19 Harley St, London, W1G 9QJ, UK

Involving Patients And Clinicians In The Development Of A Randomised Clinical Trial Protocol To Assess Spinal Manual Therapy Versus Nerve Root Injection For Patients With Lumbar Radiculopathy: A Patient And Public Involvement Project To Inform The SALuBRITY Trial Design London Spine Nerve Root

The article discusses the SALuBRITY trial, a clinical trial comparing the effectiveness of spinal manual therapy and corticosteroid nerve root injection in treating patients with lumbar radiculopathy. Patient and clinician perspectives were sought to improve the relevance and quality of the trial. Patients and clinicians endorsed the trial’s objectives and found the proposed methods acceptable within the context of a patient-clinician relationship. A recruitment time of up to five days was considered acceptable, although patients with chronic radiculopathy may need more time. Consensus was reached on a medication washout phase and the inclusion of a rescue medication protocol. Leg pain was preferred as the primary clinical outcome, and patients requested additional pain measurement considerations. Patient and clinician advisors found their engagement in the research meaningful and impactful. The findings of patient and public involvement are expected to enhance the trial’s quality and relevance

Summarised by Mr Mo Akmal – Lead Spinal Surgeon
The London Spine Unit : best situated day surgery hospital in UK

Published article

Patient and public involvement resulted in important and relevant considerations for the SALuBRITY trial, spanning all research phases. These findings hold promise for enhancing the trial’s quality and relevance and improving its translation into clinical practice.

Spine nerve root injection dorsal root ganglion transforaminal Expert. Best Spinal Surgeon UK
Abstract Background: Spinal manual therapy and corticosteroid nerve root injection are commonly used to treat patients with lumbar radiculopathy. The SALuBRITY trial-a two parallel group, double sham controlled, randomised clinical trial-is being developed to compare their effectiveness. By gathering patients’ and clinicians’ perspectives and involving them in discussions related to the trial research question and,

Abstract

Background: Spinal manual therapy and corticosteroid nerve root injection are commonly used to treat patients with lumbar radiculopathy. The SALuBRITY trial-a two parallel group, double sham controlled, randomised clinical trial-is being developed to compare their effectiveness. By gathering patients’ and clinicians’ perspectives and involving them in discussions related to the trial research question and objectives, proposed trial recruitment processes, methods, and outcome measures, we aimed to improve the relevance and quality of the SALuBRITY trial.

Methods: We involved patients with lived experience of lumbar radiculopathy (n = 5) and primary care clinicians (n = 4) with experience in the treatment of these patients. Involvement activities included an initial kick-off event to introduce the project, establishing a shared purpose statement, and empowering patient and clinician advisors for their involvement, followed by semi-structured group and individual interviews, and questionnaires to evaluate the experience throughout the project.

Results: Both patient and clinician advisors endorsed the significance and relevance of the trial’s objectives. Patients assessed the proposed trial methods as acceptable within the context of a trusting patient-clinician relationship. A trial recruitment and enrolment target time of up to five days was regarded as acceptable, although patients with chronic radiculopathy may need more time to consider their trial participation decision. All advisors reached consensus on the acceptability of a medication washout phase of 12- to 24-h before pain outcome measurement, with the inclusion of a rescue medication protocol. Both advisory groups preferred leg pain over back pain as the primary clinical outcome, with patient advisors advocating for personalized primary pain localization. Furthermore, patients requested expanding the pain, enjoyment, and general activity scale with peak pain intensity, rather than average pain alone. Patient and clinician advisors evaluated their engagement in clinical research as meaningful and impactful.

Patient and public involvement resulted in important and relevant considerations for the SALuBRITY trial, spanning all research phases. These findings hold promise for enhancing the trial’s quality and relevance and improving its translation into clinical practice.

Keywords: Back pain; Chiropractic; Corticosteroid nerve root injection; Lumbar radiculopathy; Outcome assessment; Patient and public involvement; Patient engagement; Research design; Sciatica; Spinal manual therapy.

The London Spine Unit : best situated day surgery hospital in UK

Read the original publication:

Involving patients and clinicians in the development of a randomised clinical trial protocol to assess spinal manual therapy versus nerve root injection for patients with lumbar radiculopathy: a patient and public involvement project to inform the SALuBRITY trial design

Doctors Specialising in Back Pain Treatment
Mr Purnajyoti Banerjee
Mr. Purnajyoti Banerjee is a consultant in the field of ...

Related Posts

0/5 (0 Reviews)

Trusindex Reviews

London Spine Unit Harley Street Hospital

A Focus on High Quality Specialised Care

We are a specialist Private Hospital based on Harley Street, London UK The Harley Street Hospital, Day Surgery Hospital

We provide exclusive health services for individuals seeking Advanced medical, non-surgical or minimally invasive treatments. We are covered by All Insurance Companies apart from AXA PPP

Our Medical Director and Lead Spinal Surgeon Mr Mo Akmal MD is a world renowned Spine Specialist Consultant with over 20 years of experience. He and his team have developed revolutionary techniques to perform all types of Spinal Surgery as a Day Case procedure without traditional General Anaesthetic.

We are constantly improving our techniques for treatment and improving facilities for our patients.

Book your Appointment Now 
Check out our Reviews 
Check out our Patient Videos 
Check our Mr Akmal’s Profile

 

What our patients say ...

Abstract Background: Spinal manual therapy and corticosteroid nerve root injection are commonly used to treat patients with lumbar radiculopathy. The SALuBRITY trial-a two parallel group, double sham controlled, randomised clinical trial-is being developed to compare their effectiveness. By gathering patients' and clinicians' perspectives and involving them in discussions related to the trial research question and
Injection

Revolutionary Keyhole surgical technique to vaporise bulging discs

Dr Mo Akmal Medical Director
Dr Mo Akmal MD - Lead Spinal Surgeon

Laser Disc Surgery can be performed under local anaesthetic at The Harley Street Hospital.

Initial Consultation

with Consultant Spine Surgeon
£ 250
  • No Waiting Times
  • Top NHS affiliated Consultant
  • Includes Clinical Review and Report
  • Multidisciplinary discussion
  • Review of Previous Scans and Reports

Follow up Consultation

any appointment after initial consultation
£ 180
  • Top NHS affiliated Consultant
  • Includes Clinical Review and Report
  • Multidisciplinary discussion

High Resolution MRI Scan

any Single Region (3.0 Tesla)
£ 600
  • No waiting times
  • Includes Full Radiologist Report
  • Open or Closed MRI scan types
  • Copy of Scan on CD

Website Offer

Pre-Booked Online
£1130
£ 800
  • Initial Consultation
  • MRI Scan (Single Region)
  • Follow Up consultation
  • Same Day One Stop Visit
  • Full Medical and MRI scan Report
  • Copy of scan on CD
Popular

If you have any emergency Doctor’s need, simply call our 24 hour emergency

Your personal case manager will ensure that you receive the best possible care.

Call Now 

+44 844 589 2020
+44 203 973 8810