NCT05581784

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

The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Instituto Neurociencia Del Dolor · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
OTHER	Conventional management or Usual care	This group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention.

Timeline

• Start date: 2023-02-22
• Primary completion: 2023-12-22
• Completion: 2024-03-01
• First posted: 2022-10-17
• Last updated: 2023-06-15

Locations

4 sites across 3 countries: Chile, Colombia, Mexico