Spinal manual therapy versus nerve root injection for patients with back-related leg pain
| ISRCTN | ISRCTN87156139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87156139 |
- Submission date
- 25/02/2024
- Registration date
- 28/02/2024
- Last edited
- 21/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study aims to investigate two common treatments for back-related leg pain—spinal manual therapy and cortisone injections—to understand the extent to which they improve pain, function, and quality of life in patients with sciatica. This is a randomised double-placebo controlled study. This means that participants are randomly assigned (like flipping a coin) to one of two treatment groups. One group gets active or real spinal manual therapy plus placebo (i.e., inactive) nerve root injection, and the other group gets active cortisone injection plus placebo spinal manual therapy. A strength of this approach is that both groups receive active or real treatment for back-related leg pain. The inclusion of a placebo in both treatment groups is also important. It strengthens the scientific approach and quality of the study.
Who can participate?
Adult patients aged at least 18 years old with back-related leg pain symptoms
What does the study involve?
Participants are treated for up to 12 weeks during the study. Up to 12 active or placebo spinal manual therapy treatments and up to 2 active or placebo nerve root injections are provided. Participants and their chiropractors decide on the number of consultations needed. Participants receive information on the management of back-related leg pain in a brief educational patient booklet, and simple strategies for remaining active and managing their pain. Participants also receive other supportive treatments during treatment visits—soft tissue (massage-like) techniques and heat or cold—if deemed appropriate based on their needs and shared decision-making with the treating chiropractor.
While participants receive treatments as part of the study, they can continue to see their family doctor and take painkillers as needed. Similarly, if they are receiving care from an alternative or complementary healthcare provider (e.g., physiotherapist, osteopath, massage therapist, acupuncturist)—they are asked to keep these therapies to a minimum while they receive the study treatments.
What are the possible benefits and risks of participating?
Spinal manual therapy and cortisone injections can help with back-related leg pain and may directly benefit the typical symptoms. Treatments (up to 12 spinal manual therapy treatments and up to 2 nerve root injections) are provided at no cost during the 12-week treatment period. Participants in this scientific study may indirectly help future people with back-related leg pain.
The two study interventions are safe and are part of standard current healthcare for back-related leg pain in Switzerland. Yet, a possible burden of the study is the time involved in receiving an active treatment and a placebo treatment. Based on the best available evidence, potential side effects associated with spinal manual therapy and cortisone injections are minor and short-lasting. For example, people who receive spinal manual therapy may experience mild muscle soreness, which typically resolves within 1 to 2 days. Some people experience minor side effects after cortisone injections such as increased pain at the injection site, pain in other areas, and lightheadedness.
Where is the study run from?
University Spine Centre Zurich at Balgrist University Hospital (Zurich, Switzerland)
Epidemiology, Biostatistics and Prevention Institute (EBPI) at the University of Zurich
When is the study starting and how long is it expected to run for?
June 2023 to July 2027
Who is funding the study?
The Swiss National Science Foundation (SNSF) and the European Centre for Chiropractic Research Excellence (ECCRE) are funding the study.
Who is the main contact?
PD Dr. Cesar Hincapié, DC PhD, cesar.hincapie@uzh.ch
Contact information
Public, Scientific, Principal Investigator
Forchstrasse 340
Zurich
8008
Switzerland
 ORCID ID |
0000-0002-7257-8122 |
|---|---|
| Phone | +41 44 386 57 29 |
| cesar.hincapie@uzh.ch |
Study information
| Study design | 52-week multicentre two-parallel-group assessor-blinded double-sham-controlled randomized noninferiority clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, GP practice, Hospital, Other therapist office |
| Study type | Quality of life, Treatment, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Spinal manual therapy versus nerve root injection for the management of patients with lumbar radicular pain: the SALuBRITY randomised clinical trial |
| Study acronym | SALuBRITY |
| Study objectives | SALuBRITY is a noninferiority trial. The null hypothesis is that spinal manual therapy (SMT) will be inferior to nerve root injection (NRI) in reducing leg pain impact at 12-weeks after randomisation in patients with lumbar radicular pain. The alternative hypothesis is that SMT will be noninferior to NRI in reducing leg pain impact at 12-weeks after randomisation in patients with lumbar radicular pain. |
| Ethics approval(s) |
Approved 12/03/2024, Kantonale Ethikkommission Zürich (Stampfenbachstrasse 121, Zürich, 8090, Switzerland; +41 43 259 79 70; info.kek@kek.zh.ch), ref: 2023-02217 |
| Health condition(s) or problem(s) studied | Lumbar radicular pain |
| Intervention | This study is a 52-week multicentre, two-parallel-group, assessor-blinded, double-sham-controlled, randomised noninferiority clinical trial with an embedded vanguard (internal pilot) phase, process evaluation, cost-effectiveness analysis, and an adjunct non-randomised patient preference cohort, to compare spinal manual therapy versus corticosteroid nerve root injection for the management of patients with lumbar radicular pain. A central, web-based, stratified randomisation method is in the randomised controlled trial: 1. Active spinal manual therapy (SMT) plus sham-control nerve root injection (NRI). Active SMT is a pragmatic therapeutic concept combining lumbar spine mobilisation and manipulation, as clinically indicated given patient presentation, clinician assessment, treatment tolerance, and shared decision-making between the patient and chiropractor. Sham-control NRI involves deep intramuscular dry needling without therapeutic intent, 2 cm proximal to the usual active periradicular injection location. 2. Active corticosteroid NRI plus sham-control SMT. Active corticosteroid NRI involves periradicular injection of 1 ml of (4 mg) dexamethasone dihydrogenphosphate (non-particulate corticosteroid), with 1 ml of 0.2% ropivacaine. Sham-control SMT involves the application of manual manoeuvres mimicking spinal manual therapy without therapeutic intent; operationalised as the application of a high-velocity, low-amplitude thrust to the gluteal region, small oscillations of the lumbar spine flexion-distraction piece with contact on sacrum, and downward scapular thrusts, all without therapeutic intent. Adjunct patient preference cohort (only for consenting participants that meet trial eligibility criteria but decline randomisation or participation in the RCT, with a strong preference for one of the active trial interventions or usual care): 3. Patient preference observational cohort arm interventions: a) active SMT; b) active corticosteroid NRI; c) usual care (i.e., any treatment recommended or offered by the healthcare professionals the patient would normally choose to see in the community). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Leg pain impact measured using the pain intensity, enjoyment of life, and general activity (PEG) scale (0 to 10) at baseline, 4, 8, 12, 26, and 52 weeks. The primary endpoint is leg pain impact assessed at 12 weeks after randomisation. |
