Can Sciatica Patients Avoid Surgery?
Condition: Sciatic Nerve Compression
MeSH terms: Sciatica
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): McKenzie Method; Advice to saty active
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment according to the Mechanical Diagnosis and Therapy Approach; Physiotherapy councelling advicing to stay normally active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment