Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Back and leg pain assessed by VAS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Non-surgical treatment
Different types of non-surgical treatments
Intervention: Non-surgical treatment (Procedure)
Surgical treatment
Surgical treatment for spinal stenosis
Intervention: Surgical treatment for spinal stenosis (Procedure)
Outcomes
Primary Outcomes
Back and leg pain assessed by VAS
Time Frame: Change from baseline VAS at 3, 6, 12, 24 months
Self-administered questionnaires for patients to evaluate back and leg pain (VAS score)
Functional activity assessed by ODI
Time Frame: Change from baseline ODI at 3, 6, 12, 24 months
Self-administered questionnaires for patients to evaluate a disability index (ODI)
Quality of life assessed by EQ-5D
Time Frame: Change from baseline EQ-5D at 3, 6, 12, 24 months
Self-administered questionnaires for patients to evaluate the quality of life (EQ-5D)
Secondary Outcomes
- Complications(6, 12, 24 months)