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NCT03586154

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

Completed Phase 4 Last updated 16 July 2018
What this trial tests

Phase 4 trial testing Platelet rich plasma in Breast Neoplasms in 70 participants. Completed in 2 April 2018.

Timeline
1 August 2017
Primary endpoint
2 January 2018
2 April 2018

Quick facts

Lead sponsorMansoura University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment70
Start date1 August 2017
Primary completion2 January 2018
Estimated completion2 April 2018
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Mansoura University

Who can join

Adults 18 to 64, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Prognosis of Arthrofibroses: Prevalence, Clinical Shortcomings, and Future Prospects.
    Blessing WA, Williamson AK, Kirsch JR, Grinstaff MW. · · 2021 · cited 12× · PMID 33795150 · DOI 10.1016/j.tips.2021.02.007

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Other trials of Platelet rich plasma

Trials testing the same drug.

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

Other Mansoura University trials

Trials by the same sponsor.

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