Effectiveness of the Multicomponent Therapy in Chronic Pain Through The Use of Smartphones

NCT04509154 | Completed

• 2 other identifiers: IMIBIC PI-0447-2017PI-0447-2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catastrophization; Chronic Pain; Pain, Chronic; Cognitive Therapy; Smartphones; Acceptance, Social

Outcome Measures

Primary Outcomes (1)

• The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008),

  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 Outcomes (1)

• The Pain Acceptance Questionnaire (CPAQ) (McCracken, Vowles, & Eccleston, 2004). Spanish adaptation by (Balluerka, Gorostiaga, Alonso-Arbiol, & Haranburu, 2007)

  6 MONTH

Other Outcomes (1)

• Scale of the European Questionnaire on Quality of Life of 5 dimensions. EuroQol 5D (EQ-5D) (Badia, Roset, Montserrat, Herdman, & Segura, 1999)

  6 MONTH

Study Arms (2)

Multimodal pain therapy

EXPERIMENTAL

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

Standardized treatment.

EXPERIMENTAL

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.

Interventions

Multimodal pain therapy OTHER

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.

Also known as: NO+PAIN ,SMARPHONE

Multimodal pain therapy

Standardized treatment. OTHER

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.

Also known as: FACE-TO-FACE

Standardized treatment.

Eligibility Criteria

• Gender Eligibility Details: The study population includes residents in the municipalities belonging to the public health area included in the User Database (BDU) of the Andalusian Health Service. The global population in 2019 was 261,563 inhabitants. The sample was drawn from the database of the system used by the Andalusian Health Service to support the electronic medical record "Diraya", identifying patients with the inclusion criteria, attended by primary care doctors and nurses. As a result of the June 2019 consultation, a total of 1,794 people were obtained, of which 1,498 were women and 296 were men.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Yolanda Morcillo Muñoz

Córdoba, 14001, Spain

Location

Related Publications (18)

• Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.

  PMID: 21565446 RESULT

• Deckert S, Kaiser U, Kopkow C, Trautmann F, Sabatowski R, Schmitt J. A systematic review of the outcomes reported in multimodal pain therapy for chronic pain. Eur J Pain. 2016 Jan;20(1):51-63. doi: 10.1002/ejp.721. Epub 2015 May 29.

  PMID: 26031689 RESULT

• Finset, A., Butow, P., Zimmermann Peter Salmon Peter Schulz, C., Steele Europe Robert Hulsman, D., Hatem, D., Rider Europe Shmuel Reis, E., … Florence van Zuuren, K. (n.d.). Official Journal of The European Association for Communication in Healthcare The American Academy on Communication in Healthcare EDITOR-IN-CHIEF Medical Education Editors Americas Reflective Practice Editors Americas. Retrieved from http://www.elsevier.com/

  RESULT

• Garcia-Palacios A, Herrero R, Belmonte MA, Castilla D, Guixeres J, Molinari G, Banos RM. Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study. Eur J Pain. 2014 Jul;18(6):862-72. doi: 10.1002/j.1532-2149.2013.00425.x. Epub 2013 Nov 22.

  PMID: 24921074 RESULT

• Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. J Med Internet Res. 2013 Mar 28;15(3):e72. doi: 10.2196/jmir.2442.

  PMID: 23538392 RESULT

• Kristjansdottir OB, Fors EA, Eide E, Finset A, van Dulmen S, Wigers SH, Eide H. Written online situational feedback via mobile phone to support self-management of chronic widespread pain: a usability study of a Web-based intervention. BMC Musculoskelet Disord. 2011 Feb 25;12:51. doi: 10.1186/1471-2474-12-51.

  PMID: 21352516 RESULT

• Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.

  PMID: 20650691 RESULT

• Martinez-Calderon J, Jensen MP, Morales-Asencio JM, Luque-Suarez A. Pain Catastrophizing and Function In Individuals With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Mar;35(3):279-293. doi: 10.1097/AJP.0000000000000676.

  PMID: 30664551 RESULT

• SIGN 136 • Management of chronic pain. (2013). Retrieved from www.sign.ac.uk/pdf/sign50eqia.pdf. Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and Validation. In Psychological Assessment (Vol. 7).

  RESULT

• Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.

  PMID: 26818413 RESULT

• Wildevuur SE, Simonse LW. Information and communication technology-enabled person-centered care for the "big five" chronic conditions: scoping review. J Med Internet Res. 2015 Mar 27;17(3):e77. doi: 10.2196/jmir.3687.

  PMID: 25831199 RESULT

• Yadavaia JE, Hayes SC, Vilardaga R. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial. J Contextual Behav Sci. 2014 Oct 1;3(4):248-257. doi: 10.1016/j.jcbs.2014.09.002.

  PMID: 25506545 RESULT

• Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and Validation. In Psychological Assessment (Vol. 7).

  RESULT

• Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.

  PMID: 19007576 RESULT

• Balluerka, N., Gorostiaga, A., Alonso-Arbiol, I., & Haranburu, M. (2007). Animal Assisted Therapy View project ANOTHE View project. Retrieved from www.psicothema.com

  RESULT

• McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004 Jan;107(1-2):159-66. doi: 10.1016/j.pain.2003.10.012.

  PMID: 14715402 RESULT

• Badia X, Roset M, Montserrat S, Herdman M, Segura A. [The Spanish version of EuroQol: a description and its applications. European Quality of Life scale]. Med Clin (Barc). 1999;112 Suppl 1:79-85. Spanish.

  PMID: 10618804 RESULT

• Morcillo-Munoz Y, Sanchez-Guarnido AJ, Calzon-Fernandez S, Baena-Parejo I. Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial. J Med Internet Res. 2022 May 11;24(5):e36114. doi: 10.2196/36114.

  PMID: 35373776 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, a distribution by blocks of size four was used, in which the only criterion for stratification was the reference Health Center of the patient in question. Therefore, in order to randomize a patient, the existing button on the recruitment form for this study, hosted on the REDCap platform of the Maimonides Institute for Biomedical Research in Córdoba, was clicked. (IMIBIC). The data was transferred to the electronic notebook: the Data Entry Manager. The statistician, principal investigator, and study collaborators who evaluated the respondents were not involved in patient recruitment and were blinded to group allocation. Recruiters were not blinded to be available throughout the study to ask and answer participants' treatment questions.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effectiveness of Cognitive Behavioral Therapy Before Chronic Pain From a Gender Perspective Through Information Technology in the South Sanitary Area of Córdoba

Model Details: The design is based on a parallel group controlled randomized clinical trial experimental study (Kristjánsdóttir et al., 2011). "Block" randomization is used to ensure similar numbers in each group and by phase.

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: October 30, 2017
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

ES (1)