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

NCT02837653 | Completed

• 1 other identifier: CEULS-PI-108/2016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain; Physical Activity

Keywords

cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Severity of Chronic Pain

  Graded Chronic Pain Scale

  1 month

Secondary Outcomes (7)

• Amount of Physical Activity

  1 month

• Kinesiophibia

  1 month

• Catastrophism

  1 month

• Cardiovascular Risk Factors

  1 month

• Anxiety and Depression

  1 month

Study Arms (2)

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: Therapeutic Exercise for LBP; Other: Superficial Thermotherapy

Control

ACTIVE COMPARATOR

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

Interventions

Physical Activity Counselling BEHAVIORAL

Also known as: Physical Activity Advice

Experimental

Therapeutic Exercise for LBP OTHER

Control; Experimental

Superficial Thermotherapy OTHER

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with low back pain more than 3 months
• Age over 18 years old
• Low or Medium Cardiovascular Risk

You may not qualify if:

• Cardiovascular Risk Factors ≥ 5
• Quirurgic procedures at spine last 10 years
• Past of Cancer, or Fibromialgia

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

CS Entrevías

Madrid, Madrid, 28053, Spain

Location

Related Publications (6)

• 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.

  PMID: 23045168 BACKGROUND

• 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.

  PMID: 16154380 BACKGROUND

• 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.

  PMID: 22146287 BACKGROUND

• 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.

  PMID: 3662989 BACKGROUND

• 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.

  PMID: 6626110 BACKGROUND

• 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.

  PMID: 19226242 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 19, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

ES (1)