Condition category
Musculoskeletal Diseases
Date applied
21/11/2013
Date assigned
03/01/2014
Last edited
03/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lumbar facet-joints are small, paired joints in the low back that provide stability, integrity and flexibility of movement to the spine. Diseased facet-joints may lead to persistent low back pain. A number of treatment options are available to treat lumbar facet-joint pain, with the aim of restoring function and achieving a good quality of life. These include medication, physical therapy, injection of therapeutic substances into the back (such as facet-joint injections), and surgery. However, at present, there is insufficient high-quality evidence to support the use of lumbar facet-joint injection for non-specific low back pain of less than 12 months’ duration, and hence The National Institute of Health and Clinical Excellence (NICE) did not approve their use in their 2009 publication to cover the early treatment and management of persistent low back pain.

Who can participate?
Patients aged 18 to 70 years with low back pain of greater than three months’ duration.

What does the study involve?
Patients will receive diagnostic injections (medial branch nerve blocks); those with a positive response will be randomly allocated to receive either facet-joint injections or a sham procedure. The patients will then receive a combined physical and psychological programme, involving a cognitive behavioural approach and exercise. This has been recommended by NICE as a strategy to reduce pain and its impact on the person’s day -to-day life, even if the pain cannot be cured completely.

What are the possible benefits and risks of participating?
If successful this study will demonstrate that we are able to standardise the methods for facet-joint injection and sham procedure, and that the proposed study design is deemed acceptable by patients and clinicians. There are no obvious risks to participating, although there can be procedure-related side effects. These include flare up, pain at the site of injection, and redness in the area.

Where is the study run from?
The study will be conducted in three hospital-based pain medicine centres: Barts Health NHS Trust (until April 2012, Barts and The London NHS Trust), Basildon and Thurrock University Hospitals NHS Foundation Trust, and The Walton Centre NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
We expect to start the study in April 2014 and we anticipate that the project will take a total of 21 months to complete.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Professor Richard Langford
richard.langford@me.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Langford

ORCID ID

Contact details

Consultant in Anaesthesia and Pain Medicine Anaesthesia and Critical Care
Barts and the London NHS Trust/Queen Mary College
University of London
St Bartholomew’s Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
richard.langford@me.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PARC_HTA_11/31/02

Study information

Scientific title

A multicentre double-blind randomised controlled trial to assess the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back pain: a feasibility study

Acronym

Study hypothesis

The aim of this study is to assess the feasibility of conducting a definitive trial to evaluate the clinical- and cost-effectiveness of facet-joint injections (FJIs) compared to a sham procedure, in patients with non-specific low back pain of more than three months’ duration.

Ethics approval

The study will be reviewed by a Research Ethics Committee, to ensure that the rights, safety, dignity and well-being of study participants are protected. A copy of the proposed informed consent form will be reviewed with the study protocol. The NETSCC will be informed once a specific NRES committee has been appointed. We will apply for ethical review through the centralised National Research Ethics Service (NRES) system and commence work on the application on approval of an agreed protocol and agreement to fund the study.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Low back pain

Intervention

Patients will be recruited from pain clinics at the three participating NHS centres and their associated community-based pain clinics. Patients will be referred by their general practitioners with low back pain requiring further specialist assessment, for reasons such as uncertain diagnosis, failure of conservative treatment or expectation of therapeutic interventions. We will recruit a total of 150 patients, of whom 60 (40%) are expected to have a positive diagnostic test for facet-joint disease, and these 60 patients will be randomly and equally allocated to receive one of the following two interventions:

1. Facet-joint injections of local anaesthetic and steroid plus a combined physiotherapy and psychology (CPP) programme
2. A sham (placebo) procedure plus a CPP programme

FJIs, the sham procedures and diagnostic tests will be performed in day surgery units at each of the three main centres. They will be carried out only by appropriately qualified members of the research team (Fellows of the Faculty of Pain Medicine of the Royal College of Anaesthetists), adhering to strict aseptic conditions and following local theatre protocols with regards to admission and discharge criteria.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess the eligibility criteria, recruitment and retention of patients in the two treatment arms (FJI versus sham procedure)

Secondary outcome measures

1. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams
2. To assess the feasibility of the proposed definitive trial design including:
2.1. Testing of randomisation and blinding procedures
2.2. Development of an appropriate active and sham procedure for FJIs
2.3. Assessment of the consistency of the trial sites to deliver the combined physical and psychological programme
2.4. Ability to collect the outcomes proposed for the main trial (pain, functioning, health-related quality of life, anxiety and depression, healthcare resource utilisation, complications and adverse events)
3. To estimate outcome standard deviation to inform the power calculation for a definitive trial
4. To finalise the protocol design, statistical plan, number of centres required and study duration of the definitive trial

Overall trial start date

01/04/2014

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of nonspecific low back pain
2. Low back pain of greater than three months’ duration
3. Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment
4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels
5. At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture and manual therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Patient refusal
2. More than four painful lumbar facet-joints
3. Patient has not completed at least two components of NICE-recommended best non-invasive care
4. ‘Red flag’ signs
5. Hypersensitivity to study medications or X-ray contrast medium
6. Radicular pain
7. Dominantly midline tenderness over the lumbar spine
8. Any other dominant pain
9. Any major systemic disease or mental health illness that may affect the patient’s pain, disability and/or their ability to exercise and rehabilitate
10. Any active neoplastic disease, including primary or secondary neoplasm
11. Pregnant or breastfeeding patients
12. Previous lumbar facet-joint injections
13. Previous lumbar spinal surgery
14. Patients with morbid obesity (body mass index of 35 or greater)
15. Major trauma or infection to the lumbar spine
16. Participation in another clinical trial in the past 30 days
17. Patients unable to commit to the six-month study duration
18. Patients involved in legal actions or employment tribunals related to their low back pain
19. Patients with a history of substance abuse

Recruitment start date

01/04/2014

Recruitment end date

31/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant in Anaesthesia and Pain Medicine Anaesthesia and Critical Care
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

NIHR Health Technology Assessment Programme - HTA (UK)

Sponsor details

Evaluation Trials and Study Coordinating Centre
University of Southampton
Alpha House
Enterprise Road
Southampton
SO16 7NS
United Kingdom
+44 (0)2380594417
s.bevan@southampton.ac.uk

Sponsor type

Government

Website

http://www.nets.nihr.ac.uk/programmes/hta

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK), ref: 11-31-02

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