Impact of Muscle Degeneration in Chronic Low Back Pain

March 16, 2021 updated by: Hospital Israelita Albert Einstein

Impact of Muscle Degeneration in Chronic ow Back Pain in Patients Undergoing Neural Decompression

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective cohort study. 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).

The cohort will be followed by a team researcher (not blinded to the purpose of the study) at preoperative (up to 1 month before surgery), immediate postoperative (12 to 24 hours after procedure), 06, 12 and 24 months after surgery. Imaging tests will be performed on the preoperative evaluation and at six months follow-up after the operation.

The treatment will consist of lumbar decompression surgery, which may consist of discectomy, foraminotomy or laminectomy, according to the type and location of the compression. The choice of surgical technique will be made by the assistant surgeon.

Patients will be divided into four groups regarding the type of soft tissue retractor and image magnification:

Group 1: (minimally invasive microdiscectomy): surgeries performed with loupes or microscope plus minimally invasive soft tissue retractors (tubular or "Caspar").

Group 2: (open microdiscectomy) surgeries performed with loupes or microscope plus conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").

Group 3: (endoscopic discectomy): surgeries performed by means of the "full endoscopic" technique;

Group 4: (open discectomy "with the naked eye"): surgeries performed without image magnification. Use of conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").

Image Evaluation:

  1. X-Rays (anteroposterior, lateral, dynamic lateral films) - to evaluate and measure the presence of scoliosis, spondylolisthesis or Degenerative vertebral dislocations.
  2. MRI: to detect and to grade the presence of fat infiltration of the Psoas and Multifidus muscles (Arabanas et al); to grade Modic Signal and facet joint degeneration (Weishaupt et al).

Sample size:

For the sample size estimation, we considered the main outcome of the study, a 1.5-point change in the pain scale (VAS) among patients with fat infiltration (grades 1, 2, or 3) and without fat infiltration (grade 0), after 6 months of spine surgery, with 80% power and 95% confidence, the sample required for the study is 28 patients in each group considering a two-tailed test. Similarly to the previous study, we observed that the first 14 patients in the pilot study, 20% of patients had without fat infiltration, therefore, as the admission of patients into the study is consecutive, we expect to find this same percentage of patients without fat infiltration in the final sample of patients, so 140 patients are needed to get 28 patients without fat infiltration. Predicting a loss of 20% of patients at 6 months of follow-up, the initial sample to be considered will be 168 patients to obtain the minimum number of patients required in each group.

Statistics:

Numerical variables with normal distribution will be described by means and standard deviations and variables with non-normal distribution by medians and interquartile ranges, in addition to the minimum and maximum values. The distributions of numerical variables will be verified by histograms, boxplots, and, if necessary, Shapiro-Wilk normality tests. Categorical variables will be described by absolute frequencies and percentages. The analyzes will be performed with the SPSS26 program, considering a 5% significance level.

Study Type

Observational

Enrollment (Anticipated)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05601-901
        • Recruiting
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological evaluation
Time Frame: Baseline and 6 month after surgery
Magnetic resonance imaging (MRI) reading parameters of Paravertebral and Psoas major fat tissue infiltration follow the standardized institutional protocol for spine evaluation.
Baseline and 6 month after surgery
Change in Kinesiophobia
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
Assessment of fear avoidance beliefs related to physical activity and work will be evaluated by the questionnaire Fear avoidance Beliefs Questionnaire (FABQ)
Baseline, 3, 6, 12 and 24 months after surgery
Change in Psychosocial Risk Prognosis
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool.
Baseline, 3, 6, 12 and 24 months after surgery
Change in Global Impression of Recovery
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)
Baseline, 3, 6, 12 and 24 months after surgery
Change in Mood Disorders in The setting of Medical Practice
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
Anxiety and depression aspects will be measured by the Hospital Anxiety and Depression Scale (HADS)
Baseline, 3, 6, 12 and 24 months after surgery
Change in Disability
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0.
Baseline, 3, 6, 12 and 24 months after surgery
Change in Quality life
Time Frame: Baseline, 3, 6, 12 and 24 months after surgery
EuroQoL will be combined with a Visual Analogue Scale(VAS) to carry out the cost-effectiveness analysis of the second opinion program.
Baseline, 3, 6, 12 and 24 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic characteristics
Time Frame: Baseline
Age (years), sex (male or female), body mass index (BMI), formal education (years of study), type of occupation (carrying weight or not).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Alberto Gotfryd, PhD, Phisician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 6, 2020

Primary Completion (ANTICIPATED)

December 27, 2022

Study Completion (ANTICIPATED)

November 1, 2023

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (ACTUAL)

February 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94868618.7.0000.0071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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