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Clinical Trials/NCT03886636
NCT03886636
Completed
Not Applicable

The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients with Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial

Kutahya Health Sciences University1 site in 1 country69 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Kutahya Health Sciences University
Enrollment
69
Locations
1
Primary Endpoint
Numeric pain rating scale (NPRS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
January 1, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Kutahya Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Ismail Saracoglu

Principle Investigator

Kutahya Health Sciences University

Eligibility Criteria

Inclusion Criteria

  • Volunteered to participate in the study.
  • Patients with 18-65 years
  • Had low back pain for at least 6 months,
  • Reported pain severity of 5 or greater according to the numeric pain rating scale
  • Used pregabalin and gabapentin derivatives,

Exclusion Criteria

  • Previous spine or lower extremity surgery
  • Severe osteoporosis
  • Spondyloarthropathy
  • Spondylolisthesis
  • Lumbar stenosis
  • Systemic inflammatory diseases

Outcomes

Primary Outcomes

Numeric pain rating scale (NPRS)

Time Frame: Change from Baseline NPRS at 4th weeks and 12th weeks

The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.

Secondary Outcomes

  • Oswestry Disability Index (ODI)(Change from Baseline ODI at 4th weeks and 12th weeks)
  • Back Performance Scale (BPS)(Change from Baseline BPS at 4th weeks and 12th weeks)
  • Tampa Scale for Kinesiophobia (TSK)(Change from Baseline TSK at 4th weeks and 12th weeks)

Study Sites (1)

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