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Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis

NCT03495661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-12-16

No results posted yet for this study

Summary

Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.

It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.

The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy.

The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.

Conditions

  • Spinal Stenosis
  • Spinal Stenosis Lumbar
  • Degeneration Lumbar Spine
  • Degeneration Spine
  • Neurogenic Claudication Co-Occurrent and Due to Spinal Stenosis of Lumbar Region
  • Pseudoclaudication Syndrome

Interventions

PROCEDURE

Decompression

Central decompression of the stenotic segment(s) with undercutting of the lateral recesses.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Konstantinos Pazarlis, MD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • Sweden

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 NCT03495661 on ClinicalTrials.gov