Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies

NCT06440668 | Not Yet Recruiting

• 1 other identifier: 2-2024
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled clinical trial will be conducted, involving a psychoeducational activity as the intervention. There will be a control group of patients with non-cancer chronic pain who will continue their usual treatment. The trial will end after 3 months. Pain, well-being, medication management, mood, self-esteem, and quality of life will be compared just before starting the workshop with the status at the end of the workshop (one month later) to assess the immediate effect, and three months later to evaluate the medium-term effect. These measurements will be taken in both the control and intervention groups. Additionally, for the intervention group, a follow-up will be conducted six months after the workshop ends to assess the long-term effect duration. This study does not allow blinding of patients or professionals conducting the intervention, but the person analyzing the data to compare the effect produced in the control and intervention groups will be blinded. Therefore, it is an observer-blind evaluation.

Conditions

Chronic Pain Syndrome; Sensitization, Central; Quality of Life; Patient Empowerment

Keywords

Chronic Pain Syndrome; Sensitization, Central; Quality of Life; Patient Empowerment

Outcome Measures

Primary Outcomes (8)

• Pain last week

  Pain measured with the "visual analogue scale" (scale: 0-10)

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Analgesic regimen

  self-assessment at the end of the workshop on whether they have replaced a higher-tier analgesic with a lower one, decreased the dosage, reduced the frequency, or stopped taking analgesics or anxiolytics/antidepressants.

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Well-being

  Numerical visual scale from 0 (minimum) to 10 (maximum). Higher scores indicate greater well-being.

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Self-esteem

  Rosenberg Self-esteem Scale, ranging from 9 (minimum) to 36 (maximum).Higher scores indicate greater Self-esteem

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Anxiety and Depression

  Hospital Anxiety and Depression Scale (HADS). It consists of 14 items with two subscales (anxiety and depression), each with scores from 0 to 3. Cut-off points: \<8 normal, 8-10 possible cases, and \>10 for cases in both subscales.

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Resilience

  Brief Resilience Scale (BRS). Scale from 6 (minimum) to 30 (maximum). Higher scores indicate greater resilience.

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Health-related quality of life

  Measured with the EuroQol-5D questionnaire. Scale from 0 to 1 (maximum) (with the possibility of negative values). Higher scores indicate greater health-related quality of life.

  4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

• Number of emergency episodes and outpatient visits

  The number of emergency episodes and outpatient visits for pain or associated symptoms (anxiety, depression, insomnia) will be quantified, both in primary care (at their health center) and hospitalized.

  3 measurements: The scale will be administered just before starting the workshop, at 3 months, and at 6 months (this only in the intervention group).

Secondary Outcomes (2)

• Satisfaction with the workshop

  1 measurement: The scale will be administered just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group).

• Improving habits

  2 measurements: In the 3rd session and just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group).

Study Arms (2)

Workshop

EXPERIMENTAL

Psychoeducational and self-care training, pain management, and emotional control, conducted in groups and aimed at patients with non-cancer chronic pain. Therapies applied: relaxation, meditation, cognitive-behavioral therapy, acceptance and commitment therapy, coaching, healthy eating, physical exercise, improving self-esteem, forgiveness technique. This group starts and successfully completes the workshop. A patient is considered to have successfully completed if they: Attend at least 4 out of the 5 sessions; complete all the initial documentation, at the end of the workshop, and at the 3-month mark; perform daily tracking of the 3 mandatory activities throughout the duration of the workshop.

Behavioral: Chronic Pain Management Workshop with Non-Pharmacological Therapies

Traditional treatment

NO INTERVENTION

This group meets the inclusion criteria but does not participate in the workshop. They complete all documentation at the beginning, at one month, and at three months. These patients will continue with the usual treatment prescribed by their doctor.

