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Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis (UppSten)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495661
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief 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.


Condition or disease Intervention/treatment Phase
Spinal Stenosis Spinal Stenosis Lumbar Degeneration Lumbar Spine Degeneration Spine Neurogenic Claudication Co-Occurrent and Due to Spinal Stenosis of Lumbar Region Pseudoclaudication Syndrome Procedure: Decompression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective clinical randomised clinical trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Uppsala Spinal Stenosis Study
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Surgical (Decompression)
Central decompression of the stenotic segment(s) with undercutting of the lateral recesses.
Procedure: Decompression
Central decompression of the stenotic segment(s) with undercutting of the lateral recesses.
Other Name: Laminectomy

No Intervention: Non-surgical
Physical therapy according to the "Östersund model": training on stationary bicycle 30 min, 3 times/week under 4 months.



Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline ]
    Through the Swedish National Spine Registry (SweSpine)

  2. Oswestry Disability Index (ODI) [ Time Frame: 6 months ]
    Through the Swedish National Spine Registry (SweSpine)

  3. Oswestry Disability Index (ODI) [ Time Frame: 1 year ]
    Through the Swedish National Spine Registry (SweSpine)

  4. Oswestry Disability Index (ODI) [ Time Frame: 2 years ]
    Through the Swedish National Spine Registry (SweSpine)

  5. Oswestry Disability Index (ODI) [ Time Frame: 5 years ]
    Through the Swedish National Spine Registry (SweSpine)


Secondary Outcome Measures :
  1. Motor Amplitude (ENG) [ Time Frame: Baseline and 6 months postoperatively ]
  2. Denervation Activity (EMG) [ Time Frame: Baseline and 6 months follow-up ]
  3. Sensory Amplitude (ENG) [ Time Frame: Baseline and 6 months follow-up ]
  4. Late Responses (F-wave and H.Reflex) [ Time Frame: Baseline and 6 months follow-up ]
  5. Motor Unit Number Index (MUNIX) [ Time Frame: Baseline and 6 months follow-up ]
  6. Grade of Reinnervation (EMG) [ Time Frame: Baseline and 6 months follow-up ]
  7. EQ-5D [ Time Frame: Baseline and 6 months, 1, 2, 5 years follow-up ]
    Through the Swedish National Spine Registry (SweSpine)

  8. NRS for Low Back and Leg Pain [ Time Frame: Baseline and 6 months, 1, 2, 5 years follow-up ]
    Through the Swedish National Spine Registry (SweSpine)

  9. Subjective Walking Ability [ Time Frame: Baseline and 6 months, 1, 2, 5 years follow-up ]
    Through the Swedish National Spine Registry (SweSpine)

  10. Global Assessment (GA) [ Time Frame: Baseline and 6 months, 1, 2, 5 years follow-up ]
    Through the Swedish National Spine Registry (SweSpine)

  11. Patient Satisfaction [ Time Frame: Baseline and 6 months, 1, 2, 5 years follow-up ]
    Through the Swedish National Spine Registry (SweSpine)

  12. Objective Walking Ability [ Time Frame: Baseline and 6 months, 1, 2 years follow-up ]
    6 Minutes Walk Test (6MWT)

  13. Lumbar Lordosis (LL) and Sagittal Vertebral Axis (SVA) [ Time Frame: Baseline and 6 months follow-up ]
    Standing Scoliosis X-rays (AP and Lateral view)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Age 50-85 years.
  2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) that indicate and motivate surgery. NRS in lower limbs ≥3.
  3. MRI with finding of LSS at 1-3 lumbar levels. Dural sac area ≤ 75 mm² or degree of stenosis C or D according to Schizas classification.
  4. The surgical treatment to be provided is decompression alone.
  5. The patient has given oral and written informed consent to the participation in the study.

Exclusion criteria

  1. Degenerative deformity with Cobb angle > 20°.
  2. Spondylolysis.
  3. Symptomatic osteoarthritis in the lower limbs that affects and limits their function.
  4. Arterial insufficiency (claudication intermittent) .
  5. Past lumbar surgery other than disc hernia.
  6. Conditions that affect the spine such as ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), spondylodiscitis/infections, malignancy, neurological diseases.
  7. Heart and lung diseases that present a significant risk for surgery or make it impossible for the patient to take part in physical training program (ASA>3).
  8. Polyneuropathies.
  9. Psychological factors that make the patient incapable of inclusion in the study (eg drug addiction, dementia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495661


Contacts
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Contact: Konstantinos Pazarlis, MD +46 18-617 41 23‬ konstantinos.pazarlis@surgsci.uu.se
Contact: Peter Försth, MD, PhD +46 18-617 44 17 peter.forsth@surgsci.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Konstantinos Pazarlis, MD    +46186174123    konstantinos.pazarlis@surgsci.uu.se   
Contact: Peter Försth, MD, PhD    +46186174417    peter.forsth@surgsci.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Konstantinos Pazarlis, MD Uppsala University
  Study Documents (Full-Text)

Documents provided by Uppsala University:
Study Protocol  [PDF] March 28, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03495661    
Other Study ID Numbers: u1
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
lumbar spine stenosis
decompression
laminectomy
physiotherapy
physical therapy
electroneurography
ENG
electromyography
EMG
Neurogenic Claudication
Pseudoclaudication
Additional relevant MeSH terms:
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Spinal Stenosis
Intermittent Claudication
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases