A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy

Affiliations

Mirad Taso, MD

• Clinician at the department of Physical medicine and rehabilitation Ullevål, and at the Neurosurgical department, Rikshospitalet, Oslo University Hospital

• Grant from Southern and Eastern Norway Regional Health Authority• PhD student at the University of Oslo

Copyrights apply

Copyrights apply

Copyrights apply

P: Adults with cervical radiculopathyI: ACDFC: Non surgical treatmentO: Pain, functionS: Randomised controlled trial

Background

• The yearly prevalence of neck pain was 48%, while 25% of women and 13% of men reported that they had neck pain weekly

• Disc protrusion is reported in 29% of 20-year old persons and in 43% of 80 year old, while facet joint degeneration is reported in 4% and 83%, respectively

Natvig B, Nessiøy I, Bruusgaard D, Rutle O: Musculoskeletal symptoms in a local community. Eur J Gen Practice 1995, 1:25-28.Hasvold T, Johnsen R: Headache and neck or shoulder pain - frequent and disabling complaints in the general population. Scand J Prim Health Care 1993, 11:219-224.Brinjikji W, Luetmer PH, Comstock B, Bresnahan BW, Chen LE, Deyo RA, Halabi S, Turner JA, Avins AL, James K et al: Systematic literature review of imaging features of spinal degeneration in asymptomatic populations. AJNR American journal of neuroradiology 2015, 36(4):811-816.

• Contrary, the yearly prevalence of cervical radiculopathy is relatively low.

• It was estimated to 83/100 000, peaking in fourth and fifth decades.

K R, WJ L, M OF, LT K: Epidemiology of cervical radiculopathy. Brain 1994, 117:325-335.

• Cervical radiculopathy is caused by disc herniation, spondylosis, or a combination of herniation and spondylosis.

• In 80% of patients the C6 or C7 roots.

K R, WJ L, M OF, LT K: Epidemiology of cervical radiculopathy. Brain 1994, 117:325-335.

• The natural course of cervical radiculopathy is difficult to outline. • Recent studies have described a favourable course at an average of 6

months with complete recovery ranging from 24 to 36 months.

Thoomes EJ, Scholten-Peeters W, Koes B, Falla D, Verhagen AP: The effectiveness of conservative treatment for patients with cervical radiculopathy: a systematic review. Clin J Pain 2013, 29(12):1073-1086.Wong JJ, Cote P, Quesnele JJ, Stern PJ, Mior SA: The course and prognostic factors of symptomatic cervical disc herniation with radiculopathy: a systematic review of the literature. Spine J 2014, 14(8):1781-1789.

• The surgical rates for cervical radiculopathy are lower in Norway compared with the United States but increased by 86.5 % from 2008 to 2014

• 2.5 times higher in counties with the highest rates compared to those with the lowest rates

Kristiansen JA, Balteskard L, Slettebo H, Nygaard OP, Lied B, Kolstad F, Solberg TK: The use of surgery for cervical degenerative disease in Norway in the period 2008-2014 : A population-based study of 6511 procedures. Acta neurochirurgica 2016, 158(5):969-974.

• The success rates of surgical interventions are reported from 80-95% • 2 systematic reviews have found no clear benefit of surgery over

nonsurgical treatment

van Middelkoop M, Rubinstein SM, Ostelo R, van Tulder MW, Peul W, Koes BW, Verhagen AP: Surgery versus conservative care for neck pain: a systematic review. Eur Spine J 2013, 22(1):87-95.Nikolaidis I, Fouyas IP, Sandercock PA, Statham PF: Surgery for cervical radiculopathy or myelopathy. The Cochrane database of systematic reviews 2010(1):CD001466.

Aims

• To evaluate the effectiveness of surgical versus non-surgical treatment • To evaluate factors that may contribute to better decision making.

• Study 1: one level disc herniation (C5/6 or C6/7)

• Study 2: one or two level spondylosis (C5/6 and/or C6/7)

• Patients with disabling radicular arm pain and MRI proven cervical disc herniation (study 1) or spondylosis (study 2) will be randomised to receive non-surgical or surgical treatment.

• The follow-up period is 1-year and the sample size is estimated to 50 in each arm in the two trials, in total 200 patients.

Hypothesis

• The effectiveness of surgery is not different from non-surgical treatment

• Measured by the change in Neck Disability Index (NDI) and arm pain (NRS) at 1-year follow-up in patients with cervical radiculopathy

Inclusion criteria

Exclusion criteria

• Patients with any previous cervical fractures or cervical spine surgery; • signs of myelopathy; • rapidly progressive paresis or paresis < grade 4; • pregnancy; • arthritis involving the cervical spine; • infection or active cancer; • generalised pain syndrome;

• serious psychiatric or somatic disease that exclude one of the treatment alternatives;

• concomitant shoulder disorders that may interfere with outcome; • abuse of medication/narcotics, • not able to understand written Norwegian, • not willing to accept one of the treatment alternatives.

Interventions

• All the interventions will start within 2-3 weeks after randomisation

Decompression surgery

• Anterior discectomy• The disc is incided and the corpora are distracted to perform

discectomy. Usually the posterior ligament is cut and the spinal root is decompressed and if necessary the arthritic rims are removed. An inter-vertebral fusion device is inserted, two levels are allowed in the spondylosis study.

Non-surgical intervention

• The aim of the brief intervention is to promote better understanding and coping of the condition. The intervention will include supervision by a physiotherapist (6 sessions) and provide advice on how to handle secondary neck muscle pain and dysfunction, reduce eventual fear avoidance, and advice to stay active.

The primary outcomes

• The Neck Disability Index• NRS arm pain

• Primary end point at 12 months

Secondary outcomes

• EQ-5D and costs to evaluate cost-effectiveness in study 3; • Prognostic factors in study 4; • CT and MRI to estimate intervertebral foraminal area and nerve root

compression in study 5; • Expected minimal improvement for willingness to undergo treatment

in study 6.

Trial registration and status

• This study has been registered at ClinicalTrials.gov as NCT03674619 on September 17, 2018.

• Currently recruiting, the first patient included in October 2018