Neuropathic PainNCT06452615
Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy
A study testing Extracorporeal shockwave in people with Neuropathic Pain, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Extracorporeal shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current metastases.
- Continuing radiotherapy or chemotherapy.
- History of allergy to coupling agent.
- Chronic inflammatory diseases and cellulitis.
- Venous thrombosis.
- Local infections.
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- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
from the National Cancer Institute
Cairo
Rehab Abotaleb, 00201023702370, ehabkamelpop@gmail.com
About this study
Official title: 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.
Read more
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:
- The 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, and 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 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:
- 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).
Outcomes:
- ROM of the shoulder joint for flexion and extension
- Level of pain
- Conditions
- Neuropathic Pain
- Being tested
- Extracorporeal shockwave
- Keywords
- Shock Wave Therapy, Mastectomy, Intercostobrachial neuralgia, Neuropathic Pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwaveDevice
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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | They will receive Extracorporeal shockwave therapy (ESWT), two session per week for 8 weeks in addition to the routine medical treatment. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain
The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients.
Measured: 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
Measured: Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start15 Jun 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abutaleb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452615
- Sponsor's protocol ID
- No:P.T.REC/012/004573
- Status last verified
- Aug 2024
- First submitted
- 17 May 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy
- ClinicalTrials.gov ID
- NCT06452615
- Acronym / sponsor ID
- No:P.T.REC/012/004573
- Conditions
- Neuropathic Pain
- Keywords
- Shock Wave Therapy, Mastectomy, Intercostobrachial neuralgia, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The 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, and 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 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:
- 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).
Outcomes:
- ROM of the shoulder joint for flexion and extension
- Level of pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Extracorporeal shockwaveThey will receive Extracorporeal shockwave therapy (ESWT), two session per week for 8 weeks in addition to the routine medical treatment. |
| 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Current metastases.
- Continuing radiotherapy or chemotherapy.
- History of allergy to coupling agent.
- Chronic inflammatory diseases and cellulitis.
- Venous thrombosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shockwaveThe 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 | Device | Study group |
Primary outcome
Neuropathic Pain
Time frame: at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).
The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients.
Range of Motion
Time frame: Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).
Shoulder Flexion and Abduction will be assessed from supine position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave in people with Neuropathic Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain (time frame: at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.