Sciatic Nerve Compression Clinical Trial
— CASPASOfficial title:
Can Sciatica Patients Due to Intervertebral Disc Herniation Avoid Surgery by Treatment Using the McKenzie Method or by Advice to Stay Active?
| Verified date | September 2021 |
| Source | Central Finland Hospital District |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 162 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Central Finland Central Hospital, | Jyväskylä | Central Finland |
| Lead Sponsor | Collaborator |
|---|---|
| Central Finland Hospital District | Kuopio University Hospital, Seinajoki Central Hospital |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Fear Avoidance | 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". | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups | |
| Other | Kinesiophobia | 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". | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups. | |
| Other | Depression | 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". | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups. | |
| Other | Work ability | 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). | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups. | |
| Other | Sick leave | Number of sick leave days | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups. | |
| Primary | 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 | Pain Intensity | Low back and leg pain intensity reported with Visual Analog Scale (VAS) (0 - 100mm scales, 0 mm = no pain, 100mm = worst possible pain). | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups | |
| Secondary | Disability | 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. | Changes are reported from baseline to short term (3 months), longer term (12months) and in long term (24months) follow-ups. | |
| Secondary | Health-Related Quality of Life | 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. | Changes are reported from baseline to longer term (12months) and in long term (24months) follow-ups |