Manual spinal therapy versus nerve root injection for lumbosacral radicular pain: the randomized clinical study SALuBRITY

Identifiant de l'essai ICTRP
ISRCTN87156139 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
non disponible

Titre académique
Spinal manual therapy versus nerve root injection for the management of patients with lumbar radicular pain: the SALuBRITY randomised clinical trial (ICTRP)

Titre public
Spinal manual therapy versus nerve root injection for patients with back-related leg pain (ICTRP)

Maladie en cours d'investigation
Lumbar radicular pain
Musculoskeletal Diseases (ICTRP)

Intervention étudiée
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 s (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
52-week multicentre two-parallel-group assessor-blinded double-sham-controlled randomized noninferiority clinical trial (Quality of life, Treatment, Safety) (ICTRP)

Critères d'inclusion/exclusion
Gender: Both
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
(ICTRP)

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

Critères d'évaluation principaux et secondaires
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. (ICTRP)

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. (ICTRP)

Date d'enregistrement
28.02.2024 (ICTRP)

Inclusion du premier participant
29.04.2024 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
Cesar Hincapi?, cesar.hincapie@uzh.ch, +41 44 386 57 29 (ICTRP)

ID secondaires
Nil known, Nil known, Nil known (ICTRP)

Résultats-Données individuelles des participants
YesAvailable on request. 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. (ICTRP)

Informations complémentaires sur l'essai
https://www.isrctn.com/ISRCTN87156139 (ICTRP)