Back Pain Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | November 1, 2023 |
Est. primary completion date | December 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Israelita Albert Einstein | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein |
Brazil,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sociodemographic characteristics | Age (years), sex (male or female), body mass index (BMI), formal education (years of study), type of occupation (carrying weight or not). | Baseline | |
Primary | 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 | Radiological evaluation | 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 | |
Secondary | 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) | Baseline, 3, 6, 12 and 24 months after surgery | |
Secondary | Change in Psychosocial Risk Prognosis | 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 | |
Secondary | Change in Global Impression of Recovery | Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE) | Baseline, 3, 6, 12 and 24 months after surgery | |
Secondary | Change in Mood Disorders in The setting of Medical Practice | Anxiety and depression aspects will be measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline, 3, 6, 12 and 24 months after surgery | |
Secondary | Change in Disability | Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0. | Baseline, 3, 6, 12 and 24 months after surgery | |
Secondary | Change in Quality life | 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 |
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