CompletedPhase 4

Combined Intra-articular Shoulder Injection and Stellate Ganglion Block in Chronic Post-mastectomy Shoulder Pain

Egypt70 participantsStarted 2017-08-01

Plain-language summary

Background and Purpose: Adhesive capsulitis of the shoulder is commonly found in patients after breast cancer treatment. We aimed to determine the effectiveness of combined shoulder joint intra-articular injection of platelet rich plasma (PRP) with stellate ganglion block (SGB) with ketamine \&bupivacaine injection as a new technique for frozen shoulder (FS) management after mastectomy. Methods: Sixty four patients with chronic post-mastectomy shoulder pain and stiffness were randomly allocated into one of two groups: group A; ultrasound guided SGB (1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml) and group B; ultrasound guided SGB plus posterior approach shoulder injection with PRP. Visual analogue score (VAS) at rest and at shoulder movement, range of motions (ROM) of shoulder and disability of arm, shoulder and hand (DASH) questionnaire were recorded.

Who can participate

Age range

18 Years – 64 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * post-mastectomy shoulder pain * age of 18 to less than 65 years Exclusion Criteria: * refusal to participate * Patients with acute shoulder pain (trauma, acute postsurgical pain) * secondary adhesive capsulitis (prior surgery or non-surgically induced states of shoulder affection by adhesive capsulitis) * hypersensitivity to amide local anesthetics * general contraindications to SGB and cardiac and hepatic, renal or respiratory failure.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analogue score

Timeframe: Before injection and 1, 2, 3 months after injection

Trial details

NCT IDNCT03586154

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-02

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