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

Study Overview
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Brief Summary
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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).

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

Conditions
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Low Back Pain, Physical Activity

Intervention / Treatment
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* Behavioral: Physical Activity Counselling
* Other: Therapeutic Exercise for LBP
* Other: Superficial Thermotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Usual Care in Primary Health Care in Low back pain patients, consisting in Therapeutic Exercise and Superficial Thermotherapy at home, and a personalized Physical Activity Counseling based on the Cardiovascular Risk of Each Patient | Behavioral: Physical Activity Counselling<br> <br> * Other names: Physical Activity Advice;Other: Therapeutic Exercise for LBP<br> <br> Other: Superficial Thermotherapy<br> <br> |
| Active Comparator: Control<br>Usual Care in Primary Health Care in Low back pain patients, consisting in Therapeutic Exercise and Superficial Thermotherapy at home. | Other: Therapeutic Exercise for LBP<br> <br> Other: Superficial Thermotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Chronic Pain | Graded Chronic Pain Scale | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Physical Activity | International Physical Activity Questionnaire | 1 month | 
| Kinesiophibia | Tampa Scale of Kinesiophobia | 1 month | 
| Catastrophism | Pain Catastrophicing Scale | 1 month | 
| Cardiovascular Risk Factors | American College of Sports Medicine description of 8 Cardiovascular Risk Factors | 1 month | 
| Anxiety and Depression | Hospital Anxiety and Depression Scale | 1 month | 
| Low Back Pain Percieved Disability | Roland Morris Disability Questionnaire | 1 month | 
| Quality of Life | EuroQoL 5D- 5L | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular Risk