Low Back Pain Clinical Trial
Official title:
Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk
Verified date | July 2016 |
Source | Universidad Autonoma de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 64 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | CS Entrevías | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Madrid |
Spain,
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. — View 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. — View 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. Epub 2005 Sep 9. Review. — View Citation
Philips HC. Avoidance behaviour and its role in sustaining chronic pain. Behav Res Ther. 1987;25(4):273-9. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of Chronic Pain | Graded Chronic Pain Scale | 1 month | No |
Secondary | Amount of Physical Activity | International Physical Activity Questionnaire | 1 month | No |
Secondary | Kinesiophibia | Tampa Scale of Kinesiophobia | 1 month | No |
Secondary | Catastrophism | Pain Catastrophicing Scale | 1 month | No |
Secondary | Cardiovascular Risk Factors | American College of Sports Medicine description of 8 Cardiovascular Risk Factors | 1 month | No |
Secondary | Anxiety and Depression | Hospital Anxiety and Depression Scale | 1 month | No |
Secondary | Low Back Pain Percieved Disability | Roland Morris Disability Questionnaire | 1 month | No |
Secondary | Quality of Life | EuroQoL 5D- 5L | 1 month | No |
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