Breast Neoplasms Clinical Trial
Official title:
Combined Platelet Rich Plasma Intra-articular Shoulder Injection and Stellate Ganglion Block. A New Technique for Management of Chronic Post-mastectomy Shoulder Pain Syndrome
Verified date | July 2018 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 2, 2018 |
Est. primary completion date | January 2, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | MansouraU | Mansourah | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Aslani H, Nourbakhsh ST, Zafarani Z, Ahmadi-Bani M, Ananloo ME, Beigy M, Salehi S. Platelet-Rich Plasma for Frozen Shoulder: A Case Report. Arch Bone Jt Surg. 2016 Jan;4(1):90-3. — View Citation
Ebaugh D, Spinelli B, Schmitz KH. Shoulder impairments and their association with symptomatic rotator cuff disease in breast cancer survivors. Med Hypotheses. 2011 Oct;77(4):481-7. doi: 10.1016/j.mehy.2011.06.015. Epub 2011 Jul 18. — View Citation
Kulkarni KR, Kadam AI, Namazi IJ. Efficacy of stellate ganglion block with an adjuvant ketamine for peripheral vascular disease of the upper limbs. Indian J Anaesth. 2010 Nov;54(6):546-51. doi: 10.4103/0019-5049.72645. — View Citation
Leonidou A, Woods DA. A preliminary study of manipulation under anaesthesia for secondary frozen shoulder following breast cancer treatment. Ann R Coll Surg Engl. 2014 Mar;96(2):111-5. doi: 10.1308/003588414X13824511649652. — View Citation
Lipov EG, Joshi JR, Sanders S, Slavin KV. A unifying theory linking the prolonged efficacy of the stellate ganglion block for the treatment of chronic regional pain syndrome (CRPS), hot flashes, and posttraumatic stress disorder (PTSD). Med Hypotheses. 2009 Jun;72(6):657-61. doi: 10.1016/j.mehy.2009.01.009. Epub 2009 Feb 23. — View Citation
Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. — View Citation
Peng PW, Cheng P. Ultrasound-guided interventional procedures in pain medicine: a review of anatomy, sonoanatomy, and procedures. Part III: shoulder. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):592-605. doi: 10.1097/AAP.0b013e318231e068. Review. — View Citation
Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1. — View Citation
Stubblefield MD, Custodio CM. Upper-extremity pain disorders in breast cancer. Arch Phys Med Rehabil. 2006 Mar;87(3 Suppl 1):S96-9; quiz S100-1. Review. — View Citation
Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. Review. — View Citation
Yang S, Park DH, Ahn SH, Kim J, Lee JW, Han JY, Kim DK, Jeon JY, Choi KH, Kim W. Prevalence and risk factors of adhesive capsulitis of the shoulder after breast cancer treatment. Support Care Cancer. 2017 Apr;25(4):1317-1322. doi: 10.1007/s00520-016-3532-4. Epub 2016 Dec 9. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analogue score | Visual analogue score (VAS) was done at rest and at shoulder movement before injection, one, two and three months after injection. VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain. Shoulder mobility was assessed while the patient was sitting using goniometry. | Before injection and 1, 2, 3 months after injection | |
Secondary | Range of motion | It was measured in degrees in five position (extension, flexion, and abduction, internal and external rotation) before and one month after injection. | Before injection and one month after injection | |
Secondary | Disability of arm | shoulder and hand (DASH) questionnaire was done before injection, one, two and three months after injection. | Before injection and 1, 2 , 3 months after injection |
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