Effectiveness of the Multicomponent Therapy in Chronic Pain Through The Use of Smartphones (NO+PAIN)

August 12, 2020 updated by: Yolanda Morcillo, Maimónides Biomedical Research Institute of Córdoba

"Effectiveness of Cognitive Behavioral Therapy Against Chronic Pain From a Gender Perspective Through Information Technology in the Southern Health Area of Córdoba

Chronic pain is one of the pathological processes with the greatest impact on the demand of health services. The cost of this process in Spain according to the results is 2.5% of Gross Domestic Product (Breivik, Collett, Ventafridda et al. 2006).Mainly affects women and in it psychological, behavioral and psychological factors converge (Cöster, Kendall, Gerdle et al. 2008). The role of gender as a social determinant of health is known (Stansfeld, 2006).

Multidisciplinary and not only pharmacological intervention stands as a desirable paradigm for addressing this type of health problem, and it is considered necessary to standardize treatment in this regard. Thus, psychological constructs such as the concept of "catastrophization" have demonstrated the relationship between suffering and the displacing experience (Wade, Riddle, Price, Dumenci, 2011) and the psychological framework of Acceptance and Commitment Therapy has also revealed its positive effect. .

The rise of new technologies makes it necessary to give added value to the use of digital mobile devices for its potential contribution to the health care of the population, given its immediacy, widespread use, possibility of interaction and increase of the margin of accessibility to health services.

The present project aims to demonstrate that multidisciplinary and combined intervention of pharmacological therapies with specific psychological therapies along with the use of mobile digital devices can improve the management and evolution of chronic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients received a written invitation from their primary care physician or nurse to a group informational meeting where the principal investigator introduced the program. The study has been completed in a span of three years. People participating in the study were asked to give their informed consent.

To carry out this study, the basic ethical aspects have been guaranteed, approved by the Research Ethics Committee of Córdoba which belongs to the Andalusian Public Health System. The Informed consent was guaranteed by the Research Ethics Committee of Córdoba which belongs to the Andalusian Public Health System In the group meeting, the people who agree to participate in the study will be informed via email, they will be given instructions on how to download the mobile application if they are selected in the intervention group, the treatment will last 6 weeks maximum 8 weeks The three questionnaires will be completed by all study subjects in a maximum time of 10 minutes. Immediately after receiving the two face-to-face sessions.

Then ,the questionnaire will be filled in again by participants at week number (8 weeks maximum after treatment) and three months just after having received the treatment.

The pain management application includes automatic monitoring, skills training, social support, education, goal setting and achievement of 4 components: exercises, psychological well-being, pharmacological and health assets interventions.

Every week participants have a look at digital presentations about every component, doing then 3 activities related to each.This program will be.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14001
        • Yolanda Morcillo Muñoz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The inclusion criteria for patients in this study were: patients ≥18 years of age presenting pain of any location, lasting ≥ 3 months, intensity ≥ 4 on the EVN (Numerical Visual Scale), and with one of the following characteristics: Continuous pain, Intermittent pain ≥ 5 days a week. Not be participating in another research project and with skills for the use of mobile telephony.

Exclusion Criteria:

  • Exclusion criteria included cancer patients, bipolar or psychotic disorder, a history of brain injury, inability to complete study forms due to mental disability or language barrier.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Multimodal pain therapy

The treatment will last 6 weeks maximum 8 weeks. The three questionnaires will be completed by all study subjects in a maximum time of 10 minutes. Immediately after receiving the two face-to-face sessions; 6 weeks after (8 weeks maximum after treatment) and three months just after having completed treatment.

The pain management application includes automatic monitoring, skills training, social support, education, goal setting and achievement of 4 components: exercises, psychological well-being, pharmacological and health assets interventions. Every week participants have a look at digital presentations about every component, doing then 3 activities related to each of them.This program will be.
Other: Multimodal pain therapy
For the elaboration of the contents of the multi-component treatment of the mobile device application (APP), a set of guidelines has been developed for the care of one's own health, based on scientific evidence and adapted to the language of citizens, applying participatory methodology (Loewenson et al. 2014) and consensus, both by professionals (physicians,, nurses, psychologists, pharmacists, social educators and health professionals), and expert patients, who guarantee their validity, allowing the analysis and selection of the interventions that respond to the health problem. This intervention consists in the implementation of a protocol of standard activities of the interactive psychosocial therapy type.
Other Names:
  • NO+PAIN ,SMARPHONE
EXPERIMENTAL: Standardized treatment.
Both groups (control and intervention) received two face-to-face health education sessions led by nurses and physicians, and had access to a non-interactive web page with material for pain management from a self-help approach.
Other: Standardized treatment.
Face-to-face health education sessions led by nurses and physicians, with the possibility to have access to a non-interactive website with pain management materials from a self-help approach.
Other Names:
  • FACE-TO-FACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008),
Time Frame: 6 MONTH
it was used to measure the main outcome variable of the study: catastrophization in pain, which is considered an important prognostic factor in chronic pain in general. The PCS is a 13-item self-administered scale on a 5-point Likert-type scale ranging from 0 (never) to 4 (always). It comprises 3 dimensions: a) rumination; b) magnification, and c) hopelessness. Higher scores indicate higher levels of catastrophism. The Spanish version of the PCS has been shown to have adequate internal consistency, convergent validity, and classificatory value (Cronbach's α = 0.79), test-retest reliability (intraclass correlation coefficient = 0.84), and sensitivity to size change (effect size). > 2), which makes it a good measure, similar to the original scale, so its use is aimed at clinical practice and clinical research (García-Campayo et al., 2008).
6 MONTH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pain Acceptance Questionnaire (CPAQ) (McCracken, Vowles, & Eccleston, 2004). Spanish adaptation by (Balluerka, Gorostiaga, Alonso-Arbiol, & Haranburu, 2007)
Time Frame: 6 MONTH
It was used to measure participation in activities of daily living despite pain and the willingness to experience pain without trying to control, alter or avoid it. It is a 20-item questionnaire that evaluates the acceptance of pain in a 6-point Likert-type format that goes from or (never true) to 6 (always true). The total CPAQ score is the sum of the two subscales. According to (GEISER, 1992), the initial studies carried out in relation to acceptance and adaptation to the CPAQ questionnaire, show adequate internal consistency and expected correlations with measures of physical functioning and psychological distress. After subsequent studies in which its content and dimensionality were evaluated (McCracken et al., 2004), two factors were established, the involvement in activities (Cronbach's α of 0.82) and the openness to pain (Cronbach's α of 0.78). .
6 MONTH

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale of the European Questionnaire on Quality of Life of 5 dimensions. EuroQol 5D (EQ-5D) (Badia, Roset, Montserrat, Herdman, & Segura, 1999)
Time Frame: 6 MONTH
it was used to measure health-related quality of life (HRQL) that can be used both in relatively healthy individuals (general population) and in groups of patients with different pathologies. The individual himself evaluates his state of health, first in severity levels by dimensions (descriptive system) and then on a more general visual analogue scale (VAS) of evaluation. A third element of the EQ-5D is the index of social values obtained for each state of health generated by the instrument. For each dimension of the EQ-5D, severity levels are coded 1 if the answer choice is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems". "The EQ-5D is a simple, valid, and practical measure for use as an outcome variable in both clinical research and health care resource allocation."
6 MONTH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2017

Primary Completion (ACTUAL)

March 30, 2019

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

August 8, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (ACTUAL)

August 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIBIC PI-0447-2017
  • PI-0447-2017 (REGISTRY: Yolanda Morcillo .Principal Investigator)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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