Clinical trial NCT02837653: Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk
Official title: Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Physical Activity
Keywords: cardiovascular Risk
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Severity of Chronic Pain
timeFrame: 1 month
Secondary outcomes:
measure: Amount of Physical Activity
timeFrame: 1 month
measure: Kinesiophibia
timeFrame: 1 month
measure: Catastrophism
timeFrame: 1 month
measure: Cardiovascular Risk Factors
timeFrame: 1 month
measure: Anxiety and Depression
timeFrame: 1 month
measure: Low Back Pain Percieved Disability
timeFrame: 1 month
measure: Quality of Life
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CS Entrevías
Study officials:
References:
citation: Phillips K, Clauw DJ. Central pain mechanisms in the rheumatic diseases: future directions. Arthritis Rheum. 2013 Feb;65(2):291-302. doi: 10.1002/art.37739. No abstract available.
citation: O'Sullivan P. Diagnosis and classification of chronic low back pain disorders: maladaptive movement and motor control impairments as underlying mechanism. Man Ther. 2005 Nov;10(4):242-55. doi: 10.1016/j.math.2005.07.001. Epub 2005 Sep 9.
citation: Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine (Phila Pa 1976). 2012 May 15;37(11):E668-77. doi: 10.1097/BRS.0b013e318241e5de.
citation: Philips HC. Avoidance behaviour and its role in sustaining chronic pain. Behav Res Ther. 1987;25(4):273-9. doi: 10.1016/0005-7967(87)90005-2. No abstract available.
citation: Lethem J, Slade PD, Troup JD, Bentley G. Outline of a Fear-Avoidance Model of exaggerated pain perception--I. Behav Res Ther. 1983;21(4):401-8. doi: 10.1016/0005-7967(83)90009-8. No abstract available.
citation: Ryan CG, Grant PM, Dall PM, Gray H, Newton M, Granat MH. Individuals with chronic low back pain have a lower level, and an altered pattern, of physical activity compared with matched controls: an observational study. Aust J Physiother. 2009;55(1):53-8. doi: 10.1016/s0004-9514(09)70061-3.