Can Sciatica Patients Avoid Surgery?

NCT03572452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2021-09-02

No results posted yet for this study

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

Conditions

  • Sciatic Nerve Compression

Interventions

BEHAVIORAL

McKenzie Method

Treatment according to the Mechanical Diagnosis and Therapy Approach

BEHAVIORAL

Advice to saty active

Physiotherapy councelling advicing to stay normally active

Sponsors & Collaborators

  • Seinajoki Central Hospital

    collaborator OTHER
  • Kuopio University Hospital

    collaborator OTHER
  • Central Finland Hospital District

    lead OTHER

Principal Investigators

  • Jari Ylinen, MD,PhD. · Central Finland HD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572452 on ClinicalTrials.gov