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Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-surgical treatment
Surgical treatment for spinal stenosis
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmatory imaging study (MRI or CT) showing lumbar spinal stenosis at one or more levels (L2 to sacrum) defined as narrowing of the central spinal canal, lateral recesses, or neural foramens due to encroachment on the neural structures by the surrounding bone and soft tissue.

Exclusion Criteria:

  • Patients are not eligible if they have evidence of instability on lateral flexion- extension radiographs, defined as a change of #10° of angulation of adjacent segments by Cobb measurement or a change of more than 4 mm of anteroposterior or posteroanterior translation.

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-surgical treatment

Surgical treatment

Arm Description

Different types of non-surgical treatments

Surgical treatment for spinal stenosis

Outcomes

Primary Outcome Measures

Back and leg pain assessed by VAS
Self-administered questionnaires for patients to evaluate back and leg pain (VAS score)
Functional activity assessed by ODI
Self-administered questionnaires for patients to evaluate a disability index (ODI)
Quality of life assessed by EQ-5D
Self-administered questionnaires for patients to evaluate the quality of life (EQ-5D)

Secondary Outcome Measures

Complications
Evaluation of complications associated to the surgical treatment

Full Information

First Posted
March 1, 2017
Last Updated
March 29, 2022
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05315466
Brief Title
Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis
Official Title
Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 8, 2012 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to compare the outcomes of surgical treatment and conservative treatment at medium- and long-term period (minimum 2 years) in patients with lumbar stenosis who come to the observation of the PI's Team at the Rizzoli Orthopaedic Institute, through a series exhaustive questionnaires to self-administer to patients in order to define a path of "decision-making" as effective as possible for the patient and the doctor.
Detailed Description
Non-surgical treatment: Conservative treatment may include different approaches, such as analgesics, anti-inflammatories, muscle relaxants, physical therapy, Global Postural Rehabilitation, magnetic therapy, laser therapy, TENS, massage, cognitive-behavioral therapy and all those procedures that can bring benefit in back and legs pain. Surgical treatment: Surgical treatment of lumbar stenosis is the decompression surgery which relieves the nerve structures to prevent permanent neurological damage. Decompression can be made on one or more segments of the spine and can be done with laminectomy, hemilaminectomy, laminotomy. During a laminotomy part of the vertebral lamina is removed above and below the compressed nerve. The opening created is sometimes enough to relieve the compression on the nerve. In most cases, also the disc material and bone spur that compress the nerve are removed. During a laminectomy the vertebral lamina is completely removed, along with the disc and the bone material that compress the nerves. The opening produced by the removal of the lamina is protected by back muscles and ligaments. If the damage has occurred at several levels and bone of the vertebral support structures must be removed to achieve decompression, it can be performed a stabilization surgery with vertebral bone fusion (arthrodesis) in order to avoid instability of the column. Fusion is carried out to eliminate the mobility between different vertebrae and it is achieved using bone derived from the patient's iliac crest or from a donor. The bone gradually grows and melts with the same vertebrae. This limits the movements that may have been one of the causes of back pain. It takes about six months for it to achieve a solid bony spinal fusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients affected by lumbar spinal stenosis who are designated to surgical or conservative treatment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-surgical treatment
Arm Type
Experimental
Arm Description
Different types of non-surgical treatments
Arm Title
Surgical treatment
Arm Type
Experimental
Arm Description
Surgical treatment for spinal stenosis
Intervention Type
Procedure
Intervention Name(s)
Non-surgical treatment
Intervention Description
Analgesics, anti-inflammatories, muscle relaxants, physical therapy, Global Postural Rehabilitation, magnetic therapy, laser therapy, transcutaneous electrical nervous stimulation (TENS), massage, cognitive-behavioral therapy and all those procedures that can bring benefit to back and leg pain.
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment for spinal stenosis
Intervention Description
Decompression of nerve structures by laminotomy or laminectomy and posterior lumbar fusion if stabilization of the column is required.
Primary Outcome Measure Information:
Title
Back and leg pain assessed by VAS
Description
Self-administered questionnaires for patients to evaluate back and leg pain (VAS score)
Time Frame
Change from baseline VAS at 3, 6, 12, 24 months
Title
Functional activity assessed by ODI
Description
Self-administered questionnaires for patients to evaluate a disability index (ODI)
Time Frame
Change from baseline ODI at 3, 6, 12, 24 months
Title
Quality of life assessed by EQ-5D
Description
Self-administered questionnaires for patients to evaluate the quality of life (EQ-5D)
Time Frame
Change from baseline EQ-5D at 3, 6, 12, 24 months
Secondary Outcome Measure Information:
Title
Complications
Description
Evaluation of complications associated to the surgical treatment
Time Frame
6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmatory imaging study (MRI or CT) showing lumbar spinal stenosis at one or more levels (L2 to sacrum) defined as narrowing of the central spinal canal, lateral recesses, or neural foramens due to encroachment on the neural structures by the surrounding bone and soft tissue. Exclusion Criteria: Patients are not eligible if they have evidence of instability on lateral flexion- extension radiographs, defined as a change of #10° of angulation of adjacent segments by Cobb measurement or a change of more than 4 mm of anteroposterior or posteroanterior translation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Gasbarrini, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21311394
Citation
Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.
Results Reference
background
PubMed Identifier
10828926
Citation
Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F. Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Spine (Phila Pa 1976). 2000 Jun 1;25(11):1424-35; discussion 1435-6. doi: 10.1097/00007632-200006010-00016.
Results Reference
background
PubMed Identifier
17202885
Citation
Malmivaara A, Slatis P, Heliovaara M, Sainio P, Kinnunen H, Kankare J, Dalin-Hirvonen N, Seitsalo S, Herno A, Kortekangas P, Niinimaki T, Ronty H, Tallroth K, Turunen V, Knekt P, Harkanen T, Hurri H; Finnish Lumbar Spinal Research Group. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phila Pa 1976). 2007 Jan 1;32(1):1-8. doi: 10.1097/01.brs.0000251014.81875.6d.
Results Reference
background
PubMed Identifier
18287602
Citation
Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
Results Reference
background
PubMed Identifier
15959362
Citation
Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1.
Results Reference
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Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis

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