Condition category
Musculoskeletal Diseases
Date applied
14/02/2014
Date assigned
27/02/2014
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Facet joint injections into the back have been widely used to treat selected people with low back pain. A facet joint injection is not a cure for the cause of low back pain, but it is used to help reduce the level of pain. Unfortunately there is currently no good evidence to show that they work. For the NHS to provide these injections we need evidence to show that they work. This study aims to assess the clinical and cost effectiveness of facet joint injections.

Who can participate?
Adult patients with at least moderately troublesome low back pain present for at least six months referred by their GP (doctor) for additional treatment of back pain because simple treatments for low back pain have not worked.

What does the study involve?
Patients will be randomly allocated to receive either facet joint injections and 'best usual care' physiotherapy treatment, or 'best usual care' physiotherapy treatment only. Patients will be followed up at 3 months via postal questionnaires. The main questionnaire packages are completed at the start of the study and 3, 6 and 12 months later. A pain severity score will be recorded daily for 35 days from seven days before first treatment session and following this weekly until the end of the study.

What are the possible benefits and risks of participating?
Facet joint injection is not a cure for the cause of low back pain, but it is used to help reduce the level of pain. All the participants will be people seeking care for back pain that is not resolving. Untreated they run the risk of developing chronic disability. Both the injection and the 'best usual care' physiotherapy treatment have the potential to improve the participant's low back pain and are treatments that they would not normally be able to access easily. The 'best usual care' physiotherapy treatment is a new programme specifically developed for this study that is focussed on improving outcome for people with pain coming from their facet joints. Although not proven to be more effective than conventional physiotherapy it is not a treatment that is available outside this study. If the injections make pain more manageable for the patient, even if only for a few weeks, then this will allow the patient to maximise the benefits of the rehabilitation programme by allowing them to regain their fitness more quickly. We cannot promise the study will help the individual patients, but the information we get from the study may help improve the future treatment of people with low back pain. Some people find the experience beneficial and interesting. There is, however, a recognised risk of adverse events from the facet joint injection and exposure to x-rays. Patients will be exposed to low-dose radiation because x-rays are used to ensure the facet joint injection is correctly located. The actual dose received varies but typically this is a similar level of radiation exposure to the UK background level over a 6-week period. There is a very small risk of harm from taking part in the 'best usual care' physiotherapy treatment programme.

Where is the study run from?
Warwick Clinical Trials Unit (UK).

When is the study starting and how long is it expected to run for?
Patient recruitment will start in November 2014 and end in April 2015. Patient follow up will complete in November 2015.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Harbinder Sandhu
FIS@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Underwood

ORCID ID

Contact details

Warwick Clinical Trials Unit
University of Warwick
Gibbett Hill
Coventry
CV4 7AL
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

2014-000682-50

ClinicalTrials.gov number

Protocol/serial number

HTA 11/31/01, REGO-2013-592

Study information

Scientific title

A mixed-methods, randomised, multicentre feasibility study to assess the clinical and cost-effectiveness of facet joint injections to best usual non-invasive care in patients with persistent non-specific low back pain

Acronym

FIS

Study hypothesis

In adult patients with suspected facet join pain contributing to persistent low back pain, adding the option of facet joint injections with local anaesthetic and corticosteroids to best usual non-invasive care available in the NHS is clinically and cost-effective.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/113101

Ethics approval

NRES Committee Yorkshire & The Humber - Sheffield, 20/08/2014, REC ref: 14/YH/0161

Study design

Mixed-methods randomised multicentre feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact FIS@warwick.ac.uk to request patient information sheet

Condition

Muscoskeletal, low back pain

Intervention

Participants will be randomised to receive either facet joint injection with best usual care, or best usual care only.

Pain outcomes will be collected immediately before and after injection (intervention only), daily for up to seven days before first physiotherapy treatment session until 28 days after randomisation (including seven days after notional injection date; all injections should take place within 21 days of randomisation), then weekly for three months post-intervention. Health utility data (EQ-5D-5L) will be collected daily for eight days around the notional injection date and then weekly from until three months after randomisation, at six and 12 months post randomisation. Other health outcomes will be collected at three months only .

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary outcome for this feasibility study is numerical rating scale for pain collected over three months following randomisation.

A package of outcome measures consistent with consensus recommendations for outcome assessment in back pain trials will be utilised. These include pain measurement, physical function, emotional function, back-related function, generic well-being, disability (social role), and satisfaction with care, patient rating of improvement and satisfaction with treatment, symptoms (pain), adverse events, participant disposition, and a modified form of the patient generated index. In this feasibility study we will assess performance of these measures and seek to reduce the questionnaire burden in the main trial.

