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

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ClinicalTrials.gov Identifier: NCT02837653
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Raúl Ferrer-Peña, Universidad Autonoma de Madrid

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).


Condition or disease Intervention/treatment Phase
Low Back Pain Physical Activity Behavioral: Physical Activity Counselling Other: Therapeutic Exercise for LBP Other: Superficial Thermotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
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
Other Name: Physical Activity Advice

Other: Therapeutic Exercise for LBP
Other: Superficial Thermotherapy
Active Comparator: Control
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
Other: Superficial Thermotherapy



Primary Outcome Measures :
  1. Severity of Chronic Pain [ Time Frame: 1 month ]
    Graded Chronic Pain Scale


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837653


Locations
Spain
CS Entrevías
Madrid, Spain, 28053
Sponsors and Collaborators
Universidad Autonoma de Madrid

Publications:
Responsible Party: Raúl Ferrer-Peña, Principal Investigator, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02837653     History of Changes
Other Study ID Numbers: CEULS-PI-108/2016
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Raúl Ferrer-Peña, Universidad Autonoma de Madrid:
cardiovascular Risk

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms