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

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).

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Physical Activity
• Intervention / Treatment: Behavioral: Physical Activity Counselling; Other: Therapeutic Exercise for LBP; Other: Superficial Thermotherapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28053
    • CS Entrevías

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: cardiovascular Risk
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEULS-PI-108/2016