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OpenTrials
Completed

NCT Number: NCT02837653

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

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).

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CS Entrevías

Madrid, 28053, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity counselling

Behavioral

Other names: Physical Activity Advice

Therapeutic Exercise for LBP

Other

Superficial Thermotherapy

Other

Primary outcomes

  1. Severity of Chronic Pain

    Time frame: 1 month

    Graded Chronic Pain Scale

Secondary outcomes

  1. Amount of Physical Activity

    Time frame: 1 month

    International Physical Activity Questionnaire

  2. Kinesiophibia

    Time frame: 1 month

    Tampa Scale of Kinesiophobia

  3. Catastrophism

    Time frame: 1 month

    Pain Catastrophicing Scale

  4. Cardiovascular Risk Factors

    Time frame: 1 month

    American College of Sports Medicine description of 8 Cardiovascular Risk Factors

  5. Anxiety and Depression

    Time frame: 1 month

    Hospital Anxiety and Depression Scale

  6. Low Back Pain Percieved Disability

    Time frame: 1 month

    Roland Morris Disability Questionnaire

  7. Quality of Life

    Time frame: 1 month

    EuroQoL 5D- 5L

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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