Facet-joint injections for people with persistent non-specific low back pain
| ISRCTN | ISRCTN93184143 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93184143 |
| EudraCT/CTIS number | 2014-000682-50 |
| Secondary identifying numbers | HTA 11/31/01, REGO-2013-592 |
- Submission date
- 14/02/2014
- Registration date
- 27/02/2014
- Last edited
- 29/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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?
Participants are randomly allocated to receive either facet joint injections and 'best usual care' physiotherapy treatment, or 'best usual care' physiotherapy treatment only. Participants are 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 is 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?
November 2014 to 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
Contact information
Scientific
Warwick Clinical Trials Unit
University of Warwick
Gibbett Hill
Coventry
CV4 7AL
United Kingdom
Study information
| Study design | Mixed-methods randomised multicentre feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact FIS@warwick.ac.uk to request patient information sheet |
| 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 |
| Study acronym | FIS |
| Study objectives | 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. |
| Ethics approval(s) | NRES Committee Yorkshire & The Humber - Sheffield, 20/08/2014, ref: 14/YH/0161 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2014 |
| Completion date | 01/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 01/04/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CV4 7AL
United Kingdom
Sponsor information
Hospital/treatment centre
University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
"ROR" |
https://ror.org/025n38288 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
29/06/2017: Publication reference added.
