Sciatica Musculoskeletal Diseases Sciatica
Conditions
Interventions
All participants will be randomised to receive two doses of subcutaneous injection two weeks apart. The intervention group will receive 80 mg adalimumab followed by 40 mg in order to administer a the
Sponsors
Bangor University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age and older 2. Clinical features of sciatica 3. Leg pain worse or as bad as back pain, obtained by asking the participant 4. Unilateral leg pain approximating a dermatomal distribution (contralateral buttock pain permitted if it does not extend below the inferior gluteal margin) obtained by asking the participant 5. One of the following: 5.1. Positive neural tension test such as straight leg raise test (SLR) restricted <50 degrees by leg pain; positive femoral stretch test 5.2. Muscle weakness or loss of tendon reflex affecting one myotome 5.3. Loss of sensation in a dermatomal distribution 6. Persistent symptoms for at least 4 weeks and less than 6 months despite first-line treatment in primary care; obtained by asking the participant 7. Moderate to high severity (=30) on Oswestry Disability Index 8. Female partners of sexually active men should use adequate contraceptives for at least five months after the last injection. Female patients should have a negative urine pregnancy test within 2 weeks prior to randomisation, unless they are post-menopausal or have had a sterilisation operation. Sexually active men must also use adequate contraceptive methods
Exclusion criteria
Exclusion criteria: 1. Symptoms persisting for longer than 6 months obtained by asking the participant 2. A previous episode of sciatica in the last 6 months 3. Unable to perform MRI (e.g., magnetic metal implants, potential metallic intra-ocular foreign bodies, claustrophobia, extreme obesity) obtained from the medical records and by asking the participant 4. Serious spinal pathology, including cauda equina syndrome, malignancy, recent fracture, infection or very large disc prolapse which might require an urgent spinal surgery opinion, identified from participants' previous medical history in their medical records or from magnetic resonance imaging (MRI) 5. Incidental serious pathology identified by MRI (e.g., adrenal tumour) 6. Neurological deficit involving muscle weakness requiring an urgent spinal surgery assessment e.g. foot drop 7. Widespread pain throughout the body including the upper limb (pain is considered widespread when all of the following are present: pain in the left side of the body, pain in the right side of the body, pain above the waist, and pain below the waist. In addition, axial skeletal pain [cervical spine or anterior chest or thoracic spine or low back] must be present) 8. Prior use of biological agents targeting TNF-alpha within the previous 6 months obtained from the medical records and by asking participant 9. Previous lumbar spinal surgery obtained from the medical records and by asking the participant 10. Contra-indications to adalimumab injection including serious infection such as active or latent tuberculosis, transplanted organ, demyelinating disorders, malignancy, cardiac failure, low white cell count, pregnancy obtained from the medical records, results of investigations and by asking the participant 11. Pregnant or breastfeeding (women must not breastfeed for at least 5 months after the last adalimumab injection) 12. Unable to communicate in English or Welsh; unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical outcome will be back pain specific disability using the Oswestry Disability Index measured at 12 months. The primary economic outcomes will be the incremental cost per QALY gained, estimated by administering the EQ-5D-5L at each follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other outcomes will measure: physical function, generic health status, health utility, fear avoidance beliefs, self-efficacy, anxiety & depression, employment status, use of health and personal social care services, adverse events. Secondary continuous outcome variables will be assessed in a similar way to the primary outcome variable, with the exception of time to referral for surgery, which will be assessed from trial entry using Kaplan-Meier survival analyses and the log rank test. Dichotomous variables will be explored using logistic regression. These analyses will be repeated using pre-specified participant subgroups (including the presence of neurological deficit on entry to the trial and MRI findings). An exploratory analysis will trial the association between the clinical symptoms and MRI findings will be assessed by two independent radiologists who will interpret the proximity of the affected nerve root and the disc bulge or extrusion, and the probability that the nerve root is irritated by other pathology such as spondylosis. The level of agreement between the radiologists will be demonstrated using the kappa statistic. Clinical and MRI findings will be included in analyses of treatment response and treatment interactions. | — |
Countries
United Kingdom
Contacts
Public ContactAlison Jenkins
Outcome results
None listed