Sciatic Nerve Compression Clinical Trial
Official title:
Can Sciatica Patients Due to Intervertebral Disc Herniation Avoid Surgery by Treatment Using the McKenzie Method or by Advice to Stay Active?
Sciatica pain is associated with a disc disorder in 85% of cases. Sciatica is shown to resolve without treatments in the majority of cases. Spontaneous regression of the intervertebral disc herniation occurs where the herniation loses its volume partly or totally without surgical interventions. It has estimated that only 5 to 20% of patients with symptomatic intervertebral disc herniation require surgery. Most trials comparing surgical trials and conservative treatments of sciatica due to intervertebral disc herniation favor surgery, because it results in earlier relief of pain. However, one year after surgery, there were only a few differences in pain and disability between surgery and conservative treatment groups. It has shown that the number of surgeries (discectomies) decreased among patients with sciatica when treated by using a mechanical diagnosis and therapy approach (MDT) also called the McKenzie method. In addition, by using the MDT method it has also been shown that sciatica patient who were clinically classified as "centralizers" had good to excellent non-surgical outcomes and many of them avoided surgery, whereas non-centralizing pain has shown to predict worse treatment outcomes, chronic low back disorder and disability. Further, patients who do not have centralization will be 6 times more likely to undergo surgery.The primary aim of this multicenter randomized clinical trial is to find out how many patients with sciatica due to intervertebral disc herniation with radicular symptoms for at least 6 weeks, and who are on the waiting list for surgery, avoid surgery by treatment using the McKenzie method compared to advice to stay active. Secondary aims are to compare the patients' self-reported outcomes such as low back and leg pain intensity, disability, work ability, sick-leave days, fear avoidance beliefs, kinesiophobia, depression and quality of life. The outcomes are measured at baseline, two and three months in the non-surgical patients. In addition, in the patients who have surgery the outcomes are measured at baseline and the day before and one month after surgery. Follow-up measurements are at 12 and 24 months
One hundred seventy two (N=172) patients with sciatica for at least six weeks with radicular pain below the knee will be involved this study. The patients with non-urgent referrals due to sciatica symptoms will be directed to specialized medical care hospitals (the district central hospitals of Central Finland and South Ostrobothnia and the University hospital of Kuopio, Finland) to the physiatrists and orthopedic outpatient clinics for further investigations for possible surgery. The patient will be seen for a doctor's examination within a week. If the clinical examination reveals that a patient needs spinal disc herniation surgery, and the patient is willing to undergo surgery, they will be referred for X-ray imaging if it has not already been done in basic health care, in accordance with the regular treatment procedure, and to an MRI scan. While patients are waiting for their MRI scan, they will undergo a clinical McKenzie-based mechanical assessment and be put into sub-groups of "centralizers"or "non-centralizers". These will be randomly assigned into a McKenzie group and into an advice to stay active group. Based on their MRI findings and clinical signs and symptoms they will be assigned to surgery or continue their non-surgical treatments. If the MRI scan does not reveal a spinal disc herniation finding that fulfills the criteria of the study, the patient is removed from the study in accordance with the selection criteria, regardless of whether they belong to the MDT or advice to stay active group, and their treatment will continue according to the hospital's normal procedures. ;