Can Sciatica Patients Avoid Surgery?

NCT ID: NCT03572452

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2020-12-31

Brief 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.

Conditions

Sciatic Nerve Compression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

McKenzie - method group

Participants will be sent to an experienced MDT therapist for therapy. They are 1) assessed clinically, 2) treated according the MDT-approach which includes home exercise program, consisting i) an educational component, and ii) an active therapy component with directional preference exercises, several times a day with sustained end range positions according to symptom response, and with avoiding aggravating positions. Participants have a maximum of 7 treatment visits. They will also have physiotherapy counselling at study entry about the good prognosis of sciatica.

Group Type: EXPERIMENTAL

McKenzie Method

Intervention Type: BEHAVIORAL

Treatment according to the Mechanical Diagnosis and Therapy Approach

Advice to stay active group

Participants enrolled into this group will receive physiotherapist's counselling at study entry for at least 60 minutes time about the good prognosis of sciatica, the spontaneous regression of the intervertebral disc herniation and pain tolerance ("natural healing"). In addition, they will get ergonomic advice and advice to stay normally active. The participants are also told to avoid bed rest and advised to continue their normal routines as actively as possible including exercise activities with limits permitted by their signs and symptoms. A two-page summary booklet related to these items will be given to them.

Group Type: ACTIVE_COMPARATOR

Advice to saty active

Intervention Type: BEHAVIORAL

Physiotherapy councelling advicing to stay normally active

Interventions

McKenzie Method

Treatment according to the Mechanical Diagnosis and Therapy Approach

Intervention Type: BEHAVIORAL

Advice to saty active

Physiotherapy councelling advicing to stay normally active

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seinajoki Central Hospital

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Central Finland Hospital District

OTHER

Sponsor Role: lead

Responsible Party

Sinikka Kilpikoski, PhD

PT, PhD, researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jari Ylinen, MD,PhD.

Role: STUDY_DIRECTOR

Central Finland HD

Locations

Central Finland Central Hospital,

Jyväskylä, Central Finland, Finland

Countries

Finland

Other Identifiers

CentralFinlandHD

Identifier Type: -

Identifier Source: org_study_id