A randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

Phase 1

• Conditions: Sciatica is a symptom defined as unilateral, well-localised leg pain, with a sharp, shooting or burning quality, that approximates to the dermatomal distribution of the sciatic nerve down the posterior lateral aspect of the leg, and normally radiates to the foot or ankle. It is often associated with numbness or paraesthesia in the same distribution; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000636-15-GB
• Lead Sponsor: Bangor University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-17
• Study Completion: 2016-09-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

• 18 years of age and older;
• Clinical features of sciatica
• Leg pain worse or as bad as back pain, obtained by asking the participant
• 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
• And one of the following:
o Positive neural tension test such as Straight leg raise test (SLR) restricted <50 degrees by leg pain; positive femoral stretch test, loss of sensation in a dermatomal distribution
o Muscle weakness or loss of tendon reflex affecting one myotome
• Persistent symptoms for at least 4 weeks and less than six months
Persistent symptoms for at least 4 weeks and less than six months despite first line treatment in primary care; obtained by asking the participant
• Moderate to high severity (=30) on Oswestry Disability Index.
• 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 two weeks prior to randomisation, unless they are postmenopausal or have had a sterilisation operation. Sexually active men must also use adequate contraceptive methods.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 82

Exclusion Criteria

• Symptoms persisting for longer than six months obtained by asking the participant;
• A previous episode of sciatica in the last six months
• Unable to perform MRI (e.g. magnetic metal implants, potential metallic intraocular
foreign bodies, claustrophobia, extreme obesity) obtained from the medical records and by asking the participant
• 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)
• Incidental serious pathology identified by MRI (e.g. adrenal tumour)
• Neurological deficit involving muscle weakness requiring an urgent spinal surgery assessment e.g. foot drop
• 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).
• Prior use of biological agents targeting TNF alpha within the previous six months obtained from the medical records and by asking participant;
• Previous lumbar spinal surgery obtained from the medical records and by asking the participant;
• Contraindications 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;
• Pregnant or breastfeeding (women must not breastfeed for at least five months after the last adalimumab injection.
• Unable to communicate in English or Welsh; unable or unwilling to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified