Impact of Muscle Degeneration in Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
need for lumbar arthrodesis;
deep infection requiring surgical cleaning;
patients submitted to joint facet rhizotomy;
active rheumatologic disease, including seronegative arthropathies.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lumbar decompressive surgery
Procedure/SurgeryPatients 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Pain Intensity
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
Time frame
Baseline, 3, 6, 12 and 24 months after surgerySecondary outcomes
1
Radiological evaluation
Magnetic resonance imaging (MRI) reading parameters of Paravertebral and Psoas major fat tissue infiltration follow the standardized institutional protocol for spine evaluation.
Time frame
Baseline and 6 month after surgery2
Change in Kinesiophobia
Assessment of fear avoidance beliefs related to physical activity and work will be evaluated by the questionnaire Fear avoidance Beliefs Questionnaire (FABQ)
Time frame
Baseline, 3, 6, 12 and 24 months after surgery3
Change in Psychosocial Risk Prognosis
Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool.
Time frame
Baseline, 3, 6, 12 and 24 months after surgery4
Change in Global Impression of Recovery
Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)
Time frame
Baseline, 3, 6, 12 and 24 months after surgeryOther outcomes
1
Sociodemographic characteristics
Age (years), sex (male or female), body mass index (BMI), formal education (years of study), type of occupation (carrying weight or not).
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov