Impact of Muscle Degeneration in Chronic Low Back Pain

NCT04273828 | Recruiting

• 1 other identifier: 94868618.7.0000.0071
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability. The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation; Radiculopathy; Back Pain

Keywords

back pain; lumbar disc herniation; lumbar spinal stenosis; Decompression, surgical

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)

  Baseline, 3, 6, 12 and 24 months after surgery

Secondary Outcomes (7)

• Radiological evaluation

  Baseline and 6 month after surgery

• Change in Kinesiophobia

  Baseline, 3, 6, 12 and 24 months after surgery

• Change in Psychosocial Risk Prognosis

  Baseline, 3, 6, 12 and 24 months after surgery

• Change in Global Impression of Recovery

  Baseline, 3, 6, 12 and 24 months after surgery

• Change in Mood Disorders in The setting of Medical Practice

  Baseline, 3, 6, 12 and 24 months after surgery

Other Outcomes (1)

• Sociodemographic characteristics

  Baseline

Interventions

Lumbar decompressive surgery PROCEDURE

Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).

Eligibility Criteria

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

Study Population

The study will be conducted at the Israelita Albert Einstein Hospital (HIAE), a tertiary private philanthropic hospital located in the city of São Paulo, Brazil. All participants will be from and treated at the institution's spine surgery outpatient clinics.

You may qualify if:

• adults 18 years of age and older;
• with symptoms of lumbosacral neural compression (radiculopathy or neurogenic lameness);
• failed conservative treatment for at least 6 weeks;
• undergoing surgery for neural decompression (discectomy and / or foraminotomy and / or hemilaminectomy);
• with complete pre and postoperative medical records in all evaluations.

You may not qualify if:

• need for lumbar arthrodesis;
• deep infection requiring surgical cleaning;
• patients submitted to joint facet rhizotomy;
• active rheumatologic disease, including seronegative arthropathies.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05601-901, Brazil

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Radiculopathy; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Alberto Gotfryd, PhD

  Phisician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Gotfryd, PhD

CONTACT

5511995925225; albertocoluna@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 18, 2020
• Study Start: April 6, 2020
• Primary Completion: December 27, 2024
• Study Completion: June 27, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-11

Locations

BR (1)