"The Lived Experience of Investigations for Sciatica"
Primary Purpose
Sciatica
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
No intervention applied
Sponsored by
About this trial
This is an observational trial for Sciatica focused on measuring Sciatica, Patient Experience, Investigations, Qualitative Research
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
Sites / Locations
Outcomes
Primary Outcome Measures
Patient Experience
Patient experience gained through semi-structured interview
Secondary Outcome Measures
Full Information
NCT ID
NCT02512081
First Posted
July 29, 2015
Last Updated
May 11, 2016
Sponsor
University of Southampton
Collaborators
Solent NHS Trust
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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