Effectiveness of a Pain Neuroscience Education Program in Adults With Cancer Pain

NCT ID: NCT05581784

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2024-03-01

Brief Summary

IASP defines "pain" as "an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage". In some patients, pain is one of the reasons they initially consult a doctor and will be strongly related to cancer itself, is connected to receiving the cancer diagnosis, and therefore may become an uncertain threat of disease recurrence in cancer survivors. Neuropathic pain is the most prevalent type of pain, but a mixed type of pain is also common, reflecting the complexity of the pain experience. There is increasing evidence in oncology that quality of life and survival are linked to early and effective palliative care, including pain management. Although improvements have been seen, undertreatment of pain remains a problem in a significant subset of cancer patients. Regarding the interventional options in cancer pain, multiple possibilities range from pharmacological modulation, the use of modalities or physical means, as well as the practice of physical exercise as a mechanism of pain modulation, which has been established according to the background grade of recommendation. Regarding education in neuroscience, this has gained momentum in chronic pain since previous interventions have generated recommendations to include neurocognitive interventions in pain processes. Therefore, it seeks to determine the effectiveness of a neuroscience education program compared to conventional treatment in adults with cancer pain in biopsychosocial variables.

Detailed Description

A parallel group randomized controlled clinical trial will be conducted during the months of November 2022 to December 2023. The proposed research will be a quantitative experimental design type controlled clinical trial following the SPIRIT guidelines for clinical trial protocols and CONSORT for the execution of clinical trials.

A total of 80 patients, where 40 will be assigned to (PNE) and 40 to conventional management. experimental group: based on education in neuroscience of pain for 9 sessions in a period of 10 weeks. Work will be done to prepare the content for an adapted and illustrated guide as a complementary material for patients. An expert judgment test will be carried out to validate the content of the material. Each patient must complete at least 8 sessions to comply with the protocol. These sessions will be personalized and will include the guide as complementary material for each session. This group remains with pharmacological treatment and the usual guidelines given by the doctor. Results will be assessed at baseline (t1) and at week 10 (t2). Written informed consent will be obtained from all participants prior to their participation.

Conditions

Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain neuroscience education.

This consists of generating elements from neurobiology and neurophysiology for the understanding of pain from the development of metaphors.

Group Type: EXPERIMENTAL

Pain neuroscience education

Intervention Type: OTHER

PNE sessions will be led by an experienced physical therapist certified in PNE in 35-minute face-to-face group sessions. Here elements of the neurophysiology of pain are addressed, as well as the different psychosocial dimensions that influence it. The distribution of themes will be carried out as follows:

Week One: Coping with Pain. Week 2: Pain and Cognition Week 3: Your security system Week 4: Altered Alarm System (extra sensitive). Week 5: The defense system is in distress. Week 6: Fatigue, anxiety, and stress Week 7: Current Models of Treatment Week 8: Achievements and goals Week 9: Pain emphasis and differentiation This group remains with pharmacological treatment and the usual guidelines given by the doctor.

Conventional treatment or Usual Care

Pharmacological treatment and indications estimated by a specialist in palliative care and pain.

Group Type: OTHER

Conventional management or Usual care

Intervention Type: OTHER

This group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention.

Interventions

Pain neuroscience education

PNE sessions will be led by an experienced physical therapist certified in PNE in 35-minute face-to-face group sessions. Here elements of the neurophysiology of pain are addressed, as well as the different psychosocial dimensions that influence it. The distribution of themes will be carried out as follows:

Week One: Coping with Pain. Week 2: Pain and Cognition Week 3: Your security system Week 4: Altered Alarm System (extra sensitive). Week 5: The defense system is in distress. Week 6: Fatigue, anxiety, and stress Week 7: Current Models of Treatment Week 8: Achievements and goals Week 9: Pain emphasis and differentiation This group remains with pharmacological treatment and the usual guidelines given by the doctor.

Intervention Type: OTHER

Conventional management or Usual care

This group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention.

Intervention Type: OTHER

Other Intervention Names

Explaining Pain; Therapeutic Neuroscience Education; Usual care; Conventional management

Eligibility Criteria

Inclusion Criteria

• Patients with a life expectancy of more than three months (Karnofski Scales (KPS), Eastern Cooperative Oncology Group Scale (ECOG), survival prognosis PAP score, Palliative Prognosis Index PPI).
• Acceptance of informed consent.
• Educational level (high school diploma).
• No pain hospitalizations in the previous month
• Capable of establishing a team communication process
• at least 21 points on the MOCA scale for preserved cognitive function
• Understanding of the Spanish language.

Exclusion Criteria

• Surgery scheduled within the next three months
• Visual and auditory sensory system deficiency (deafness or blindness).
• The presence of a recent traumatic injury
• Atrial or ventricular arrhythmias that are uncontrolled.
• Aortic aneurysm dissection
• Aortic stenosis severe
• Endocarditis or pericarditis that is acute
• Uncontrollable hypertension
• Thromboembolic disease, acute.
• Acute severe heart failure
• Acute severe respiratory failure
• Fracture within the last month

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Santiago de Cali

OTHER

Sponsor Role: collaborator

Clinica de Occidente

UNKNOWN

Sponsor Role: collaborator

Instituto Neurociencia Del Dolor

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Arturo Prat

Iquique, , Chile

Site Status: ACTIVE_NOT_RECRUITING

Universidad Santiago de Cali

Cali, Valle del Cauca Department, Colombia

Site Status: RECRUITING

Clinica de Occidente

Cali, Valle del Cauca Department, Colombia

Site Status: RECRUITING

Instituto Neurociencia del Dolor

Puebla City, , Mexico

Site Status: ACTIVE_NOT_RECRUITING

Countries

Chile; Colombia; Mexico

Central Contacts

Leidy Tatiana Ordoñez-Mora, MSC

Role: CONTACT

leidy.ordonez01@usc.edu.co

573159262968

Facility Contacts

Leidy Tatiana Ordoñez-Mora

Role: primary

tatiana.ormora@gmail.com

573159262968

Juan Carlos Avila Valencia, MSC

Role: primary

rhcardiopulmonar09@gmail.com

573013369979

References

Nijs J, Wijma AJ, Leysen L, Pas R, Willaert W, Hoelen W, Ickmans K, Wilgen CPV. Explaining pain following cancer: a practical guide for clinicians. Braz J Phys Ther. 2019 Sep-Oct;23(5):367-377. doi: 10.1016/j.bjpt.2018.12.003. Epub 2018 Dec 21.

Reference Type: BACKGROUND

PMID: 30606621 (View on PubMed)

Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

Reference Type: BACKGROUND

PMID: 23303884 (View on PubMed)

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.

Reference Type: BACKGROUND

PMID: 20332511 (View on PubMed)

Ordonez-Mora LT, Rosero ID, Morales-Osorio MA, Guil R, Quintero Jordan G, Agudelo Jimenez JA, Gonzalez-Ruiz K, Avila-Valencia JC. NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain. BMJ Open. 2023 Sep 27;13(9):e071493. doi: 10.1136/bmjopen-2022-071493.

Reference Type: DERIVED

PMID: 37758676 (View on PubMed)

Related Links

https://www.iasp-pain.org/

Pain definition

Other Identifiers

INeurocienciaDolor02

Identifier Type: -

Identifier Source: org_study_id