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Clinical Trials/NCT02837653
NCT02837653
Completed
N/A

Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk

Universidad Autonoma de Madrid1 site in 1 country64 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad Autonoma de Madrid
Enrollment
64
Locations
1
Primary Endpoint
Severity of Chronic Pain
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Objective: To determine the influence of a counseling of physical activity (PA) versus usual care (UC) in the magnitude of chronic pain (CP) in patients diagnosed with chronic low back pain (CLBP).

Methods: A total of 64 subjects with (CLBP) and older were randomly divided into two groups: an experimental group (UC) + counseling of (AF) and control group (UC). Each group consisted of 32 participants and were evaluated twice (pre and post-intervention), being spaced one month, both groups received telephone follow-up for their participation. The primary endpoint was the magnitude of the (CP) measured by the tool grading scale of chronic pain (EGDC), while as secondary were considered the cardiovascular risk factors, catastrophism, kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (FA).

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raúl Ferrer-Peña

Principal Investigator

Universidad Autonoma de Madrid

Eligibility Criteria

Inclusion Criteria

  • Patients with low back pain more than 3 months
  • Age over 18 years old
  • Low or Medium Cardiovascular Risk

Exclusion Criteria

  • Cardiovascular Risk Factors ≥ 5
  • Quirurgic procedures at spine last 10 years
  • Past of Cancer, or Fibromialgia

Outcomes

Primary Outcomes

Severity of Chronic Pain

Time Frame: 1 month

Graded Chronic Pain Scale

Secondary Outcomes

  • Anxiety and Depression(1 month)
  • Quality of Life(1 month)
  • Amount of Physical Activity(1 month)
  • Catastrophism(1 month)
  • Kinesiophibia(1 month)
  • Cardiovascular Risk Factors(1 month)
  • Low Back Pain Percieved Disability(1 month)

Study Sites (1)

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