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

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Recruitment status:
Recruiting
Primary Sponsor:
Royal Infirmary of Edinburgh
Recruitment countries:
United Kingdom
Health condition studied:
Chronic Pain
URL:
Link to the clinical trial website

About the trial

Interventions:
Other: Questionnaire
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    - 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.

    Exclusion Criteria:

    - 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.
  • Age minimum:  18 Years
  • Age maximum:  N/A
  • Gender:  Female
Primary outcomes:
Relationship of intra-epidermal nerve fibre density to the presence of post-mastectomy pain syndrome as assessed by validated questionnaires
Secondary outcomes:
Target sample size:
100
Study type:
Observational
Study design:
Contacts:
  • Name:   Oliver Daly, MBChB
  • Address: 
  • Phone:  0131 242 1000
  • Email:  o.daly@nhs.net
  • Affiliation: 

Technical details

Scientific title:
The Relationship of Intra-epidermal Nerve Fibre Density (IENFD) and Structure to Chronic Post-Mastectomy Pain Syndrome (PMPS)
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT02919891
Secondary ID:
R&D no. 2016/0081
Register:
ClinicalTrials.gov
Date of registration:
25/08/2016
Date of first enrollment:
March 1, 2017
Last refreshed:
22 May 2017

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