FORENSIC-UK: Fusion versus Best Conservative Care
| ISRCTN | ISRCTN74906087 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74906087 |
| IRAS number | 343826 |
| Secondary identifying numbers | CPMS 66893, Grant Code: NIHR134859 |
- Submission date
- 27/03/2025
- Registration date
- 04/04/2025
- Last edited
- 04/04/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Low back pain is common for many people and often improves without specific treatment. However, for some people their low back pain does not go away, and the use of painkillers and physiotherapy (which we call non-surgical treatment) is often successful as the first line of treatment. There has also been good research to show that this treatment is beneficial. However, this approach does not work for everyone, and some people are left with ongoing severe low back pain impacting their health, daily activities and work. Some medical professionals think that an operation called spinal fusion may help. The study aims to investigate whether treating low back pain with surgery is better than using non-surgical treatment for patients with long-standing back pain that has not responded to previous non-surgery treatment, and also whether the spinal fusion surgery is good value for money for the NHS.
Who can participate?
Participants can join the study if they:
1. Have severe and ongoing low back pain for 6 months or more
2. Have had some non-surgical care to help with back pain in the past 6 months or more, which has been unsuccessful
3. Are aged between 18 and 65 years
4. Suitable to receive either spinal fusion surgery or the best conservative care
What does the study involve?
Participants will be randomly allocated to either Spinal Fusion Surgery or personalised Best Conservative Care.
Spinal Fusion Surgery: this group will receive Spinal Fusion Surgery, an operation to surgically fix the spinal bones together in their lower back.
Best Conservative Care: this group will undergo a personalised non-surgical treatment plan which will be specially created for the patient using a shared decision-making tool between the treating clinician and the participant. It can include checking and maybe adjusting the participants' current medication, exercise, self-management, pain control, and signposting to other NHS services. Participants will be asked to complete questionnaires relating to their treatment, pain and quality of life at 6,12 and 24 months. Participants will be able to complete questionnaires electronically or on paper according to their preference.
What are the possible benefits and risks of participating?
The benefits of taking part are that participants' back pain may improve, and that physiotherapy or pain relief may no longer be required following either spinal fusion surgery or best conservative care.
For all participants, the risks are that the pain may not improve and the side effects of medication. Also, there is exposure to a low-level magnetic field if you have an MRI scan, or low-level radiation due to the CT/SPECT scan, to check if you are suitable for this study. For those receiving surgery, there are the risks associated with any operation (e.g. bleeding from the wound site) and general anaesthetic (e.g. nausea, headache), and exposure to low-level radiation due to the CT scan at 2 years post-surgery. For those receiving best conservative care, there is a risk of increased pain associated with exercise. All procedures used in this study are known in the NHS and deemed safe.
Where is the study run from?
The study is managed by the Surgical Intervention Trials Unit (SITU), Oxford Clinical Trials Research Unit (OCTRU), University of Oxford (UK). The study is sponsored by the University of Oxford
When is the study starting and how long is it expected to run for?
October 2024 to September 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
Prof. David Beard, david.beard@ndorms.ox.ac.uk
Contact information
NDORMS
University of Oxford
Botnar Research Centre
Windmill Rd
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0009-0005-2222-734X |
|---|---|
| Phone | +44 (0)7500 072555 |
| odette.dawkins@ndorms.ox.ac.uk |
Principal Investigator
NDORMS
University of Oxford
Botnar Research Centre
Windmill Rd
Oxford
OX3 7LD
United Kingdom
| ORCID ID |
0000-0001-7884-6389 |
|---|---|
| Phone | +44 (0)1865 737 929 |
| david.beard@ndorms.ox.ac.uk |
Principal Investigator
Cardiff and Vale University Health Board
Cardiff
CF14 4XW
United Kingdom
| ORCID ID |
0000-0001-8676-6100 |
|---|---|
| sashin.ahuja@wales.nhs.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Education or Self-Management, Imaging, Physical, Surgery, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 47092_PIS_V2.0_12Mar25.pdf |
| Scientific title | FORENSIC-UK: The clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain |
| Study acronym | FORENSIC-UK |
| Study hypothesis | The aim of FORENSIC-UK is to test for superiority of lumbar fusion surgery (LFS) versus continued best conservative care (BCC) (non-surgical) on disability (physical function) in patients with severe persistent low back pain and lumbar degenerative disease, and to investigate the cost-effectiveness of LFS compared with continued BCC. |
| Ethics approval(s) | Approved 19/03/2025, East of England - Cambridge East Research Ethics Committee (2 Redman Place, London, EC20 1JQ, UK; +44 (0)20 7104 8096; CambridgeEast.REC@hra.nhs.uk), ref: 25/EE/0040 |
| Condition | Low back pain |
