Effectiveness of Coping Strategies on the Control of Chronic Non-Cancer Pain and Quality of Life (CNCP_CopQol)

Summary

* Introduction and objectives: Non-pharmacological interventions in patients with musculoskeletal chronic non-cancer pain (mCNCP) are positioning themselves as an essential pillar in treatment along with pharmacological and interventional treatment. Training the patient in psycho-educational interventions focused on the neuroscience of pain and accompanying them towards a better coping of their disease can decrease the perception of pain and improve their quality of life. A previous pilot study, developed by the researchers about this type of interventions, identified as relevant data an improvement in the quality of life (QoL) of patients with mCNCP with a significant decrease in pharmacological consumption, and a high degree of satisfaction on the part of the user through the analysis of PROMs (patient-reported outcome measures). The main objective of this study is to know the effectiveness in the perception of pain through the Verbal Numerical Rating Scale (VNRS) and in the quality of life through the EuroQol-5D (EQ-5D) questionnaire of a psychoeducational intervention focused on emotional coping strategies, in patients with mCNCP in the Primary Care Centres of Public Health System of Aljarafe-Sevilla Norte Area (Spain). Secondarily, the consumption of health resources associated with mCNCP, the adherence to treatment, the influence of social, emotional, and family variables will be studied by the researchers in the two groups of patients on each telephone assessment.
* Methodology: Prospective, randomized, triple-blind (patient, investigator, and analysis) and controlled clinical trial. Participants with mCNCP in follow-up in Primary Care without clinical control with the treatment scheduled and who agree to participate in the study will be randomized by blocks permuted to receive treatments and standard care (control group) or these same care plus a psychoeducational intervention (experimental group). This intervention consists of an emotional self-regulation training program of four face-to-face sessions of 3 hours each, over a four-week period. The study will include 144 participants (72 for each arm). Patient follow-up will be telephone at the time of inclusion, at month, three, and six months. A descriptive and multivariate analysis will be done with the patients' research data associated with pain or QoL, post-intervention.
* Ethics and dissemination: The study will be carried out following the Helsinki Declaration and is approved by the Committee on Ethics of Research of Virgen Macarena- Virgen del Rocío university hospitals in Seville, Spain (code 1589-N-19). The results of the trial will be published under CONSORT regulations and SPIRIT guideline.

Conditions

• Chronic Pain
• Musculoskeletal Diseases
• Quality of Life
• Pain Measurement

Interventions

BEHAVIORAL

Psychoeducative intervention

This workshop is centred in psychoeducational and training action in emotional self-regulation in a group modality and participatory character, aimed at patients with mCNCP to acquire basic knowledge in: * Neurology and psychoneuroimmunology. * The role of beliefs in our manifestation of the disease. * Body language and modulation of pain perception. * Relaxation body-mind techniques. * Creative visualization for pain management. * Mirror feed-back. The workshop will take place at the Hospital San Juan de Dios del Aljarafe, in four weeks, once a week, three hours each. Until now, the attendance was 24 patients per workshop. After the pandemic, we will reduce to 15 to increase safety distance. We will also conduct a telephone survey of each patient on symptoms of Covid infection in the 24 hours prior to the workshop.

Sponsors & Collaborators

• University of Seville

  collaborator OTHER

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  collaborator OTHER

• Hospital San Juan de Dios del Aljarafe de Sevilla

  lead OTHER

Principal Investigators

• Carmen Sánchez Gutiérrez, MD · Hospital San Juan de Dios del Aljarafe (Seville, Spain)

• Adriana Rivera Sequeiros · Hospital San Juan de Dios del Aljarafe (Seville, Spain)

• Eugenia Gil García · Schooll of Podiatry, Nursing and Physiotherapy. University of Seville. Spain

• Jose Manuel López-Millán Infantes, MD · Hospital Universitario Virgen Macarena

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2022-02-28

Completion

2022-12-31

Countries

• Spain

Study Locations