The Brain Activity Changes in the Development of Chronic Low Back Pain

NCT05352594 | Unknown

• 1 other identifier: YM111017E
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.

Conditions

Chronic Pain; Low Back Pain

Keywords

Pain Chronicity; Low Back Pain; Electroencephalography; Brain Activity

Outcome Measures

Primary Outcomes (5)

• Pain Intensity at the enrollment

  The average pain intensity in the past week will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").

  at the enrollment

• Pain Intensity at 24-week follow-up

  The average pain intensity in the past week will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").

  at 24-week follow-up

• Brain Activity Change from enrollment to 6-month follow-up

  Participants' brain activity will be measured by electroencephalography (EEG) during functional reaching activity to assess the brain changes.

  at the enrollment and 24-week follow-up

• Pain intensity during functional reaching task at the enrollment

  The pain intensity during functional reaching task will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").

  at the enrollment

• Pain intensity during functional reaching task at 24-week follow-up

  The pain intensity during functional reaching task will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").

  at 24-week follow-up

Study Arms (2)

Chronic Low Back Pain

The participants whose low back pain intensity score ≥2 by numeric pain rating scale at 24-week follow-up.

Recovered Low Back Pain

The participants whose low back pain intensity score \<1 by numeric pain rating scale at 24-week follow-up.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population from community and local clinics will be selected.

You may qualify if:

• Age≧ 20 y/o
• This is the 1st episode of low back pain in the past year
• Pain in the region of the lower back (bound by the thoracolumbar junction superiorly, and by the gluteal fold inferiorly)
• Pain duration \< 12 weeks
• Average pain intensity in the past 7 days is ≧ 3/10 (Numeric Rating Scale)
• Mini-Mental State Examination ≧ 24

You may not qualify if:

• Pain onset duration \< 7 days
• History of chronic pain
• Pain area other than the specify area
• Any systematic disease, fracture or cancer
• Present any neurological sign related to pain
• Infection
• Received any brain or spine surgeries, hip arthroplasty or any other kind of surgeries in the past 3 months
• Diagnosed with any neurological or psychological disease

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Ray-Yau Wang, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray-Yau Wang, PhD

CONTACT

+886-2-2826-7210; rywang@nycu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 29, 2022
• Study Start: September 16, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)