Surgical Decompression Associated With Physical Therapy and Physical Therapy Isolated in Patients With Lumbar Stenosis.

NCT02879461 | Completed DMC

• 1 other identifier: 16127913.4.0000.5505
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow ligament, the articular capsule and the intervertebral disk. These changes decrease the area of the spinal canal and press the neural structures and may present clinically as the narrow tunnel syndrome. This presentation was first described by Verbiest associated with these anatomical changes the clinical manifestations; corresponding to low back pain, pain in the legs that worsen with the fact ambulate and improve with rest, this presentation called neurogenic claudication . The lumbar canal stenosis was divided into two main types; congenital and acquired . The first is associated with a reduced size of the pedicles, which leads to a reduction of the diameter of the spinal canal, common in patients achondroplasics . The acquired is considered the most common type and is associated with aging, including all anatomical structures of the lumbar segment . With an aging population the number of symptomatic patients is increasing, although there is no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical approaches to the spine in patients over 60 years of age (7). As described by Daffner et al a reduction in blood flow leads to production of inflammatory mediators, which associated with anatomical changes previously described lead to the clinical picture with lameness and pain in the lower limbs Treatment of these patients is beginning with guidance on the disease, adequate pain control, physical therapy and exercise for maintaining the activities of daily living. If these measures fail a surgical approach may be necessary, especially in patients with exercise intolerance, difficulty walking and urinary incontinence . The surgical approach despite being widely studied in the literature prospective controlled studies are rare, found series of case studies or retrospective studies, we try to evaluate the effectiveness of surgery compared to rehabilitation in symptomatic patients in an attempt to assess the impact of surgery associated with comparing therapy with isolated therapy in these patients.

Conditions

LUMBAR STENOSIS

Keywords

SURGERY; REHABILITATION

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  Measured using the VAS

  Baseline, after 4, 12, 24 and 48 weeks

Secondary Outcomes (4)

• Change in function

  Baseline, after 4, 12, 24 and 48 weeks

• Change in function

  Baseline, after 4, 12, 24 and 48 weeks

• Change in walking distance

  Baseline, after 4, 12, 24 and 48 weeks

• Change in quality of life

  Baseline, after 4, 12, 24 and 48 weeks

Study Arms (2)

Lumbar Decompression plus Physical Therapy

ACTIVE COMPARATOR

First group will be submitted to lumbar decompression L3 to S1 and physical therapy with exercise Application of questionnaires Oswestry Rolland moris Sf 36 Of 6minutos walk test Likert scale Use of paracetamol

Procedure: LUMBAR DESCOMPRESSION

Physical Therapy

ACTIVE COMPARATOR

Second group physical therapy alone, with exercises Application of questionnaires Oswestry Rolland moris Sf 36 Of 6minutos walk test Likert scale Use of paracetamol

Procedure: LUMBAR DESCOMPRESSION

Interventions

LUMBAR DESCOMPRESSION PROCEDURE

ATRODESIS AND DESCOMPRESSIO OFF VERTEBRAL CANAL

Also known as: LUMBAR STENOSIS

Lumbar Decompression plus Physical Therapy; Physical Therapy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• claudication Presence less than 100m ambulation;
• Pain in the lower limbs;
• Weakness in lower limbs;
• Burning in the lower limbs;
• Tingling in the lower limbs;
• Low back pain;
• the lower spinal canal area to 100mm2, at the discretion of Hamanishi.

You may not qualify if:

• decompensated diabetes mellitus;
• Systemic hypertension and decompensated heart disease;
• Systemic diseases to occur in the lower limbs;
• Neuromuscular diseases;
• Patients with previous surgery in the lumbar or thoracic spine;
• Cognitive impairment that interferes with the ability to understand or interpret the questionnaires;

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Santa Mareclina Hospital

São Paulo, 08270-070, Brazil

Location

Related Publications (1)

• Rodrigues LCL, Natour J. Surgical treatment for lumbar spinal stenosis: a single-blinded randomized controlled trial. Adv Rheumatol. 2021 May 12;61(1):25. doi: 10.1186/s42358-021-00184-6.

  PMID: 33980309 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Of Orthopedics And Traumatology Discipline Medical School Santa Marcelina

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 25, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)