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

NCT ID: NCT02837653

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Low Back Pain Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Physical Activity Counselling

Intervention Type BEHAVIORAL

Therapeutic Exercise for LBP

Intervention Type OTHER

Superficial Thermotherapy

Intervention Type OTHER

Control

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

Group Type ACTIVE_COMPARATOR

Therapeutic Exercise for LBP

Intervention Type OTHER

Superficial Thermotherapy

Intervention Type OTHER

Interventions

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Physical Activity Counselling

Intervention Type BEHAVIORAL

Therapeutic Exercise for LBP

Intervention Type OTHER

Superficial Thermotherapy

Intervention Type OTHER

Other Intervention Names

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Physical Activity Advice

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Raúl Ferrer-Peña

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CS Entrevías

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23045168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16154380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22146287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3662989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6626110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19226242 (View on PubMed)

Other Identifiers

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CEULS-PI-108/2016

Identifier Type: -

Identifier Source: org_study_id

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