Interventions

Chronic Pain Management Workshop with Non-Pharmacological Therapies BEHAVIORAL

1st Session: Welcome. Expectations. Pathophysiological mechanism of pain. Influence of emotions on pain intensity. Activities: My limiting beliefs; Affirmations in front of the mirror; Mental analgesia. / 2nd: Pain and its impact on the patient's life. Forgiveness and self-forgiveness. Ho'oponopono technique. Self-esteem. Activities: Labels that limit us; Reading "When I Loved Myself for Real"; Self-healing meditation; Life purpose. / 3rd: Tips to slow down aging. Promotion of healthy habits; Metta meditation; Motivation for change. / 4th: Active participation in my own healing. How to face illness. Creative visualization. Activity:Energy wheel. / 5th: Review of the tools. Resolving doubts. Workshop evaluation and scales. Guide with the tools presented. Activities: Final farewell. / At the end of each session, the homework assignments are explained, and at the beginning of the next, they are reviewed. Sessions 2, 3, 4 5: Experience of a previous workshop patient.

Workshop

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older,
• Residing in the areas served by HSJDA,
• With non-cancer chronic pain already diagnosed and treated for at least 6 months but not relieved by the usual treatment,
• Who have explicitly and in writing expressed their desire to participate in the workshops and the study through the Informed Consent document,
• And who complete the initial documentation necessary for their evaluation.

You may not qualify if:

• Patients in the diagnostic phase,
• Patients with pain exclusively associated with cancer pathology,
• Patients with a life expectancy of less than one year,
• Patients with severe cognitive or mental illnesses that prevent them from understanding both the content of the workshops and the measurement instruments.

Sponsors & Collaborators

• Hospital San Juan de Dios del Aljarafe de Sevilla: lead

Study Sites (1)

María Victoria RUIZ ROMERO

Bollullos de la Mitación, Sevilla, 41110, Spain

Location

Related Publications (4)

• Ruiz Romero MV, Lobato Parra E, Porrua Del Saz A, Martinez Monrobe MB, Pereira Delgado CM, Gomez Hernandez MB. [Management of chronic non-oncologic pain by multicomponent programs using non-pharmacologic therapies: A systematic review of the literature]. J Healthc Qual Res. 2024 May-Jun;39(3):168-187. doi: 10.1016/j.jhqr.2024.02.004. Epub 2024 Mar 30. Spanish.

  PMID: 38556371 BACKGROUND

• Ruiz Romer MV, Porrua Del Saz A, Gomez Hernandez MB, Lobato Parra E, Soler Jimenez A, Pereira Delgado C. [Impact of a multicomponent program with nonpharmacological therapies for patients with chronic pain]. J Healthc Qual Res. 2024 Mar-Apr;39(2):109-119. doi: 10.1016/j.jhqr.2024.01.005. Epub 2024 Feb 23. Spanish.

  PMID: 38402091 BACKGROUND

• Ruiz Romero MV, Lopez Tarrida AC, Porrua Del Saz A, Gomez Hernandez MB, Martinez Monrobe MB, Sanchez Villar E, Cruz Valero C, Pereira Delgado C. [Efectividad de una intervencion multimodal para la mejora de la atencion al dolor cronico.]. Rev Esp Salud Publica. 2023 Sep 6;97:e202309071. Spanish.

  PMID: 37921370 BACKGROUND

• Ruiz-Romero MV, Guerra-Martin MD, Alvarez-Tellado L, Sanchez-Villar E, Arroyo-Rodriguez A, Sanchez-Gutierrez MC. [Non-drug treatments for chronic non-malignant pain]. An Sist Sanit Navar. 2022 Aug 30;45(2):e1011. doi: 10.23938/ASSN.1011. No abstract available. Spanish.

  PMID: 36040235 BACKGROUND

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The statistician who analyse the data is unaware of the group to which each patient belonged.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled clinical trial

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 4, 2024
• Study Start: June 10, 2024
• Primary Completion: May 31, 2025
• Study Completion: October 31, 2025
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)