NCT02512081

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

July 29, 2015

Last Update Submit

May 11, 2016

Conditions

Keywords

SciaticaPatient ExperienceInvestigationsQualitative Research

Outcome Measures

Primary Outcomes (1)

  • Patient Experience

    Patient experience gained through semi-structured interview

    Within 6 weeks of receiving investigation results for sciatica

Interventions

No intervention applied

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa Roberts, Associate Professor

    University of Southampton

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

July 30, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

October 1, 2016

Last Updated

May 12, 2016

Record last verified: 2015-07