The aim of this study is to compare the effects of anterior cervical discectomy versus percutaneous plasma discectomy on pain, on global perceived effect, functional status and health-related quality of life in a group of patients with cervical…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The influence of treatment on the intensity of pain, the global perceived
effect.
Secondary outcome
The functional status and the health-related quality of life and
cost-effectiveness
Background summary
Several treatments exist for the treatment of the cervical radicular syndrome
caused by a contained soft disc hernia. The effects of an open nucleotomy,
physiotherapy and cervical collar were studied by Persson (Feldborg Nielsen,
Annertz et al. 1997; Persson, Carlsson et al. 1997). They concluded that on the
short term pain improved much faster by surgery. On the long term muscle force,
sensibility and pain improved as well.
Kuijper (Kuijper, Tans et al. 2009; Kuijper, Tans et al. 2009) investigated the
effects of conservative treatment for the cervical radicular syndrome, and
concluded that a semi-hard cervical collar and rest for three to six weeks or
physiotherapy accompanied by home exercises for six weeks reduced neck and arm
pain substantially compared with a wait and see policy in the early phase of
cervical radiculopathy.
Cesaroni et al. (Cesaroni and Nardi 2009) studied percutaneous plasma
discectomy and found significantly better clinical outcomes than a conservative
care regimen.
Up till now no studies have been performed that compare the results of
percutaneous plasma discectomy with open nucleotomy.
Since the complications of open nucleotomy include a small risk on local
inflammation, local pain, and a longer period of convalescence, it would be
considered an important improvement, if the same advantages of open nucleotomy
could be achieved with percutaneous plasma discectomy being much less invasive.
Study objective
The aim of this study is to compare the effects of anterior cervical discectomy
versus percutaneous plasma discectomy on pain, on global perceived effect,
functional status and health-related quality of life in a group of patients
with cervical radicular pain caused by a contained soft disc herniation.
Study design
A multicenter randomised controlled parallel-group study
Intervention
Two different treatment methods will be compared in patients with a contained
disc hernia: anterior cervical discectomy and percutaneous plasma discectomy.
Study burden and risks
All two treatments are standard procedures in the participating treatment
centers, so the patients will undergo no additional treatment, and will not be
exposed to any additional risks by participating in the trial. The burden
associated with participation is that they will have to fill out a number of
online questionnaires, and undergo the following tests: Muscle strength; Upper
Limb Activity Monitor, Quantative Sensory Testing, and DNIC, at two regular
clinic visits (T0 and T2), and that they will have to make one extra visit to
the clinic to perform the same tests (T3).
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
Radicular pain of the lower cervical spine (C4-7) with complaints of radicular pain (VAS (0-100) as a result of a contained soft disc hernia with or without neck pain, without improvement in at least 8 weeks of conservative therapy.
Exclusion criteria
Age below 18 and above 65 years; Pregnancy; Anticoagulant drug therapy and/or disturbed coagulation; Infections/ tumours; Previous spinal surgery in cervical region; Extruded disc fragment; bony spurs; calcified disc; Herniation > 5 mm; Disc: maximal 50% loss of height; Neurodegenerative diseases, including lesions of the spinal cord; Lack of cooperation of the patient; Patients who are not able to complete the questionnaires, according to the referring doctor; Drugs/medication/ alcohol addiction; Serious psychopathology;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL32745.078.10 |