NCT05458154 — Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes · CancerIndex
Clinical trial · Interventional
Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes
Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain After Pain Management Protocol of Physiotherapy
The purpose of the Breast Cancer EDGE Task Force is to provide physiotherapists with a comprehensive list of outcome measures that can be administered to a selected patient population, to assess post-mastectomy pain syndrome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Post-mastectomy Pain Syndrome
—
UNRESOLVED
—
Interventions
Interventions (1)
Intervention
Type
Mapped drug
Match
questionnaires
Other
—
UNRESOLVED
Design
Arms and outcomes
Arms (1)
type
EXPERIMENTAL
label
Experimental group
description
Seven of the 22 pain measures demonstrated satisfactory psychometric properties and clinical utility and are thereby recommended for clinical and research use in adults with a diagnosis of cancer.
Participants received Physical therapy program is critical to preserve flexibility, strength, range of motion, and normal neuromuscular recruitment. Patients' efforts to cut back their pain through avoidance behaviors can severely undermine function if mobility, activity of daily living, performance, or vocational capacity are affected. Physical therapy may involve trials of analgesic modalities like desensitization techniques, transcutaneous electrical nerve stimulation (TENS), and topical cold. Modality trials are rapid, relatively harmless, and inexpensive with the additional benefit that patients can self-administer effective treatments The pain management protocol of physiotherapy of PMPS depends mainly on education regarding the subsequent points that are paramount.
interventionNames
Other: questionnaires
Primary outcomes (3)
measure
McGill Pain Questionnaire-Short Form
timeFrame
baseline
description
15-word descriptors that describe two dimensions of pain: sensory and affective.
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Maximum age
70 Years
Show eligibility criteria text
Inclusion Criteria:
* Chronic pain \>= 3 months
* Pain is localized to the chest wall or axilla.
* The onset of pain is clearly after surgery or radiation therapy.
* Pain is persistent, not fluctuating.
* The patient is a minimum of 6 weeks post-radiation therapy.
Exclusion Criteria:
* Time since surgery was less than 6 months.
* The pain wasn't presented as an outcome, previous ipsilateral breast cancer, pregnancy, disease within the nervous system, psychiatric disease.
* Time since diagnosis was less than 1 year.
References
Publications (52)
BACKGROUNDSiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. PMID 35020204
BACKGROUNDKudel I, Edwards RR, Kozachik S, Block BM, Agarwal S, Heinberg LJ, Haythornthwaite J, Raja SN. Predictors and consequences of multiple persistent postmastectomy pains. J Pain Symptom Manage. 2007 Dec;34(6):619-27. doi: 10.1016/j.jpainsymman.2007.01.013. Epub 2007 Jul 16. PMID 17629668
BACKGROUNDPoleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007. PMID 16942948
BACKGROUNDPeuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16. PMID 18635381
BACKGROUNDArman M, Rehnsfeldt A, Lindholm L, Hamrin E. The face of suffering among women with breast cancer-being in a field of forces. Cancer Nurs. 2002 Apr;25(2):96-103. doi: 10.1097/00002820-200204000-00003. PMID 11984096
BACKGROUNDGartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. PMID 19903919
BACKGROUNDFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
measure
Numeric Rating Scale
timeFrame
baseline
description
the most ordinarily used one is the 11-item version, the rating of pain from (0 - 10).
measure
Visual Analog Scale
timeFrame
baseline
description
is a 10 cm-long horizontal line with the words "no pain" at one end and "pain as bad as it can be" at the other.
Secondary outcomes (4)
measure
Brief Pain Inventory
timeFrame
baseline
description
There's a complete of 32 items on the Brief Pain Inventory, it describes pain interferes with 7 domains of function within the last 24 hours:
general activity, mood, walking ability, normal work, relations with people, sleep, and pleasure of life using a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
measure
Brief Pain Inventory-Short Form
timeFrame
baseline
description
is a tool developed specifically to be used in individuals with cancer.
measure
McGill Pain Questionnaire
timeFrame
baseline
description
is a unique measure because it assesses pain using a multidimensional approach based on the gate control theoretical framework.
contains three major classes of word descriptors: sensory, affective, and evaluative.
measure
Pain Disability Index
timeFrame
baseline
description
is a multidimensional tool designed to measure the degree to of chronic pain affects an individual's ability to perform a variety of activities.
The PDI contains seven categories: family/home responsibility, recreation, social activity, occupation, sexual behavior, self-care, and life support activity.
BACKGROUNDAndersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24. PMID 21435953
BACKGROUNDCheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782. PMID 17457830
BACKGROUNDAssa J. The intercostobrachial nerve in radical mastectomy. J Surg Oncol. 1974;6(2):123-6. doi: 10.1002/jso.2930060206. No abstract available. PMID 4822897
BACKGROUNDCunnick GH, Upponi S, Wishart GC. Anatomical variants of the intercostobrachial nerve encountered during axillary dissection. Breast. 2001 Apr;10(2):160-2. doi: 10.1054/brst.2000.0226. PMID 14965578
BACKGROUNDLoukas M, Hullett J, Louis RG Jr, Holdman S, Holdman D. The gross anatomy of the extrathoracic course of the intercostobrachial nerve. Clin Anat. 2006 Mar;19(2):106-11. doi: 10.1002/ca.20226. PMID 16470542
BACKGROUNDWallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3. PMID 8880841
BACKGROUNDAndersen KG, Duriaud HM, Kehlet H, Aasvang EK. The Relationship Between Sensory Loss and Persistent Pain 1 Year After Breast Cancer Surgery. J Pain. 2017 Sep;18(9):1129-1138. doi: 10.1016/j.jpain.2017.05.002. Epub 2017 May 11. PMID 28502878
BACKGROUNDGlare PA, Davies PS, Finlay E, Gulati A, Lemanne D, Moryl N, Oeffinger KC, Paice JA, Stubblefield MD, Syrjala KL. Pain in cancer survivors. J Clin Oncol. 2014 Jun 1;32(16):1739-47. doi: 10.1200/JCO.2013.52.4629. Epub 2014 May 5. PMID 24799477
BACKGROUNDAhmed A, Bhatnagar S, Rana SP, Ahmad SM, Joshi S, Mishra S. Prevalence of phantom breast pain and sensation among postmastectomy patients suffering from breast cancer: a prospective study. Pain Pract. 2014 Feb;14(2):E17-28. doi: 10.1111/papr.12089. Epub 2013 Jun 24. PMID 23789788
BACKGROUNDVecht CJ, Van de Brand HJ, Wajer OJ. Post-axillary dissection pain in breast cancer due to a lesion of the intercostobrachial nerve. Pain. 1989 Aug;38(2):171-6. doi: 10.1016/0304-3959(89)90235-2. PMID 2780072
BACKGROUNDJung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available. PMID 12855309
BACKGROUNDMacdonald 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. doi: 10.1038/sj.bjc.6602304. PMID 15655557
BACKGROUNDLeysen L, Beckwee D, Nijs J, Pas R, Bilterys T, Vermeir S, Adriaenssens N. Risk factors of pain in breast cancer survivors: a systematic review and meta-analysis. Support Care Cancer. 2017 Dec;25(12):3607-3643. doi: 10.1007/s00520-017-3824-3. Epub 2017 Aug 10. PMID 28799015
BACKGROUNDTreede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14. PMID 18003941
BACKGROUNDHaroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010. PMID 23273105
BACKGROUNDBorsook D, Kussman BD, George E, Becerra LR, Burke DW. Surgically induced neuropathic pain: understanding the perioperative process. Ann Surg. 2013 Mar;257(3):403-12. doi: 10.1097/SLA.0b013e3182701a7b. PMID 23059501
BACKGROUNDStevens PE, Dibble SL, Miaskowski C. Prevalence, characteristics, and impact of postmastectomy pain syndrome: an investigation of women's experiences. Pain. 1995 Apr;61(1):61-68. doi: 10.1016/0304-3959(94)00162-8. PMID 7644250
BACKGROUNDJensen MP, Chodroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology. 2007 Apr 10;68(15):1178-82. doi: 10.1212/01.wnl.0000259085.61898.9e. PMID 17420400
BACKGROUNDJung BF, Herrmann D, Griggs J, Oaklander AL, Dworkin RH. Neuropathic pain associated with non-surgical treatment of breast cancer. Pain. 2005 Nov;118(1-2):10-4. doi: 10.1016/j.pain.2005.09.014. Epub 2005 Oct 4. No abstract available. PMID 16213086
BACKGROUNDBefort CA, Klemp J. Sequelae of breast cancer and the influence of menopausal status at diagnosis among rural breast cancer survivors. J Womens Health (Larchmt). 2011 Sep;20(9):1307-13. doi: 10.1089/jwh.2010.2308. Epub 2011 Jun 28. PMID 21711155
BACKGROUND30. Miale S, Harrington S, Kendig T. Oncology Section Task Force on Breast Cancer Outcomes: Clinical measures of upper extremity function. Rehabil Oncol. 2013;31(1):27-34.
BACKGROUNDWaltho 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. doi: 10.1503/cjs.000716. PMID 27668333
BACKGROUNDChappell AG, Bai J, Yuksel S, Ellis MF. Post-Mastectomy Pain Syndrome: Defining Perioperative Etiologies to Guide New Methods of Prevention for Plastic Surgeons. World J Plast Surg. 2020 Sep;9(3):247-253. doi: 10.29252/wjps.9.3.247. PMID 33329999
BACKGROUNDPerkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. PMID 11020770
BACKGROUNDSmith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7. PMID 10506676
BACKGROUND35. Keith R. Lohse, PhD, Catherine E. Lang, PT PhD, and Lara A. Boyd PP, Hendrix, Abernethy, Sloane, Misuraca & M. 基因的改变NIH Public Access. Bone. 2013;23(1):1-7.
BACKGROUND36. Smith BG, Head JSLC opinion in otolaryngology, 2010. The role of lymphedema management in head and neck cancer. NcbiNlmNihGov [Internet]. 2017;32(1):1-18. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4111092/
BACKGROUNDSchou Bredal I, Smeby NA, Ottesen S, Warncke T, Schlichting E. Chronic pain in breast cancer survivors: comparison of psychosocial, surgical, and medical characteristics between survivors with and without pain. J Pain Symptom Manage. 2014 Nov;48(5):852-62. doi: 10.1016/j.jpainsymman.2013.12.239. Epub 2014 Apr 2. PMID 24703940
BACKGROUNDAndersen KG, Aasvang EK, Kroman N, Kehlet H. Intercostobrachial nerve handling and pain after axillary lymph node dissection for breast cancer. Acta Anaesthesiol Scand. 2014 Nov;58(10):1240-8. doi: 10.1111/aas.12393. PMID 25307709
BACKGROUND40. St. Louis MS. Pathology: Implications for the physical therapist. Elsevier..(3rd ed.). 2009.
BACKGROUND41. Sleigh BC MB. Lymphedema. InStatPearls [Internet] 2019 . [Internet]. 2019. Available from: https://www.ncbi.nlm.nih.gov/books/NBK537239/
BACKGROUND42. Lymphoedema. [Internet]. Physiopedia. 2021. Available from: https://www.physio-pedia.com/Lymphoedema
BACKGROUND43. American Cancer Society | Information and Resources about for Cancer: Breast, Colon, Lung, Prostate, Skin. /www.cancer.org/> [Internet]. Cancer.org. 2021. Available from: https://www.cancer.org/
BACKGROUND44. April U. Oncology Section EDGE Task Force Report Summaries Colon Cancer Outcomes Authors Urogenital Cancer Outcome Measures. 2018;(August 2015):1-10.
BACKGROUNDHo K, Spence J, Murphy MF. Review of pain-measurement tools. Ann Emerg Med. 1996 Apr;27(4):427-32. doi: 10.1016/s0196-0644(96)70223-8. No abstract available. PMID 8604852
BACKGROUNDLowe NK, Walker SN, MacCallum RC. Confirming the theoretical structure of the McGill Pain Questionnaire in acute clinical pain. Pain. 1991 Jul;46(1):53-60. doi: 10.1016/0304-3959(91)90033-T. PMID 1896208
BACKGROUNDDe Gagne TA, Mikail SF, D'Eon JL. Confirmatory factor analysis of a 4-factor model of chronic pain evaluation. Pain. 1995 Feb;60(2):195-202. doi: 10.1016/0304-3959(94)00114-T. PMID 7784105
BACKGROUNDScott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available. PMID 1026900
BACKGROUNDGallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863. PMID 11719741
BACKGROUNDJensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9. PMID 3785962
BACKGROUNDJensen MP. The validity and reliability of pain measures in adults with cancer. J Pain. 2003 Feb;4(1):2-21. doi: 10.1054/jpai.2003.1. PMID 14622723
BACKGROUNDKremer E, Atkinson HJ, Ignelzi RJ. Measurement of pain: patient preference does not confound pain measurement. Pain. 1981 Apr;10(2):241-248. doi: 10.1016/0304-3959(81)90199-8. PMID 7267140
BACKGROUNDFernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-las-Penas C, Del-Moral-Avila R, Menjon-Beltran S, Arroyo-Morales M. Widespread mechanical pain hypersensitivity as a sign of central sensitization after breast cancer surgery: comparison between mastectomy and lumpectomy. Pain Med. 2011 Jan;12(1):72-8. doi: 10.1111/j.1526-4637.2010.01027.x. Epub 2010 Dec 10. PMID 21143767
BACKGROUNDJensen MP, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity measurement? Pain. 1994 Sep;58(3):387-392. doi: 10.1016/0304-3959(94)90133-3. PMID 7838588
BACKGROUNDJensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3. PMID 10534586