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

Cancer Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581784
• Other study ID #: INeurocienciaDolor02
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2023
• Source: Instituto Neurociencia Del Dolor
• Contact: Leidy Tatiana Ordoñez-Mora, MSC
• Phone: 573159262968
• Email: leidy.ordonez01[@]usc.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• 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.
• Conventional management or Usual care
This group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention.

Locations

Country	Name	City	State
Chile	Universidad Arturo Prat	Iquique
Colombia	Clinica de Occidente	Cali	Valle
Colombia	Universidad Santiago de Cali	Cali	Valle
Mexico	Instituto Neurociencia del Dolor	Puebla

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Neurociencia Del Dolor	Clinica de Occidente, Universidad Santiago de Cali

Countries where clinical trial is conducted

Chile,  Colombia,  Mexico, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in 6-minute walk test	It is performed to determine exercise tolerance and specify functional status. This evaluates the number of meters traveled during the last 6 minutes.	At baseline and through intervention's completion, 10 weeks
Other	Change in grip strength	It is a marker of nutritional status and a marker of morbidity and mortality of the pathology. It will be measured with a dynamometer to establish the grip strength value in kilograms.	At baseline and through intervention's completion, 10 weeks
Other	Change in Test Get up and Go	This test has been developed, finding that it has been a predictor of falls and as a measure of functional capacity. n this test, the participant starts in a chair, stands up, runs three meters, and sits down again. The time of the execution of the test is taken.	At baseline and through intervention's completion, 10 weeks
Primary	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
Primary	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	Change in Central Sensitization Inventory Score (CSI)	Central Sensitization Inventory (CSI) is a scale used to detect patients with symptoms associated with central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension type headache, migraine.; The Central Sensitization Inventory (CSI) consists of two parts: Part A consists of 25 questions about central sensitization syndrome (CNS) symptoms; Section B examines the patient's condition of being diagnosed with certain CNS diseases or CNS related diseases such as anxiety and depression.; The patient answers 25 questions in section A with a score between 0 and 4. The total score will be between 0-100. Results above 40 points indicate central sensitization.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in Pain Catastrophizing Scale (PCS)	The PCS is measured with a self-administered questionnaire. Is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in Tampa Scale for Kinesiophobia (TSK-11)	TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in Beck Depression Inventory Score	Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.It contains 21 categories to measure physical, emotional, cognitive and motivational symptoms such as hopelessness, irritability, guilt, feeling of punishment, fatigue, and weight loss in each depression, and each category is scored between 0-3. The patient is asked to mark the most appropriate one for the four options in each category. Scoring progressively increases from the absence of symptoms to severe symptoms. 0-10 points: No depression, 11-17 points: Mild depression, 18-23 points: Moderate depression, 24 and above points: Severe depression.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in DN4 neuropathic pain	We will work with the DN4 scale that evaluates 4 questions with a possibility of being qualified up to 10 points to determine the presence of neuropathic pain.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in Moca test Cognitive function	It is made up of 19 items and eight cognitive domains that assess skills such as visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. a maximum score of 30, with the cut-off points for cognitive impairment being 25/26.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in EORTC QLQ C-30 Quality of life	has been defined as the way in which the individual perceives his/her place in life, The standard model consists of 14 domains and an empirical solution with five domains (physical, psychological, frailty, socioeconomic, and global score). This widely used questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social function), a global quality of life (QoL) scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six individual. items (loss of appetite, diarrhea, dyspnea, constipation, insomnia, economic impact). For the functional and global quality of life scales, a higher score indicates better health. For the symptom scales, a higher score indicates a higher symptom burden.	At baseline and through intervention's completion, 10 weeks
Secondary	Change in Sleep quality Pittsburgh Sleep Quality Index	This is one of the most reliable tests to define the quality of sleep and its disorders. It contains a total of 19 questions, grouped into 10 questions. The questions are combined to form seven areas with their corresponding score, each one of which shows a range between 0 and 3 points.	At baseline and through intervention's completion, 10 weeks

External Links

•   Pain definition