

Neuralgia

1,303 studies on the registry are indexed under Neuralgia; 261 are open to participants now.

This study's planned enrollment of 60 is above the median of 52 across 986 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • DeviceExtracorporeal 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

06

What researchers measure

Primary outcomes

  1. Neuropathic Pain

    The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients.

    Time frame: at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).

  2. Range of Motion

    Shoulder Flexion and Abduction will be assessed from supine position

    Time frame: Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).

07

Study locations

1 of 1 sites recruiting
  • from the National Cancer Institute
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06452615
Lead sponsor
Cairo University
Responsible party
Rehab Abutaleb (Faculty of Physical therapy, Department Physical Therapy for Surgery and Burn, Cairo University) — Principal investigator
First posted
Jun 11, 2024
Start date
Jun 15, 2024
Primary completion
Sep 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Aug 27, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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