SciaticaNCT02512081
"The Lived Experience of Investigations for Sciatica"
An observational study of Sciatica, run by University of Southampton.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Previous spinal surgery Sciatica caused by sinister pathology or Cauda Equina Syndrome
About this study
Official title: "The Lived Experience of Investigations in Sciatica"
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.
Read the 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.
- Conditions
- Sciatica
- Being tested
- No intervention applied
- Keywords
- Sciatica, Patient Experience, Investigations, Qualitative Research
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention appliedOther
No intervention applied
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience
Patient experience gained through semi-structured interview
Measured: Within 6 weeks of receiving investigation results for sciatica
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Solent NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lisa Roberts, Associate Professor, Study chair, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512081
- Sponsor's protocol ID
- UOS-2307-CR
- Status last verified
- Jul 2015
- First submitted
- 29 Jul 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Lived Experience of Investigations in Sciatica"
- ClinicalTrials.gov ID
- NCT02512081
- Acronym / sponsor ID
- UOS-2307-CR
- Conditions
- Sciatica
- Keywords
- Sciatica, Patient Experience, Investigations, Qualitative Research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Solent NHS Trust
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Previous spinal surgery Sciatica caused by sinister pathology or Cauda Equina Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention appliedNo intervention applied | Other | – |
Primary outcome
Patient Experience
Time frame: Within 6 weeks of receiving investigation results for sciatica
Patient experience gained through semi-structured interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
Related trials for Sciatica
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Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
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Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
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Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
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Randomized Evaluation of Lumbar Injection Effectiveness and Function
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Roberts, Associate Professor study chair
University of Southampton
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica, run by University of Southampton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Experience (time frame: Within 6 weeks of receiving investigation results for sciatica). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.