Clinical trial NCT05581784: Effectiveness of a Pain Neuroscience Education Program in Adults With Cancer Pain
Official title: The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Keywords: Pain Neuroscience education
Cancer pain
Paliative therapy
Neoplasm
Lead sponsor: Instituto Neurociencia Del Dolor
Sponsor class: OTHER
Collaborators: name: Universidad Santiago de Cali
name: Clinica de Occidente
First posted: 2022-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Masking: Simple (result evaluator)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Brief Pain Inventory (Impact of pain)
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Visual Analog Scale-Pain (EVA)
timeFrame: At baseline and through intervention's completion, 10 weeks
Secondary outcomes:
measure: Change in Central Sensitization Inventory Score (CSI)
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Beck Depression Inventory Score
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in DN4 neuropathic pain
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Moca test Cognitive function
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in EORTC QLQ C-30 Quality of life
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Sleep quality Pittsburgh Sleep Quality Index
timeFrame: At baseline and through intervention's completion, 10 weeks
Other outcomes:
measure: Change in 6-minute walk test
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in grip strength
timeFrame: At baseline and through intervention's completion, 10 weeks
measure: Change in Test Get up and Go
timeFrame: At baseline and through intervention's completion, 10 weeks
Locations:
city: Iquique
country: Chile
facility: Universidad Arturo Prat
city: Cali
country: Colombia
facility: Universidad Santiago de Cali
state: Valle
city: Cali
country: Colombia
facility: Clinica de Occidente
state: Valle
city: Puebla
country: Mexico
facility: Instituto Neurociencia del Dolor
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.