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

Primary Purpose

Low Back Pain, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Activity Counselling
Therapeutic Exercise for LBP
Superficial Thermotherapy
Sponsored by
Universidad Autonoma de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring cardiovascular Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CS Entrevías

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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

Usual Care in Primary Health Care in Low back pain patients, consisting in Therapeutic Exercise and Superficial Thermotherapy at home.

Outcomes

Primary Outcome Measures

Severity of Chronic Pain
Graded Chronic Pain Scale

Secondary Outcome Measures

Amount of Physical Activity
International Physical Activity Questionnaire
Kinesiophibia
Tampa Scale of Kinesiophobia
Catastrophism
Pain Catastrophicing Scale
Cardiovascular Risk Factors
American College of Sports Medicine description of 8 Cardiovascular Risk Factors
Anxiety and Depression
Hospital Anxiety and Depression Scale
Low Back Pain Percieved Disability
Roland Morris Disability Questionnaire
Quality of Life
EuroQoL 5D- 5L

Full Information

First Posted
June 29, 2016
Last Updated
July 15, 2016
Sponsor
Universidad Autonoma de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02837653
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Physical Activity
Keywords
cardiovascular Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual Care in Primary Health Care in Low back pain patients, consisting in Therapeutic Exercise and Superficial Thermotherapy at home.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Counselling
Other Intervention Name(s)
Physical Activity Advice
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise for LBP
Intervention Type
Other
Intervention Name(s)
Superficial Thermotherapy
Primary Outcome Measure Information:
Title
Severity of Chronic Pain
Description
Graded Chronic Pain Scale
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Amount of Physical Activity
Description
International Physical Activity Questionnaire
Time Frame
1 month
Title
Kinesiophibia
Description
Tampa Scale of Kinesiophobia
Time Frame
1 month
Title
Catastrophism
Description
Pain Catastrophicing Scale
Time Frame
1 month
Title
Cardiovascular Risk Factors
Description
American College of Sports Medicine description of 8 Cardiovascular Risk Factors
Time Frame
1 month
Title
Anxiety and Depression
Description
Hospital Anxiety and Depression Scale
Time Frame
1 month
Title
Low Back Pain Percieved Disability
Description
Roland Morris Disability Questionnaire
Time Frame
1 month
Title
Quality of Life
Description
EuroQoL 5D- 5L
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CS Entrevías
City
Madrid
ZIP/Postal Code
28053
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23045168
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.
Results Reference
background
PubMed Identifier
16154380
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.
Results Reference
background
PubMed Identifier
22146287
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.
Results Reference
background
PubMed Identifier
3662989
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.
Results Reference
background
PubMed Identifier
6626110
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.
Results Reference
background
PubMed Identifier
19226242
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.
Results Reference
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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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