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A cluster randomised phsysiotherapy pilot study investigating the effect of using decision aid on available treatment options for patients with non specific chronic low back pain and their decision making process, on the patient's satisfaction levels

Aim of the Project

The overall aim of this project is to develop and test a Decision Support Package (DSP) to help patients seeking care for back pain to make better, more informed choices, about their treatment.

In this pilot study, we will:

  1. Develop an understanding of the factors which inform choice and decision making
  2. Use this information to develop a manual and training package, to help health professionals and patients with the informed shared decision-making process
  3. Test the newly designed intervention in a pilot cluster RCT to measure the effects on patient satisfaction

Study Outline

This proposal starts from the NICE Low Back Pain (LBP) guidelines which advise offering a course of manual therapy, exercise therapy, or acupuncture to patients with LBP lasting more than 6 months but less than 1 year.

They advise that choice of course of therapy should be informed by patient preferences; however, how this should be done is not stipulated.

In collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop and test a Decision Supprot Package.

The DSP will aid in informed shared decision making (ISDM); provide guidance to the therapists and assistance to patients during informed shared decision making at their consultation.The steps undertaken in developing the intervention and its delivery in the pilot study are:

  1. Exploratory work- This involves carrying out a review of the literature related to decision-making by patients during consultation with GP/Consultant in primary and secondary care; analysis of qualitative data; carrying out focus groups which will involve patient groups and finally carrying out Delphi study with ‘experts’ in the experience of LBP and a nominal group study to gain physiotherapists’ view.

    The overall aim of the exploratory work done is to inform the DSP intervention design.

  2. Design intervention-A DSP will be designed to help aid patients make better informed choices.

    This will also include a training programme for physiotherapists to improve their knowledge of the treatment options and their skills in ISDM.

  3. Pilot cluster randomised controlled trial- This will be a single centre cluster randomised controlled trial with the Coventry PCT physiotherapy service. Cluster randomisation will be by physiotherapists.

Recruitment for pilot RCT

The recruitment stage is due to start in October 2011. We will identify participants from those seeking treatment from the physiotherapy service at Coventry PCT.

* Recruitment into the IMPACT-LBP study is now closed and follow-up ongoing till November 2012 *


NIHR Research for Patient Benefit (RfPB) Programme: PB-PG-0808-17039

Ethical Approval

Coventry and Warwickshire Research Ethics Committee

Project Schedule

1st June 2010 to 31st May 2012.

Extended to March 2013

ISRCTN Registration



Chief Investigator

Prof Martin Underwood

Professor of Primary Care Research

Enquiries Contact

 Dr Shilpa Patel

Research Fellow; Study Manager

Tel : 024 761 50405

Key Links


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