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Completed

NCT Number: NCT03572452

Can Sciatica Patients Avoid Surgery?

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

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Key information

Conditions

Sciatic Nerve Compression

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Central Hospital,

Jyväskylä, Central Finland, 40620, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participants are 18 - 60-year-old Finnish speaking sciatica patients for whom magnetic resonance imaging confirmed disc herniation compressing a nerve root canal, and who have related symptoms radiating to the lower limb +/- neurological disorders. Their sciatica has lasted at least 6 weeks.

Exclusion criteria

Pregnancy, previous surgery or treated by using MDT- method, fibromyalgia, signs of serious diseases or "red-flags" symptoms. Symptoms indicating the Cauda Equina Syndrome (CES) or lower limb palsy that hinders normal functioning, previous injury from a car accident or a high fall, or osteoporotic fractures for the elderly, cancer anamnesis, tumor, or inflammation, general symptoms such as fever, chills, or losing weight for an unknown reason, back problems complicated by other serious diseases such as polyneuropathy, neurological diseases, circulatory brain diseases, central spinal stenosis, myelopathy, syringomyelia, and long-term neuropathic pain not related to sciatica, unwillingness to undergo surgery.

Treatment and study plan

McKenzie Method

Behavioral

Treatment according to the Mechanical Diagnosis and Therapy Approach

Advice to saty active

Behavioral

Physiotherapy councelling advicing to stay normally active

Primary outcomes

  1. Number of patients who avoided surgery

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups

    Number of patients who avoided surgery treated by using the McKenzie- method or by advice to stay active

Secondary outcomes

  1. Pain Intensity

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups

    Low back and leg pain intensity reported with Visual Analog Scale (VAS) (0 - 100mm scales, 0 mm = no pain, 100mm = worst possible pain).

  2. Disability

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups.

    Disability is reported with Oswestry disability index Finnish version 2.0 total score (scale 0-100%): 0= minimal disability, 100 = bed-bound or exaggeration of symptoms.

  3. Health-Related Quality of Life

    Time frame: Changes are reported from baseline to longer term (12months) and in long term (24months) follow-ups

    Quality of life is assessed with the SF-36.These eight scale scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores equals more disability, higher scores equals less disability. Physical and mental components will be calculated separately.

Other outcomes

  1. Fear Avoidance

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups

    Fear-avoidance beliefs about physical activity and work was measures with the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 questions, for each statement has a 7-point Likert scale with scoring alternatives ranging from "0 = completely disagree" to "6 = completely agree".

  2. Kinesiophobia

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups.

    The fear to move was assessed with the Tampa Scale for Kinesiophopia (TSK) questionnaire. It comprises 17 items assessing the subjective rating of kinesiophopia. Each item has a 4-point Likert scale with scoring alternatives ranging from "strongly disagree" to "strongly agree".

  3. Depression

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups.

    Depression during last month is measured with the Depression Scale (DEPS) questionnaire.This self-rating depression scale in Finnish consists of 10 items. Each item has a 4-point scale with alternatives ranging from "0 = not at all" to "3 = very much".

  4. Work ability

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups.

    Work ability is measured with the Visual Analogue Scale (VAS) from 0 to 100mm scales (0 mm = completely able to work and 100mm = unable to work).

  5. Sick leave

    Time frame: Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups.

    Number of sick leave days

Sponsors and collaborators

Lead sponsor

Central Finland Hospital District

Other

Collaborators

  • Kuopio University Hospital
  • Seinajoki Central Hospital

Registry information

Official study title

Can Sciatica Patients Due to Intervertebral Disc Herniation Avoid Surgery by Treatment Using the McKenzie Method or by Advice to Stay Active?

Acronym: CASPAS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2018
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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