Breast CancerNCT07095569
Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain
A study testing (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF. and conservative treatment in people with Breast Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post mastectomy pain syndrome . Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF. and conservative treatment
- 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
- 1 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18-65) Years.
- ASA physical status (II- III).
- Patients with post mastectomy irradiation shoulder pain.
- Body mass index (BMI): (20-40) kg/m2.
Who cannot join
- Patient refusal.
- Known sensitivity or contraindication to drugs used in the study.
- Pregnancy.
- Recent myocardial infarction.
- Hemodynamically unstable.
- Local and systemic sepsis.
- Psychiatric illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer institute
Cairo, Cairo Governorate, 002
suzan Adlan Khedr, MD, 01111068300, dr_s.adlan@hotmail.com
About this study
Official title: Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial
Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post mastectomy pain syndrome .
After breast cancer surgery, between 6% and 86% of people may develop tight bands of fibrous tissue under their skin, known as axillary web syndrome. These bands can cause pain in the shoulder area by trying to raise or extend the arm. Shoulder pain is a common side effect of breast cancer surgery and treatment.
Read more
Various medical and interventional procedures have been tried for treating postmastectomy shoulder pain, with varying efficacy . Among the interventional procedures that may have a role for treatment.
Innervation of the glenohumeral joint (GHJ) can be divided into anterior and posterior innervation from articular branches of the suprascapular nerve (SN):C5 \&6 (posterior-lateral), axillary nerve (AN):C5 \&6 (anterior-lateral, inferior, and posteriorlateral), and lateral pectoral nerve (LPN): C5 \&6 (anterior superior)
Read the detailed description
The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.
- Conditions
- Breast Cancer
- Being tested
- (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF., conservative treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.Device
Shoulder individual nerves thermal RF technique: The patient will be put in the sitting position, monitored with electrocardiography, pulse oximetry, and non-invasive blood pressure. after disinfection A high-frequency linear transducer (10-15 Hz) will be placed parallel and cephalad to the spine of the scapula. The probe will be moved from cephalad to caudad until the trapezius and supraspinatus muscles were identified. The suprascapular nerve will be identified as a hyperechogenic structure in the suprascapular fossa deep to the superior transverse scapular ligament. A 10 cm radiofrequency needle, with a 10 mm active tip, will be inserted in plane with the ultrasound beam and advanced to reach the proximity to the nerve. A nerve stimulator was used as an additional nerve-finding modality.
conservative treatmentDrug
Patients will receive conservative treatment Acetaminophen (paracetamol 1000 mg tid and pregabalin (lyrica) 75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i | Experimental | Thermal RF therapy will be performed under ultrasound guidance and flouroscopic guidance. Receives: Device: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF. |
| Group 2 (Control): Patients will receive conservative treatment. | Active comparator | Patients will receive conservative treatment Acetaminophen (paracetamol) 1000 mg tid and pregabalin (lyrica)75 mg bid; can be increased, oxycodone (oxynorm) 10mg IR PRN. Receives: Drug: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the changes in NPRS (numerical pain rating scale) for assessment of pain relief which will be recorded before treatment and at 1 month, 2 months and 3-month intervals following treatment.
numerical pain rating scale is a measurement tool that uses numbers to represent the intensity of a characteristic or quality, where 0 might represent "no pain" and 100 the highest number represents "the worst pain imaginable".
Measured: 1 month, 2 months and 3-month intervals following treatment.
Secondary outcomes (1)
Measure oxycodone IR (immediate release) consumption
Measured: 1 month, 2 months and 3-month intervals following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzan Adlan Abdelrahman, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095569
- Sponsor's protocol ID
- IORG003381
- Status last verified
- May 2026
- First submitted
- 15 Jul 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07095569
- Acronym / sponsor ID
- IORG003381
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 31 Jul 2025 (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.
Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post mastectomy pain syndrome .
After breast cancer surgery, between 6% and 86% of people may develop tight bands of fibrous tissue under their skin, known as axillary web syndrome. These bands can cause pain in the shoulder area by trying to raise or extend the arm. Shoulder pain is a common side effect of breast cancer surgery and treatment.
Various medical and interventional procedures have been tried for treating postmastectomy shoulder pain, with varying efficacy . Among the interventional procedures that may have a role for treatment.
Innervation of the glenohumeral joint (GHJ) can be divided into anterior and posterior innervation from articular branches of the suprascapular nerve (SN):C5 \&6 (posterior-lateral), axillary nerve (AN):C5 \&6 (anterior-lateral, inferior, and posteriorlateral), and lateral pectoral nerve (LPN): C5 \&6 (anterior superior)
Detailed description
The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i | Experimental | Device: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.Thermal RF therapy will be performed under ultrasound guidance and flouroscopic guidance. |
| Group 2 (Control): Patients will receive conservative treatment. | Active comparator | Drug: conservative treatmentPatients will receive conservative treatment Acetaminophen (paracetamol) 1000 mg tid and pregabalin (lyrica)75 mg bid; can be increased, oxycodone (oxynorm) 10mg IR PRN. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age (18-65) Years.
- ASA physical status (II- III).
- Patients with post mastectomy irradiation shoulder pain.
- Body mass index (BMI): (20-40) kg/m2.
Key exclusion criteria (7 listed)
- Patient refusal.
- Known sensitivity or contraindication to drugs used in the study.
- Pregnancy.
- Recent myocardial infarction.
- Hemodynamically unstable.
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 |
|---|---|---|
| (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.Shoulder individual nerves thermal RF technique: The patient will be put in the sitting position, monitored with electrocardiography, pulse oximetry, and non-invasive blood pressure. after disinfection A high-frequency linear transducer (10-15 Hz) will be placed parallel and cephalad to the spine of the scapula. The probe will be moved from cephalad to caudad until the trapezius and supraspinatus muscles were identified. The suprascapular nerve will be identified as a hyperechogenic structure in the suprascapular fossa deep to the superior transverse scapular ligament. A 10 cm radiofrequency needle, with a 10 mm active tip, will be inserted in plane with the ultrasound beam and advanced to reach the proximity to the nerve. A nerve stimulator was used as an additional nerve-finding modality. | Device | Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i |
| conservative treatmentPatients will receive conservative treatment Acetaminophen (paracetamol 1000 mg tid and pregabalin (lyrica) 75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN. | Drug | Group 2 (Control): Patients will receive conservative treatment. |
Primary outcome
Assess the changes in NPRS (numerical pain rating scale) for assessment of pain relief which will be recorded before treatment and at 1 month, 2 months and 3-month intervals following treatment.
Time frame: 1 month, 2 months and 3-month intervals following treatment.
numerical pain rating scale is a measurement tool that uses numbers to represent the intensity of a characteristic or quality, where 0 might represent "no pain" and 100 the highest number represents "the worst pain imaginable".
1 secondary outcome
Measure oxycodone IR (immediate release) consumption
Time frame: 1 month, 2 months and 3-month intervals following treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF. and conservative treatment in people with Breast Cancer, run by National Cancer Institute, Egypt 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact suzan Adlan (+201111068300, dr_s.adlan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the changes in NPRS (numerical pain rating scale) for assessment of pain relief which will be recorded before treatment and at 1 month, 2 months and 3-month intervals following treatment. (time frame: 1 month, 2 months and 3-month intervals following treatment.). 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 13 May 2026.