Does sensorimotor cortex plasticity predict the development of chronic low back pain: a protocol for a prospective, longitudinal, cohort study

Not Applicable

Completed

• Conditions: Acute low back pain; Musculoskeletal - Normal musculoskeletal and cartilage development and function; Neurological - Other neurological disorders; Chronic low back pain

• Registration Number: ACTRN12619000002189
• Lead Sponsor: euroscience Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-08
• Study Completion: 2019-07-25
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Eligible participants must be 18 years or older and currently experiencing acute non-specific low back pain - defined as pain in the region of the lower back, superiorly bound by the thoracolumbar junction and inferiorly by the gluteal fold. Participants remain eligible if they have pain referred beyond this region that is not suspected radicular pain from neural tissue involvement. Pain must have been present for more than 24 hours and less than 6 weeks duration following a period of at least 1-month pain-free. As we aim to determine which variables predict low back pain outcome, regardless of whether this is the first episode of pain, participants need not be experiencing their first low back pain episode. Previous history of low back pain will be included as a candidate predictor in the statistical model. Participants must provide written informed consent to participate and be able to speak and read English.

Exclusion Criteria

Known or suspected serious spinal pathology (fracture; malignancy, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder); suspected or confirmed pregnancy or less than six months’ post-partum; suspected radicular pain (dominant leg pain, positive neural tissue provocation tests and/or any two of altered strength, reflexes, or sensation for the same nerve root, assessed clinically); previous lumbar spinal surgery (e.g. spinal fusion, intervertebral disc replacement); presence of another painful condition (e.g. fibromyalgia, neuropathy, rheumatoid arthritis); comorbidities affecting sensorimotor function or causing neurological deficit (e.g. multiple sclerosis, spinal cord injury); history of psychological disorders requiring medication for symptom control (e.g. major depressive disorder, bipolar disorder, schizophrenia) and/or contraindications to transcranial magnetic stimulation.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity: Participants complete the Brief Pain Inventory (BPI) at where they are asked to score their pain intensity on average over the previous week using an eleven-point numerical rating scale (NRS: 0 = no pain”, 10 = worst pain imaginable”). At T2 a NRS score less than or equal to 1 will be classified as recovered low back pain and a NRS score greater than or equal to 2 will be classified as chronic low back pain. <br><br>[Basline - T1<br>6 month follow up - T2]

Secondary Outcome Measures

Name	Time	Method
Disability: Participants complete the 24-point Roland Morris Disability Questionnaire (RMDQ). This questionnaire aims to detect the level of disability experienced as a result of low back pain. At T2 a RMDQ score less than or equal to 6 will be classified as recovered low back pain and a RMDQ score greater than or equal to 7 will be classified as chronic low back pain.[Basline - T1<br>6 month follow up - T2]