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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837653
• Other study ID #: CEULS-PI-108/2016
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: July 15, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• 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

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Physical Activity

Intervention

Behavioral:
• Physical Activity Counselling

Other:
• Therapeutic Exercise for LBP

• Superficial Thermotherapy

Locations

Country	Name	City	State
Spain	CS Entrevías	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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

Outcome

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