The main questionnaire packages are completed at baseline (at study entry assessment) and follow-up (3, 6 and 12 months post randomisation). A pain severity score will be recorded daily for 35 days from seven days before first treatment session and following this weekly until the end of the study. Health utility (EQ-5D-5L) will be recorded weekly from one week prior to the first treatment session until the night before the injection appointment when we will ask participants to record it daily for eight days then weekly until the end of the study. In addition, intervention participants will record a pain severity 45-60 minutes before and after injection. Clinical data will recorded by the physiotherapists and the clinician and collected covering patients assessments, injections and involvement in the physiotherapy intervention. Note it may be necessary to increase the number of data points for the EQ-5D-5L and the pain severity score; firstly, if an injection is cancelled/rescheduled and secondly, towards the end to ensure test-retest reliability. To reduce costs and shorten time to completion of the feasibility study we will do a single cycle of postal follow-up with two postal reminders and a telephone call for primary outcomes at three months in this pilot study. In the main study we would also collect six and 12 month data. We do not anticipate any additional benefit from collection of long-term follow-up data in this pilot.

Secondary outcome measures

As a second primary outcome focused on back pain related disability we will use the Roland Morris Disability Questionnaire at three months, six and 12 months collected using a postal questionnaire

Overall trial start date

01/11/2014

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 22/09/2014:
1. The patient is willing to comply with the trial procedures and signed and dated informed consent is obtained
2. The patient is aged >18 with at least moderately troublesome low back pain present for at least six months
3. The patient reports low back pain as their predominant musculoskeletal pain
4. The patient has undergone therapist-delivered treatment for low back pain in the preceding six months prior to inclusion
5. The patient meets clinical criteria for possible facet joint pain when there is no radicular symptoms (defined as pain radiating below the knee) and no sacro-iliac joint pain elicited using a pain provocation test and increased pain unilaterally, bilaterally on lumbar para-spinal palpation, and increased low back pain on one or more of the following: extension (more than flexion), rotation, extension/side flexion, extension/rotation
6. The patient is able to manage text messaging, or an alternative means of daily data collection (paper-based diary)
7. The patient is fluent in written and spoken English

Previous inclusion criteria:
1.The patient is able and willing to comply with the trial procedures and signed and dated informed consent is obtained
2.The patient is >18 with at least moderately troublesome low back pain present for at least six months
3.The patient has undergone therapist-delivered treatment for low back pain in the preceding six months prior to inclusion
4.The patient meets clinical criteria for possible facet joint pain
5.The patient is able to manage text messaging, or an alternative means of daily data collection (paper based diary)
6.The patient is fluent in written and spoken English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Current exclusion criteria as of 22/09/2014:
1. The patient is unable to attend for randomised treatment, or other circumstances that would significantly decrease the chance of obtaining reliable data, achieving trial objectives or completing the trial and follow-up assessments or is considered unsuitable to participate in the trial by an investigator
2. The patient is unable/unwilling to undergo injections
3. The patient has used oral corticosteroids or had a corticosteroid injection in the preceding three months.
4. The patient is has an underlying serious psychiatric or psychological disorder that precludes participation in either intervention
5. The patient has previously undergone spinal injections
6. The patient is has previously undergone spinal surgery
7. The patient has a contraindication to facet joint injections; for example, a serious co-morbidity (e.g., severe COPD, poorly controlled diabetes), malignancy, infection, inflammatory disorder, or fracture; or is taking anti-coagulant medication
8. The patient has a known allergy to the constituents of the planned injections
9. The patient is pregnant, or suspected pregnancy
10. The patient was previously randomised in this trial
11. The patient is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial

Previous exclusion criteria:
1.The patient is unable to attend for randomised treatment, or other circumstances that would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study and follow up assessments or is considered unsuitable to participate in the study by an investigator.
2.The patient is unable/unwilling to undergo injections.
3.The patient has an underlying serious psychiatric or psychological disorder that precludes participation in either intervention.
4.The patient has a contraindication to facet joint injections (eg, serious co-morbidity, previous spinal surgery, or taking anti-coagulants).
5.The patient has a known allergy to the constituents of the planned injections.
6.The patient is pregnant or breast feeding.
7.The patient was previously randomised in this trial.
8.The patient is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial.

Recruitment start date

01/11/2014

Recruitment end date

01/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry & Warwickshire NHS Trust (UK)

Sponsor details

University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK), reference 11/31/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes