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

NCT05581784 | Unknown

• 1 other identifier: INeurocienciaDolor02
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 4

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.

Conditions

Cancer Pain

Keywords

Pain Neuroscience education; Cancer pain; Paliative therapy; Neoplasm

Outcome Measures

Primary Outcomes (2)

• Change in Brief Pain Inventory (Impact of pain)

  The BPI or brief pain questionnaire is a self-administered questionnaire that contains two dimensions: one related to the intensity of pain and the impact of pain on the activities of the patient's life. Its use has increased in the evaluation of patients with cancer pain. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. the higher the score, the greater the severity of the pain.

  At baseline and through intervention's completion, 10 weeks

• Change in Visual Analog Scale-Pain (EVA)

  The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.

  At baseline and through intervention's completion, 10 weeks

Secondary Outcomes (8)

• Change in Central Sensitization Inventory Score (CSI)

  At baseline and through intervention's completion, 10 weeks

• Change in Pain Catastrophizing Scale (PCS)

  At baseline and through intervention's completion, 10 weeks

• Change in Tampa Scale for Kinesiophobia (TSK-11)

  At baseline and through intervention's completion, 10 weeks

• Change in Beck Depression Inventory Score

  At baseline and through intervention's completion, 10 weeks

• Change in DN4 neuropathic pain

  At baseline and through intervention's completion, 10 weeks

Other Outcomes (3)

• Change in 6-minute walk test

  At baseline and through intervention's completion, 10 weeks

• Change in grip strength

  At baseline and through intervention's completion, 10 weeks

• Change in Test Get up and Go

  At baseline and through intervention's completion, 10 weeks

Study Arms (2)

Pain neuroscience education.

EXPERIMENTAL

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

Other: Pain neuroscience education

Conventional treatment or Usual Care

OTHER

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

Other: Conventional management or Usual care

Interventions

Pain neuroscience education 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.

Also known as: Explaining Pain, Therapeutic Neuroscience Education

Pain neuroscience education.

Conventional management or Usual care OTHER

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

Also known as: Usual care, Conventional management

Conventional treatment or Usual Care

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Neurociencia Del Dolor: lead
• Universidad Santiago de Cali: collaborator
• Clinica de Occidente: collaborator

Study Sites (4)

Universidad Arturo Prat

Iquique, 1110939, Chile

ACTIVE NOT RECRUITING

Universidad Santiago de Cali

Cali, Valle del Cauca Department, 760033, Colombia

RECRUITING

Clinica de Occidente

Cali, Valle del Cauca Department, 760046, Colombia

RECRUITING

Instituto Neurociencia del Dolor

Puebla City, 72000, Mexico

ACTIVE NOT RECRUITING

Related Publications (4)

• 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.

  PMID: 30606621 BACKGROUND

• 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.

  PMID: 23303884 BACKGROUND

• 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.

  PMID: 20332511 BACKGROUND

• 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.

  PMID: 37758676 DERIVED

Related Links

• Pain definition

MeSH Terms

Conditions

Cancer Pain; Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Leidy Tatiana Ordoñez-Mora, MSC

CONTACT

573159262968; leidy.ordonez01@usc.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Simple (result evaluator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Masking: Simple (result evaluator)

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 17, 2022
• Study Start: February 22, 2023
• Primary Completion: December 22, 2023
• Study Completion: March 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); CL (1); CO (2)