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

• ClinicalTrials.gov Identifier: NCT02837653
• Recruitment Status: Completed
• First Posted: July 19, 2016
• Last Update Posted: July 19, 2016
• Sponsor: Universidad Autonoma de Madrid
• Information provided by (Responsible Party): Raúl Ferrer-Peña, Universidad Autonoma de Madrid

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).

Condition or disease	Intervention/treatment	Phase
Low Back Pain; Physical Activity	Behavioral: Physical Activity Counselling; Other: Therapeutic Exercise for LBP; Other: Superficial Thermotherapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk
• Study Start Date: January 2016
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Severity of Chronic Pain [ Time Frame: 1 month ]
   Graded Chronic Pain Scale

Secondary Outcome Measures :

1. Amount of Physical Activity [ Time Frame: 1 month ]
   International Physical Activity Questionnaire
2. Kinesiophibia [ Time Frame: 1 month ]
   Tampa Scale of Kinesiophobia
3. Catastrophism [ Time Frame: 1 month ]
   Pain Catastrophicing Scale
4. Cardiovascular Risk Factors [ Time Frame: 1 month ]
   American College of Sports Medicine description of 8 Cardiovascular Risk Factors
5. Anxiety and Depression [ Time Frame: 1 month ]
   Hospital Anxiety and Depression Scale
6. Low Back Pain Percieved Disability [ Time Frame: 1 month ]
   Roland Morris Disability Questionnaire
7. Quality of Life [ Time Frame: 1 month ]
   EuroQoL 5D- 5L

Eligibility Criteria

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

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

Contacts and Locations

Locations

Spain

CS Entrevías

Madrid, Spain, 28053

Sponsors and Collaborators

Universidad Autonoma de Madrid

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Raúl Ferrer-Peña, Principal Investigator, Universidad Autonoma de Madrid
• ClinicalTrials.gov Identifier: NCT02837653
• Other Study ID Numbers: CEULS-PI-108/2016
• First Posted: July 19, 2016
• Last Update Posted: July 19, 2016
• Last Verified: July 2016

Keywords provided by Raúl Ferrer-Peña, Universidad Autonoma de Madrid:

cardiovascular Risk

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations