Prediction of Persistent Post-Mastectomy Pain

NCT02329574 | Completed

• 1 other identifier: 2013P002202
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that individual person-specific factors may play a more important role. In fact, recent studies indicate that individual differences in pain sensitivity (psychophysics) are more closely associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed that women who developed PPMP had lower pressure pain thresholds and greater temporal summation of pain stimuli than women who did not develop this chronic pain condition. Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization were more prominent in women with PPMP. These preliminary, retrospective studies suggest that individual psychophysical and psychosocial characteristics could be important risk factors for PPMP. Accordingly, the aim of this study is to comprehensively and prospectively study women having mastectomy surgery, to determine the relationship between pre-operative psychophysical and psychosocial factors and the development of PPMP. Using these data, a prediction model for PPMP will be developed, thus allowing a preoperative calculation of a "PPMP risk score" for any patient facing mastectomy.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Persistent mastectomy pain

  based the breast cancer pain questionnaire, which assesses multiple related body areas, severity and frequency of pain

  1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing partial or total mastectomy

You may qualify if:

• Female
• Aged 18-80 years
• Scheduled for total or partial mastectomy
• Willingness to undergo psychophysical and psychosocial testing
• Willingness to participate in long-term follow-up

You may not qualify if:

• Scheduled for biopsy only
• Pregnant

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Zinboonyahgoon N, Vlassakov K, Lirk P, Spivey T, King T, Dominici L, Golshan M, Strichartz G, Edwards R, Schreiber K. Benefit of regional anaesthesia on postoperative pain following mastectomy: the influence of catastrophising. Br J Anaesth. 2019 Aug;123(2):e293-e302. doi: 10.1016/j.bja.2019.01.041. Epub 2019 Mar 28.

  PMID: 31331591 DERIVED

• Schreiber KL, Zinboonyahgoon N, Xu X, Spivey T, King T, Dominici L, Partridge A, Golshan M, Strichartz G, Edwards RR. Preoperative Psychosocial and Psychophysical Phenotypes as Predictors of Acute Pain Outcomes After Breast Surgery. J Pain. 2019 May;20(5):540-556. doi: 10.1016/j.jpain.2018.11.004. Epub 2018 Nov 23.

  PMID: 30476655 DERIVED

Biospecimen

Retention: NONE RETAINED

saliva

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty, Department of Anesthesiology

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)