Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis

NCT05315466 | Completed

• 1 other identifier: RF MINSAL2009.STENOSI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (3)

• Back and leg pain assessed by VAS

  Self-administered questionnaires for patients to evaluate back and leg pain (VAS score)

  Change from baseline VAS at 3, 6, 12, 24 months

• Functional activity assessed by ODI

  Self-administered questionnaires for patients to evaluate a disability index (ODI)

  Change from baseline ODI at 3, 6, 12, 24 months

• Quality of life assessed by EQ-5D

  Self-administered questionnaires for patients to evaluate the quality of life (EQ-5D)

  Change from baseline EQ-5D at 3, 6, 12, 24 months

Secondary Outcomes (1)

• Complications

  6, 12, 24 months

Study Arms (2)

Non-surgical treatment

EXPERIMENTAL

Different types of non-surgical treatments

Procedure: Non-surgical treatment

Surgical treatment

EXPERIMENTAL

Surgical treatment for spinal stenosis

Procedure: Surgical treatment for spinal stenosis

Interventions

Non-surgical treatment PROCEDURE

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.

Non-surgical treatment

Surgical treatment for spinal stenosis PROCEDURE

Decompression of nerve structures by laminotomy or laminectomy and posterior lumbar fusion if stabilization of the column is required.

Surgical treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

• 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.

  PMID: 21311394 BACKGROUND

• 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.

  PMID: 10828926 BACKGROUND

• 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.

  PMID: 17202885 BACKGROUND

• 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.

  PMID: 18287602 BACKGROUND

• 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.

  PMID: 15959362 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Alessandro Gasbarrini, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients affected by lumbar spinal stenosis who are designated to surgical or conservative treatment

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: April 7, 2022
• Study Start: August 8, 2012
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: April 7, 2022

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)