Pulsed RadiofrequencyNCT07002944
Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain
A study testing Brachial plexus pulsed radiofrequency and Sholder individual nerves pulsed radiofrequency in people with Pulsed Radiofrequency and Shoulder Individual Nerves Brachial Plexus, run by Cairo University at 1 site in Egypt.
Trial summary
this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus, Chronic
- What is being tested?
- Brachial plexus pulsed radiofrequency and Sholder individual nerves pulsed radiofrequency
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2025to 30 Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18-65) Years.
- American Society of Anesthesiologists (ASA) physical status (II- III).
- Patients with post mastectomy shoulder pain.
- Body mass index (BMI): (20-40) kg/m2.
- Patients on maximum daily dose tramadol ( 450mg ) and still in pain
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
Cairo University
Cairo, 11796
Yasmina S Ismail, 00201223014453, Yasminasayed.Ys@icloud.com
Algohary M Tantawy, MD
About this study
Official title: Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study
this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain.
Read the detailed description
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.
Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .
- Conditions
- Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus, Chronic, Post Mastectomy, Shoulder Pain
- Being tested
- Brachial plexus pulsed radiofrequency, Sholder individual nerves pulsed radiofrequency, Control
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial plexus pulsed radiofrequencyOther
Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.
Sholder individual nerves pulsed radiofrequencyOther
Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.
ControlOther
Also called Paracetamol +pregabalin +oxycodone
Patients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs .
| Study group | Role | What they receive |
|---|---|---|
| Brachial plexus pulsed radiofrequency group | Other | Patients will receive pulsed radiofrequency of brachial plexus with steroids injection. Receives: Other: Brachial plexus pulsed radiofrequency |
| Sholder individual nerves pulsed radiofrequency group | Other | Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection. Receives: Other: Sholder individual nerves pulsed radiofrequency |
| Control group | Active comparator | Patients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs . Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visual Analogue Scale (VAS )
Changes in visual Analogue Scale (VAS )for assessment of pain relief. A 100 mm horizontal line version will be used with 2 ends (left-end means no pain and right-end means the worst pain). This version is preferred in research studies for chronic pain status.
Measured: 24 weeks post postoperatively
Secondary outcomes (5)
Functional improvement
This is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into 4 categories (0-25%) ≈ no or minimal functional improvement, (> 25- 50%) ≈ mild improvement, (> 50-75%) ≈ moderate improvement, and (>75-100%) ≈ marked improvement.
Measured: 24 weeks post postoperatively
Analgesic consumption
Analgesic consumption will be recorded
Measured: 24 weeks post postoperatively
Patient satisfaction
Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed
Measured: 24 weeks post postoperatively
The impact of treatment on the quality of life of the patient
The impact of treatment on the quality of life of the patient, which will be assessed by the SF-36 questionnaire.
Measured: 24 weeks post postoperatively
Incidence of complications
Incidence of complications will be recorded
Measured: 24 weeks post postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start3 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulsed RadiofrequencyStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmina Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002944
- Sponsor's protocol ID
- AP2412-201-087-194
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07002944
- Acronym / sponsor ID
- AP2412-201-087-194
- Conditions
- Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus, Chronic, Post Mastectomy, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Jun 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.
this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain.
Detailed description
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.
Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brachial plexus pulsed radiofrequency group | Other | Other: Brachial plexus pulsed radiofrequencyPatients will receive pulsed radiofrequency of brachial plexus with steroids injection. |
| Sholder individual nerves pulsed radiofrequency group | Other | Other: Sholder individual nerves pulsed radiofrequencyPatients will receive shoulder individual nerves pulsed radiofrequency with steroids injection. |
| Control group | Active comparator | Other: ControlPatients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age (18-65) Years.
- American Society of Anesthesiologists (ASA) physical status (II- III).
- Patients with post mastectomy shoulder pain.
- Body mass index (BMI): (20-40) kg/m2.
- Patients on maximum daily dose tramadol ( 450mg ) and still in pain
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 |
|---|---|---|
| Brachial plexus pulsed radiofrequencyPatients will receive pulsed radiofrequency of brachial plexus with steroids injection. | Other | Brachial plexus pulsed radiofrequency group |
| Sholder individual nerves pulsed radiofrequencyPatients will receive shoulder individual nerves pulsed radiofrequency with steroids injection. | Other | Sholder individual nerves pulsed radiofrequency group |
| ControlAlso: Paracetamol +pregabalin +oxycodonePatients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs . | Other | Control group |
Primary outcome
Changes in visual Analogue Scale (VAS )
Time frame: 24 weeks post postoperatively
Changes in visual Analogue Scale (VAS )for assessment of pain relief. A 100 mm horizontal line version will be used with 2 ends (left-end means no pain and right-end means the worst pain). This version is preferred in research studies for chronic pain status.
5 secondary outcomes
Functional improvement
Time frame: 24 weeks post postoperatively
Analgesic consumption
Time frame: 24 weeks post postoperatively
Patient satisfaction
Time frame: 24 weeks post postoperatively
The impact of treatment on the quality of life of the patient
Time frame: 24 weeks post postoperatively
Incidence of complications
Time frame: 24 weeks post postoperatively
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 4 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Brachial plexus pulsed radiofrequency and Sholder individual nerves pulsed radiofrequency in people with Pulsed Radiofrequency and Shoulder Individual Nerves Brachial Plexus, 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 5 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 4 Jun 2025. 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 Yasmina S Ismail, Master (00201223014453, Yasminasayed.Ys@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in visual Analogue Scale (VAS ) (time frame: 24 weeks post postoperatively). 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 4 Jun 2025.