Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis

NCT03495661 | Completed

• 1 other identifier: u1
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

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

Keywords

lumbar spine stenosis; decompression; laminectomy; physiotherapy; physical therapy; electroneurography; ENG; electromyography; EMG; Neurogenic Claudication; Pseudoclaudication

Outcome Measures

Primary Outcomes (5)

• Oswestry Disability Index (ODI)

  Through the Swedish National Spine Registry (SweSpine)

  Baseline

• Oswestry Disability Index (ODI)

  Through the Swedish National Spine Registry (SweSpine)

  6 months

• Oswestry Disability Index (ODI)

  Through the Swedish National Spine Registry (SweSpine)

  1 year

• Oswestry Disability Index (ODI)

  Through the Swedish National Spine Registry (SweSpine)

  2 years

• Oswestry Disability Index (ODI)

  Through the Swedish National Spine Registry (SweSpine)

  5 years

Secondary Outcomes (13)

• Motor Amplitude (ENG)

  Baseline and 6 months postoperatively

• Denervation Activity (EMG)

  Baseline and 6 months follow-up

• Sensory Amplitude (ENG)

  Baseline and 6 months follow-up

• Late Responses (F-wave and H.Reflex)

  Baseline and 6 months follow-up

• Motor Unit Number Index (MUNIX)

  Baseline and 6 months follow-up

Study Arms (2)

Surgical (Decompression)

ACTIVE COMPARATOR

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

Procedure: Decompression

Non-surgical

NO INTERVENTION

Physical therapy according to the "Östersund model": training on stationary bicycle 30 min, 3 times/week under 4 months.

Interventions

Decompression PROCEDURE

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

Also known as: Laminectomy

Surgical (Decompression)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-85 years.
• Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) that indicate and motivate surgery. NRS in lower limbs ≥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.
• The surgical treatment to be provided is decompression alone.
• The patient has given oral and written informed consent to the participation in the study.

You may not qualify if:

• Degenerative deformity with Cobb angle \> 20°.
• Spondylolysis.
• Symptomatic osteoarthritis in the lower limbs that affects and limits their function.
• Arterial insufficiency (claudication intermittent) .
• Past lumbar surgery other than disc hernia.
• Conditions that affect the spine such as ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), spondylodiscitis/infections, malignancy, neurological diseases.
• 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).
• Polyneuropathies.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (1)

• Pazarlis K, Punga A, Schizas N, Sanden B, Michaelsson K, Forsth P. Study protocol for a randomised controlled trial with clinical, neurophysiological, laboratory and radiological outcome for surgical versus non-surgical treatment for lumbar spinal stenosis: the Uppsala Spinal Stenosis Trial (UppSten). BMJ Open. 2019 Aug 20;9(8):e030578. doi: 10.1136/bmjopen-2019-030578.

  PMID: 31434781 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Decompression; Laminectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Orthopedic Procedures; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Konstantinos Pazarlis, MD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective clinical randomised clinical trial

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 12, 2018
• Study Start: May 4, 2018
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

SE (1)