| Secondary outcome measures | 1. Overall back and leg pain impact is measured using the PEG scale at baseline, 4, 8, 12, 26, and 52 weeks. 2. Time to resolution of sciatica symptoms measured on a 6-point ordered categorical scale. Data will be collected by weekly SMS text messages for the first 3 months, then from months 4 to 12 the SMS data collection will change to monthly, or until patients report on two consecutive occasions that they have recovered. 3. Prognostic risk status as measured by the STarT Back (low/medium/high risk of poor outcome) at baseline, 12, 26, and 52 weeks. 4. Back pain disability/function as measured by the Oswestry Disability Index (ODI, 0 to 100) at baseline, 4, 8, 12, 26, and 52 weeks. 5. Sciatica symptoms as measured by the Sciatica Bothersomeness Index (SBI, 0 to 24) at baseline, 4, 8, 12, 26, and 52 weeks. 6. Sleep problems as measured by the Jenkins Sleep Scale (JSS-4, 0 to 20) at baseline, 4, 8, 12, 26, and 52 weeks. 7. Fear of movement as measured by the Tampa Scale for Kinesiophobia (TSK-11, 11 to 44) at baseline, 4, 8, 12, 26, and 52 weeks. 8. Pain catastrophizing as measured by the Pain Catastrophizing Scale (PCS-6, 0 to 24) at baseline, 4, 8, 12, 26, and 52 weeks. 9. Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS, 0 to 42) at baseline, 4, 8, 12, 26, and 52 weeks. 10. Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ-4, 4 to 24) at baseline, 4, 8, 12, 26, and 52 weeks. 11. Consultation-based reassurance as measured by the Consultation Reassurance Questionnaire (CRQ-12, 0 to 54) at baseline, 4, 8, and 12 weeks. 12. Therapeutic alliance as measured by the Working Alliance Inventory - short revised (WAI-SR, 12 to 60) at 4 weeks. 13. General health as measured by a self-rated general health item from the WHO 5-point ordinal scale at baseline, 4, 8, 12, 26, and 52 weeks. 14. Health-related quality of life as measured by the utility-based quality of life (EQ-5D-5L) at baseline, 4, 8, 12, 26, and 52 weeks. 15. Treatment expectations as measured by the Expectation for Treatment Scale (ETS, 5 to 20) at baseline. 16. Adverse events as measured by clinician reports and patient surveys at 4, 8, 12, 26, and 52 weeks. 17. Global perceived change as measured by the Patient Global Impression of Change (PGIC, 7-point) at 4, 8, 12, 26, and 52 weeks. 18. Patient satisfaction with care and with the results of care as measured by 5-point patient satisfaction scales at 4, 8, 12, 26, and 52 weeks. 19. Participant blinding success as measured by the Bang blinding index (BI) and James BI after first SMT and NRI intervention sessions and at 12 weeks. 20. Performance at work as measured by a single item (NRS, 0 to 10) at baseline, 4, 8, 12, 26, and 52 weeks. 21. Missed work as measured by capturing the number of days missed from work at baseline, 4, 8, 12, 26, and 52 weeks. 22. Healthcare utilisation as measured by capturing resource utilisation and medication use at baseline, 4, 8, 12, 26, and 52 weeks. |
| Overall study start date | 01/06/2023 |
| Completion date | 31/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 280 (randomised trial) |
| Key inclusion criteria | Current participant inclusion criteria as of 20/06/2024: A patient will be eligible to participate in the trial if the following criteria are satisfied: 1. Aged 18 years of age and older 2. Consulting in general practice, telemedicine call centre, outpatient spine clinic, ED, or self-assesses with back or leg pain symptoms, and lumbosacral radicular pain or sciatica is suspected 3. At least moderate leg pain severity (≥3 out of 10 on NRS) 4. A lumbar spine MRI assessment available from the past 12 months 5. Following standard clinical assessment, the diagnosis of radicular pain caused by disc herniation (RAPIDH) is confirmed by a chiropractor - RAPIDH criteria score of ≥9 out of 20 (simplified weighted score of clinical signs and symptoms predicting RAPIDH: patient-reported unilateral leg pain [3 points], monoradicular leg pain [6 points], positive straight leg raise (SLR) ≤60° (SLR is positive if typical leg pain is produced between 0° and 60°) or positive femoral nerve stretch test [4 points], unilateral muscle weakness [3 points], unilateral ankle or patellar reflex decrease [4 points]; sensitivity 95%, specificity 71%) 6. Can read and communicate in German or English 7. An active email address and internet access via a mobile phone or computer Previous participant inclusion criteria: A patient is eligible to participate in the trial if the following criteria are satisfied: 1. Aged 18 years old and over 2. Consulting in general practice, telemedicine call centre, outpatient spine clinic, emergency department, or self-assesses with back or leg pain symptoms and lumbar radicular pain is suspected 3. At least moderate leg pain severity (≥3 out of 10 on NRS) 4. A lumbar spine MRI assessment available in the past 6 months 5. After a standard clinical assessment, the diagnosis of radicular pain caused by disc herniation (RAPIDH) is confirmed by a chiropractor - RAPIDH criteria score of ≥9 out of 20 (a simplified weighted score of clinical signs and symptoms predicting RAPIDH: unilateral patient-reported pain in legs [3 points], monoradicular leg pain [6 points], positive straight leg raise (SLR) ≤60° (SLR is positive if typical leg pain is produced between 0° and 60°) or positive femoral nerve stretch test [4 points], unilateral muscle weakness [3 points], unilateral ankle or patellar reflex decrease [4 points]; sensitivity 95%, specificity 71%) 6. Can read and communicate in German or English 7. An active email address and internet access via mobile phone or computer |
| Key exclusion criteria | Current participant exclusion criteria as of 20/06/2024: A patient will not be eligible to participate in the trial if any of the following criteria apply: 1. Suspected serious spinal pathology or ‘red flags’ (e.g., cauda equina syndrome, progressive or widespread neurological deficit, spinal cord compression, suspicion of malignancy, infection, fracture, inflammatory spondyloarthropathy) 2. A history of lumbar spine surgery 3. A history of corticosteroid injection for sciatica symptoms in the past 4 weeks 4. Currently receiving ongoing care from a chiropractor for the same problem 5. Serious comorbidity preventing them from attending a research clinic or being able to undergo assessments and interventions 6. Pregnant or breastfeeding, or suspicion of pregnancy 7. A contraindication for spinal manual therapy (congenital spine anomalies, spinal infection, spinal tumour, spinal fracture) 8. A contraindication for corticosteroid nerve root injection (allergy to contrast medium, severe diabetes, oral anticoagulation that cannot be paused) 9. Already taking part in another research study related to back and/or leg pain Previous participant exclusion criteria: A patient is not eligible to participate in the trial if any of the following criteria apply: 1. Suspected serious spinal pathology or ‘red flags’ (e.g., cauda equina syndrome, progressive or widespread neurological deficit, spinal cord compression, suspicion of malignancy, infection, fracture, inflammatory spondyloarthropathy) 2. A history of lumbar spine surgery 3. Currently receiving ongoing care from a chiropractor for the same problem 4. Serious comorbidity preventing them from attending a research clinic or being able to undergo assessments and interventions 5. Pregnancy or breastfeeding, or suspicion of pregnancy 6. A contraindication for spinal manual therapy (congenital spine anomalies, spinal infection, spinal tumour, spinal fracture) 7. A contraindication for corticosteroid nerve root injection (allergy to contrast medium, severe diabetes, oral anticoagulation that cannot be paused) 8. Is already taking part in another research study related to back and/or leg pain |
| Date of first enrolment | 29/04/2024 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Zurich
8008
Switzerland
Zurich
8001
Switzerland
Sponsor information
Hospital/treatment centre
Forchstrasse 340
Zurich
8008
Switzerland
| Phone | +41 044 386 11 11 |
|---|---|
| info@balgrist.ch | |
| Website | https://www.balgrist.ch/ |
"ROR" |
https://ror.org/02yzaka98 |
Funders
Funder type
Not defined
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Private sector organisation / International organizations
- Alternative name(s)
- Kiropraktorernes Videnscenter Syddansk Universitet, The European Centre for Chiropractic Research Excellence, ECCRE
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon reasonable request from the Sponsor-Investigator. Requests should be emailed to cesar.hincapie@uzh.ch. An external data request process will be initiated and considered, when pertinent. Swiss law on health research (Human Research Act [HRA, RS 810.30]) and strict Swiss data protection laws apply. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | PPI project | 17/01/2024 | 28/02/2024 | Yes | No |
| Other publications | SALuBRITY blinding feasibility randomised controlled trial protocol | 02/05/2024 | 04/06/2024 | Yes | No |
| Other publications | Data from the blinding feasibility trial informing the blinding methods | 14/01/2025 | 21/01/2025 | Yes | No |
Editorial Notes
21/01/2025: Publication reference added.
23/08/2024: The recruitment start date was changed from 02/04/2024 to 29/04/2024.
20/06/2024: The participant inclusion and exclusion criteria were changed.
04/06/2024: Publication reference added.
09/04/2024: The recruitment start date was changed from 01/04/2024 to 02/04/2024.
13/03/2024: Ethics approval was added.
26/02/2024: Study's existence confirmed by the Cantonal Ethics Commission.
