SCIATIC

SCIATIC

Chief Investigator: 

Dr Nefyn Williams (Bangor)

Co-applicants:

Principal Investigator:

NIHR Prof Nadine Foster                                                                                         

Study Co-ordinator: 

Funder name / reference n^o:

HTA 12/201/02

MREC number:

15/WA/0105

EudraCT number: 

2015-000636-15

ISRCTN:

N/A

UKCRN Study portfolio:

18417

Summary of trial:

Trial Objectives:

1. To evaluate the effectiveness of subcutaneous injections of adalimumab plus physiotherapy compared with placebo injection of 0.9% Sodium Chloride plus physiotherapy for patients with sciatica who have failed first line primary care treatment.
2. To evaluate the cost-effectiveness of subcutaneous injections of adalimumab plus physiotherapy compared with placebo injection of 0.9% Sodium Chloride plus physiotherapy for patients with sciatica who have failed first line primary care treatment from a health service and personal social care perspective. 

Trial Design:

Multi-centre randomised controlled trial (RCT) of 332 participants recruited from primary care or musculoskeletal services with a concurrent economic evaluation and an internal pilot trial. 

Treatments:

All participants will be randomised to receive two doses of subcutaneous injection two weeks apart. The intervention group will receive 80mg adalimumab followed by 40mg [21] in order to administer a therapeutic dose of adalimumab for a period of four weeks. The control group will receive an equivalent volume of 0.9% Sodium Chloride as the intervention group. All participants will also have a course of physiotherapy.