Influence of a Educational Internet-based Intervention in Chronic Low Back Pain Patients: A Mixed Methods Approach

NCT02369120 | Completed

• 1 other identifier: ULleida
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about the origin and meaning of pain for developing a biopsychosocial web-based educational intervention. The other aim of this project is to assess the effectiveness of this web-based educational intervention for chronic low back pain patients on pain cognitions, pain intensity, and disability. Methods: Mixed methods design, combining both qualitative and quantitative methodologies. For the qualitative part of this study, the investigators will use qualitative in-depth semi-structured interviews. For the quantitative phase we will use an experimental study design. Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care setting in the city of Lleida. Expected outcomes: The investigators expect to change and modify chronic low back pain patients´ cognition by using our web-site educational intervention, with the further outcome of reducing pain and disability.

Conditions

Low Back Pain

Keywords

patient education; pain cognitions

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  This scale was developed by Huskinson in 1976 as a method of measuring pain intensity. VAS is an easy, simple and reproductible tool that can be used by the same patient in multiple occasions. The scale consists on a 10-cm line with a description on both extremes. In the far left "no pain", and "worst pain ever" in the far right of the scale. For some authors VAS is the most sensitive measure in clinical pain research

  2 weeks

• Fear Avoidance Beliefs

  The FABQ is a self-reported questionnaire that consists of 16 items about the beliefs of LBP patients on the influence that physical activity and work have on their pain. Each item can be scored from 0 (totally agree) to 6 (totally disagree). The Spanish version of the FABQ has demonstrated good reliability

  2 weeks

• Kinesiophobia

  This scale is widely used in pain medicine for assessing pain-related fear. The Spanish format has 11 items, with each scoring ranging from 1 (totally disagree) to 4 (totally agree). The Spanish version of the TSK is easy to use, reliable and valid

  2 weeks

Secondary Outcomes (1)

• Disability

  2 weeks

Study Arms (2)

Normal care by GP

ACTIVE COMPARATOR

Control group: Will follow conventional treatment provided by the family physician in primary care. This treatment is based on the clinical guidelines of the "Institut Català de la Salut" (http://www.gencat.cat/ics/professionals/guies/docs/guia\_lumbalgies.pdf).

Other: Normal care by GP

Educational intervention using a website

EXPERIMENTAL

This group of subjects will be given access to our web-site in where they will find information related to CLBP. This information will be provided in different formats: explanatory video by the author, animated video about the neurophysiology of pain, written format using metaphors, and FAQs. All this information will be based on the information provided by the subjects on QUAL. The aim of this educational intervention is to change patient´s misbeliefs about CLBP with the last outcome of reducing pain intensity, improving function, and reducing disability.

Other: Educational intervention

Interventions

Educational intervention OTHER

The internet platform will provide patients with customized tasks that allow them to use the metaphor of the journey (the narrative as a dynamic of the game) to feel that they manage their own path, which will change negative perceptions into positive perceptions about certain actions. At all times, the patients will be able to choose among different information sources, such as videos about the origin of chronic pain, 3D representations of different neurophysiological processes, and FAQs. Additionally, the patients will be able to contact a specialist in the neurophysiology of pain by email or videoconference. Furthermore, to reinforce patients' motivation and participation, gamification techniques will be implemented.

Educational intervention using a website

Normal care by GP OTHER

Patients will follow GP advice including NSAID medication if needed

Normal care by GP

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of CLBP longer than 6 months.
• Patients between 20-65 years old.
• To be able to read, speak and understand Spanish, Catalan, or English.
• With access to the Internet, a computer or laptop and e-mail address.
• To accept and sign the informed consent.

You may not qualify if:

• \. Any red flag condition:
• Onset age \< 20 or \> 55 years
• Non-mechanical pain (unrelated to time or activity)
• Thoracic pain
• Previous history of carcinoma, steroids, HIV
• Feeling unwell
• Weight loss
• Widespread neurological symptoms
• Structural spinal deformity

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

All Primary care settings

Lleida, 25198, Spain

Location

Related Publications (1)

• Valenzuela-Pascual F, Molina F, Corbi F, Blanco-Blanco J, Gil RM, Soler-Gonzalez J. The influence of a biopsychosocial educational internet-based intervention on pain, dysfunction, quality of life, and pain cognition in chronic low back pain patients in primary care: a mixed methods approach. BMC Med Inform Decis Mak. 2015 Nov 23;15:97. doi: 10.1186/s12911-015-0220-0.

  PMID: 26597937 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Fidel Molina Luque, sociologist

  Universitat de Lleida

  STUDY DIRECTOR

• Rosa Gil Iranzo, Physics

  Universitat de Lleida

  STUDY DIRECTOR

• Francisco Corbi, Sports

  Universitat de Lleida

  STUDY DIRECTOR

• Jorge Soler Gonzalez, MD

  Universitat de Lleida

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2015
• First Posted: February 23, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

ES (1)