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"The Lived Experience of Investigations for Sciatica"

Primary Purpose

Sciatica

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
No intervention applied
Sponsored by
University of Southampton
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Sciatica focused on measuring Sciatica, Patient Experience, Investigations, Qualitative Research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of Sciatica (of likely nerve root origin) Have undergone investigations for Sciatica and received results in past 6 weeks Patients who are able to read, write and understand English language instructions

Exclusion Criteria:

Previous spinal surgery Sciatica caused by sinister pathology or Cauda Equina Syndrome

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Patient Experience
    Patient experience gained through semi-structured interview

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2015
    Last Updated
    May 11, 2016
    Sponsor
    University of Southampton
    Collaborators
    Solent NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02512081
    Brief Title
    "The Lived Experience of Investigations for Sciatica"
    Official Title
    "The Lived Experience of Investigations in Sciatica"
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southampton
    Collaborators
    Solent NHS Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This will be an exploratory study, using semi-structured interviews to explore patients' experiences of undergoing investigations for Sciatica (leg pain referred from the lower back). Interviews will be analysed based on an Interpretative Phenomenological Approach (IPA).The end product of analysis will be a detailed account of patients' experiences supported by direct quotes.The intention is that this account will help health-care providers to understand patients' experiences and to plan and provide Sciatica care that is effective, evidence based and acceptable to patients.
    Detailed Description
    Sciatica (leg pain referred from the lower back) is a common problem that causes significant pain and disability. Many patients experience lasting symptoms that do not respond to pain relief or physiotherapy. This group of patients are commonly managed by Spinal Specialists who help determine the best treatment approach and consider if investigations are required. In the United Kingdom (UK), clinical guidelines suggest that imaging for Sciatica is only appropriate for patients who are considered likely to need surgery or when the cause is suspected to be serious such as cancer or infection. Patients who do not meet the criteria for investigations express frustration when clinical tests and opinion alone are used to diagnose and treat Sciatica. Some patients are unable to accept that investigations are not required and loose confidence in treatment. If Sciatica is to be managed effectively, the treatment offered must be acceptable to and successfully negotiated with patients. Little research is currently available regarding patients' expectations or experiences of undergoing investigations for Sciatica. The aim of this study is to explore the experience of patients who have undergone investigations for Sciatica, to gain an understanding of how patients experience investigations as part of their overall management of Sciatica.This study specifically explores the experiences of patients whose Sciatica is likely to be caused by nerve root involvement. This study will be exploratory, based on an Interpretative Phenomenological Approach (IPA). Up to 15 patients who have undergone investigations for Sciatica will be interviewed using a semi-structured format. Patients will be recruited from one National Health Service (NHS) Trust on the South Coast of England. Interviews will be audio-recorded, transcribed verbatim and analysed thematically, based on an IPA approach. The end product of analysis will be a detailed account of patient's experience of investigations, supported by direct quotes. The intention is that this account will help health-care providers to understand patients' experiences and to plan and provide Sciatica care that is effective, evidence based and acceptable to patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sciatica
    Keywords
    Sciatica, Patient Experience, Investigations, Qualitative Research

    7. Study Design

    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    No intervention applied
    Intervention Description
    No intervention applied
    Primary Outcome Measure Information:
    Title
    Patient Experience
    Description
    Patient experience gained through semi-structured interview
    Time Frame
    Within 6 weeks of receiving investigation results for sciatica

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Sciatica (of likely nerve root origin) Have undergone investigations for Sciatica and received results in past 6 weeks Patients who are able to read, write and understand English language instructions Exclusion Criteria: Previous spinal surgery Sciatica caused by sinister pathology or Cauda Equina Syndrome
    Study Population Description
    Adults (aged over 18 years) with a clinical diagnosis of 'Sciatica of likely nerve root origin' who have undergone investigations as part of their conservative management and received results in the past 6 weeks.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa Roberts, Associate Professor
    Organizational Affiliation
    University of Southampton
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    "The Lived Experience of Investigations for Sciatica"

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