Can Sciatica Patients Avoid Surgery?

NCT03572452 | Completed

• 1 other identifier: CentralFinlandHD
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Sciatic Nerve Compression

Outcome Measures

Primary Outcomes (1)

• Number of patients who avoided surgery

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

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

Secondary Outcomes (3)

• Pain Intensity

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

• Disability

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

• Health-Related Quality of Life

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

Other Outcomes (5)

• Fear Avoidance

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

• Kinesiophobia

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

• Depression

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

Study Arms (2)

McKenzie - method group

EXPERIMENTAL

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.

Behavioral: McKenzie Method

Advice to stay active group

ACTIVE COMPARATOR

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.

Behavioral: Advice to saty active

Interventions

McKenzie Method BEHAVIORAL

Treatment according to the Mechanical Diagnosis and Therapy Approach

McKenzie - method group

Advice to saty active BEHAVIORAL

Physiotherapy councelling advicing to stay normally active

Advice to stay active group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Finland Hospital District: lead
• Seinajoki Central Hospital: collaborator
• Kuopio University Hospital: collaborator

Study Sites (1)

Central Finland Central Hospital,

Jyväskylä, Central Finland, 40620, Finland

Location

Study Officials

• Jari Ylinen, MD,PhD.

  Central Finland HD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, researcher

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: December 31, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)