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Relationship of Intra-Epidermal Nerve Fibre Density (IENFD) and Structure to Chronic Post-Mastectomy Pain Syndrome (PMPS)

NCT02919891 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2018-04-11

No results posted yet for this study

Summary

This is a retrospective, observational study which will utilise the Edinburgh Cancer Research Centre's Tissue Bank to provide samples for IENFD testing in those who have undergone mastectomy surgery for breast cancer.

The investigators shall identify all those patients in the Tissue Bank database who have undergone mastectomy surgery for breast cancer. The investigators shall consult the patient's electronic health record, and general practitioner if required, to ascertain whether the patient has died, been diagnosed with cognitive impairment or a psychotic disorder, or receiving ongoing oncological treatment which would exclude them from the study. The investigators shall also exclude all those patients who received surgery within the last year as we intend to elucidate the presence of pain in the immediate post-operartive period up to 12 months post-operatively.

Having identified these patients the investigators shall contact them via post with a pack containing an information document, a consent form and questionnaires. As this is an observational study we shall contact all of the identified patients who meet the inclusion criteria with the aim of recruiting as many as possible. The investigators would anticipate a high response rate as has been the experience with previous questionnaire studies of breast cancer patients.

Once a signed consent form has been returned the patient's tissue sample would undergo IENFD testing. Their questionnaire responses will allow participants to be split into two groups based upon whether they experience CPSP or not. Blinding of this grouping will take place so that those undertaking the IENFD testing are unaware of the patient's questionnaire responses.

Statistical analysis of the two group's IEFD results and questionnaire responses will then be undertaken with the null hypothesis that the pre-operative IENFD at the site of surgery does not predict or correlate with CPSP.

Conditions

  • Chronic Pain
  • Pain Measurement
  • Mastectomy
  • Postoperative Pain

Interventions

OTHER

Questionnaire

Questionnaires

Sponsors & Collaborators

  • Royal Infirmary of Edinburgh

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-02-01
Completion
2018-02-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919891 on ClinicalTrials.gov