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

Not Applicable

Completed

• Conditions: Low Back Pain; Physical Activity
• Interventions: Behavioral: Physical Activity Counselling; Other: Therapeutic Exercise for LBP; Other: Superficial Thermotherapy

• Registration Number: NCT02837653
• Lead Sponsor: Universidad Autonoma de Madrid

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-29
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Study First Posted: 2016-07-19
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Therapeutic Exercise for LBP	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
Control	Therapeutic Exercise for LBP	Usual Care in Primary Health Care in Low back pain patients, consisting in Therapeutic Exercise and Superficial Thermotherapy at home.
Experimental	Physical Activity Counselling	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
Experimental	Superficial Thermotherapy	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
Control	Superficial Thermotherapy	Usual Care in Primary Health Care in Low back pain patients, consisting in Therapeutic Exercise and Superficial Thermotherapy at home.

Primary Outcome Measures

Name	Time	Method
Severity of Chronic Pain	1 month	Graded Chronic Pain Scale

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression	1 month	Hospital Anxiety and Depression Scale
Quality of Life	1 month	EuroQoL 5D- 5L
Amount of Physical Activity	1 month	International Physical Activity Questionnaire
Catastrophism	1 month	Pain Catastrophicing Scale
Kinesiophibia	1 month	Tampa Scale of Kinesiophobia
Cardiovascular Risk Factors	1 month	American College of Sports Medicine description of 8 Cardiovascular Risk Factors
Low Back Pain Percieved Disability	1 month	Roland Morris Disability Questionnaire

Trial Locations

Locations (1)

CS Entrevías; 🇪🇸 Madrid, Spain