| Intervention | The design of the study is a randomised controlled trial with a recruitment target of 270 patients who have had and still have persistent LBP for 6 months or more. (It is crucial for this study that patients have tried the current recommended conservative non-surgery standard NHS treatments before they are considered for spinal fusion surgery, thereby reserving LFS for patients who have not had a good response from their previous conservative care.) Following consent the patients would be randomised in a ratio of 1:1, thus giving 135 participants to each arm of the study (lumbar fusion surgery [LFS] versus continued best conservative care [BCC]). Participants will not be blinded in this study due to the nature of a non-surgery arm and surgery arm. Participants allocated to best conservative care will have individual “tailoring” of their care (to make it the very best possible). Over a 24-month period we will ask patients about their physical function, pain, mental health, general health, quality of life, days off work, intervention adherence and healthcare use. We will ask measured, validated and carefully designed sets of questionnaires that will include: Low Back Pain intensity using the Numerical Rating Scale(NRS) sent to participants monthly via SMS text messaging, email or by post in a paper form. Paper or electronic links (participant preference) to Questionnaires at the beginning(Baseline), 6, 12 and 24 months will be sent to each participant and will include: the Oswestry Disability Index (ODI) which will measure our Primary Outcome, quality of life (EQ-5D-5L), Depression (PHQ8), Fear Avoidance Beliefs (TSK), Self-efficacy Beliefs (PSEQ), Global Perceived Effect (GPE) work outcomes (days-off-work), Heath-care Resource Use and treatment satisfaction (only at 24m). Any adverse events, revision/further surgery, fusion failure rate, healthcare use (NHS and non-NHS), including surgery, conservative care, and concurrent treatments (including analgesia) will be collected via clinical forms. We have built into the study an internal pilot stage to recruit 45 participants in the first 10 months over 8-10 sites to test the recruitment and retention process of the study. We are using a Stop/Go assessment at the end of the Pilot phase to assess the feasibility of the study. In addition to this we have integrated a QRI Information study with the University of Bristol using a two-phase assessment: Phase 1 to assist in the design and development of the study, and Phase 2 to assist in the delivery and (if required) aid recruitment to the study. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Low back pain (LBP) related physical function is measured using the Oswestry Disability Index (ODI) at 24 months |
| Secondary outcome measures | 1. Low back pain (LBP) intensity is measured monthly using the Numerical Rating Scale (NRS on a scale 1-10) 2. Low back pain (LBP) related physical function is also measured using the Oswestry Disability Index (ODI) at baseline, 6 and 12 months 3. Cost-effectiveness will be measured with: 3.1. Quality of Life using the EQ-5D-5L at baseline, 6, 12 and 24 months 3.2. Pain Self-efficacy Questionnaire (PSEQ) at baseline, 6, 12 and 24 months 3.3. Patient Health Questionnaire (PHQ-8) at baseline, 6, 12 and 24 months 3.4. Tampa Scale of Kinesiophobia (TSK) at baseline, 6, 12 and 24 months 3.5. Global Perceived Effect Scale (GPE) at baseline, 6, 12 and 24 months 3.6. Healthcare Resources Use at baseline, 6, 12 and 24 months 3.7. Work status at baseline, 6, 12 and 24 months 3.8. Treatment Satisfaction at 24 months |
| Overall study start date | 01/10/2024 |
| Overall study end date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 270; UK Sample Size: 270 |
| Participant inclusion criteria | 1. Aged 18 to 65 years 2. Episode of Low Back Pain (lasting >=6 months) 3. Low Back Pain is >=6 on a 0-10 Numerical Rating Score (NRS) 4. Have undergone previous non-surgery treatment that aligns with best practice guidelines (National Institute of Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management (Clinical Guideline [NG59]) London 2016. Sect. 1.9), e.g.: 4.1. A course of physical therapy 4.2. A course of psychological therapy 4.3. A course of treatment from a multi-disciplinary team 4.4. A course of treatment from specialist medical care 4.5. Medial branch blocks/radiofrequency denervation 4.6. Analgesia 5. Willing and able to provide informed consent 6. Recent evidence (within the last 12 months) of lumbar degenerative disease using appropriate imaging (Magnetic Resonance Imaging [MRI] +/- Single Photon Emission Computed Tomography/Computed Tomography [SPECT/CT), +/- previous discectomy/decompression 7. Suitable for both lumbar fusion surgery (LFS) at 1 or 2 lumbar spine levels and best conservative care (BCC) |
| Participant exclusion criteria | 1. Has low-back related leg pain more severe than low back pain, e.g. claudication 2. Pain in any other body region more severe than low back pain 3. Previous (or attempted) LFS 4. Has psychiatric disorders (e.g. diagnosed personality disorders, post-traumatic stress disorder, drug or alcohol abuse/addiction, diagnosis of severe depression). 5. Radiculopathy or claudication or clinical signs of nerve decompression where the treatment plan includes offering a direct or indirect decompression along with the fusion 6. Any other reasons indicated for lumbar fusion surgery (LFS), e.g. deformity, infection, tumours, instability (due to spondylolisthesis of grade 2 or above), spinal fracture, systematic inflammatory disease |
| Recruitment start date | 01/05/2025 |
| Recruitment end date | 30/09/2026 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
- Wales
Study participating centres
Herries Road
Sheffield
S5 7AU
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Queens Square
London
WC1N 3BG
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
London Road
Bracknell
RG12 2UT
United Kingdom
Magdala Avenue
London
N19 5NF
United Kingdom
Cramlington
Northumberland
NE23 6NZ
United Kingdom
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Swansea
SA6 6NL
United Kingdom
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
University Offices
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865616494 |
|---|---|
| rgea.sponsor@admin.ox.ac.uk | |
| Website | https://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The findings will be published in a high-impact peer-reviewed journal and will be disseminated across the clinical community and NICE. Study papers will be published in high-impact factor journals and will be made available under open access so that high visibility of the work can be maintained as per the NIHR policy. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 12/03/2025 | 03/04/2025 | No | Yes |
| Protocol file | version 2.0 | 14/03/2025 | 03/04/2025 | No | No |
Additional files
Editorial Notes
27/03/2025: Study's existence confirmed by the NIHR.
