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

NCT02919891 | Completed

• 1 other identifier: R&D no. 2016/0081
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intra-epidermal nerve fibre density; IENFD; Chronic Pain; Post-mastectomy; Post-mastectomy pain syndrome; PMPS; Chronic Post-Surgical Pain; CPSP; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Relationship of intra-epidermal nerve fibre density to the presence of post-mastectomy pain syndrome as assessed by validated questionnaires

  From time of original surgery to current date - could be up to 5 years after surgery

Study Arms (2)

Participants with Chronic Pain

Questionnaire results will allow the diagnosis of chronic pain. No intervention will be administered. The results of the IENFD will be compared to the group without chronic pain.

Other: Questionnaire

Participants without Chronic Pain

Questionnaire results will reveal the absence of chronic pain. No intervention will be administered. The results of the IENFD will be compared to the group with chronic pain.

Other: Questionnaire

Interventions

Questionnaire OTHER

Questionnaires

Participants with Chronic Pain; Participants without Chronic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have undergone mastectomy surgery with a Tissue Bank sample stored in the Edinburgh Experimental Cancer Medicine Centre (ECMC) / SAHSC BioResource.

You may qualify if:

• Patient has Tissue Bank sample stored in the Edinburgh Experimental Cancer Medicine Centre (ECMC) / SAHSC BioResource.
• At the time of their surgery, the patient provided written consent for the sample to be used by future researchers and to be contacted by those researchers.
• Patient has undergone surgery for breast cancer.
• Contact details for the patient are available.
• Patient is able to provide informed consent for the questionnaire component of the study.
• Patient is able to complete and return study questionnaires. Telephone support to help complete the study documentation will be provided if requested.

You may not qualify if:

• Patient who had their surgery outwith the timeframe of the original study consent (2006-2012)
• Patients receiving active oncological treatment.
• Patients who have died.
• Patients with cognitive impairment or significant mental health disorder.
• Patients with active complications of their surgical wound site.

Sponsors & Collaborators

• Royal Infirmary of Edinburgh: lead

Study Sites (1)

Oliver Daly

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 29, 2016
• Study Start: March 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)