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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brachial plexus pulsed radiofrequency group | Other | Patients will receive pulsed radiofrequency of brachial plexus with steroids injection. |
|
| Sholder individual nerves pulsed radiofrequency group | Other | Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection. |
|
| 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachial plexus pulsed radiofrequency | Other | Patients will receive pulsed radiofrequency of brachial plexus with steroids injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks post postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks post postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmina S Ismail, Master | Contact | 00201223014453 | Yasminasayed.Ys@icloud.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 11796 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author
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| Sholder individual nerves pulsed radiofrequency | Other | Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection. |
|
| Control | Other | 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 . |
|
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| Analgesic consumption |
Analgesic consumption will be recorded |
| 24 weeks post postoperatively |
| Patient satisfaction | Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed | 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. | 24 weeks post postoperatively |
| Incidence of complications | Incidence of complications will be recorded | 24 weeks post postoperatively |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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