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

NCT04696107 | Unknown DMC

• 1 other identifier: HSJDA-20.1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Non-Cancer Pain; Quality of life; Pain control; Coping; Patient education; Psychoeducative intervention

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Pain perception

  It is measured by Verbal Numerical Rate Scale (NVRS). The NVRS will be used for its simplicity and reproducibility and in patients without cognitive impairment has a compliance close to 100%. Quantitative result by 0 to 10, where 0 is painless and 10 is as much pain as possible.

  Baseline and six months.

• Change from Baseline Quality of life

  It is measured by the EuroQol-5D questionnaire (EQ-5D). The EQ-5D is an instrument which evaluates the generic QoL with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit an index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). We have used this questionnaire because its analysis of internal consistency shows high Cronbach coefficients.

  Baseline and six months.

Secondary Outcomes (25)

• Gender.

  Baseline.

• Age.

  Baseline.

• Weight.

  Baseline.

• Height.

  Baseline.

• Body Mass Index (BMI).

  Baseline.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Standard pharmacological treatment aimed at controlling mCNCP with four-week face to face psychoeducational intervention.

Behavioral: Psychoeducative intervention

Control Group

NO INTERVENTION

Standard pharmacological treatment aimed at controlling mCNCP without psychoeducational intervention.

Interventions

Psychoeducative intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• People over the age of 18.
• People with mCNCP served for this reason in the Primary Care Centres depend on Hospital San Juan de Dios del Aljarafe, who follow regular specific treatment on the WHO analgesic scale and who have accepted, after information and informed consent signature, their participation in this study.
• Able to read and write Spanish.

You may not qualify if:

• Patients who have received interventional analgesic treatment in the year for the current disease.
• Have followed program or maintain out-of-hospital therapy similar to the one this study focuses on.
• Have had surgery or been on a waiting list during the study.
• Severe or decompensated systemic disease.
• Active cancer disease.
• Psychiatric pathology, epilepsy or cognitive impairment.
• Abuse drug addiction.
• Accidents or new Injuries that may increase the perception of pain during the study.
• Labor litigation due to pain.
• Language barrier.
• LOSS CRITERIA:
• Voluntary abandonment of the study.
• Absence of one or more workshop sessions
• Partial or complete loss of telephone follow-up.
• Incomplete data collection.

Sponsors & Collaborators

• Hospital San Juan de Dios del Aljarafe de Sevilla: lead
• University of Seville: collaborator
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator

Study Sites (1)

Hospital San Juan de Dios del Aljarafe

Bormujos, Sevilla, 41930, Spain

Location

Related Publications (23)

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MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Diseases; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Carmen Sánchez Gutiérrez, MD

  Hospital San Juan de Dios del Aljarafe (Seville, Spain)

  PRINCIPAL INVESTIGATOR

• Adriana Rivera Sequeiros

  Hospital San Juan de Dios del Aljarafe (Seville, Spain)

  STUDY CHAIR

• Eugenia Gil García

  Schooll of Podiatry, Nursing and Physiotherapy. University of Seville. Spain

  STUDY DIRECTOR

• Jose Manuel López-Millán Infantes, MD

  Hospital Universitario Virgen Macarena

  STUDY DIRECTOR

Central Study Contacts

Adriana Rivera Sequeiros

CONTACT

+34 655490655; adriana.rivera@sjd.es

Carmen Sánchez Gutiérrez, MD

CONTACT

+34 650227613; mari1959@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After randomization and assignment to each arm, the masking will be triple ( researcher, evaluator of results, participant): * Researchers: All the professionals who participate in the study will only do so in a single specific stage and will be blinded to the assignment and development of others. * Evaluators of results: The results will be analyzed by an independent statistical professional and the evaluation of the response will be carried out by researchers who do not know the group to which each patient belongs. * Participant: Patients will be blinded for up to six months of follow-up. Then they will know the group to which they belong and will be invited to do the workshop if they have belonged to the control group. We don't believe that it is possible that a patient emergency unmasking will be required due to secondary effects, even so, the Patient Safety Committee will inform of any incident.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A triple blinded, Randomized, Parallel-Group Clinical Trial. 1. Patients who meet the inclusion criteria are informed, voluntarily agree to participate and give signed consent at their Primary Care Center, will be included in the study. In the Investigation Unit of the Hospital San Juan De Dios del Aljarafe they will be anonymised using a table where their medical history number will be assigned an order number, which will serve as identification. They will also be randomized by permuted blocks. 2. Telephone surveys: A professional of the Hospital San Juan de Dios del Aljarafe will be responsible for taking all questionnaires by telephone at the beginning, per month, three months and six months of inclusion for each patient. 3. Psychoeducational intervention: The two professionals who teach the workshops are hospital workers with training in Pain Neuroscience and Coaching. 4. Data analysis: by a biostatistics expert. No professional can access the rest of the information of the study.

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: April 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2022
• Last Updated: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Registration and consent will be available from the beginning of the study on ClinicalTrials.gov. The results will be published once the study is finished (2 years)
• Access Criteria: ClinicalTrials.gov registry

Locations

ES (1)