NCT07287501 Efficacy of Pain Science Education Combined With Exercise in Older Adults With Chronic Pain

Trial Parameters

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Brief Summary

As people live longer, long-term pain becomes more common in old age. This type of pain can greatly affect quality of life, reduce independence in daily activities, and diminish overall well-being. This study is part of a project called PReGe, which aims to help older adults age actively and healthily through preventive physiotherapy. The goal is to determine whether a combination of adapted exercise and education about how pain works can help improve the lives of those who suffer from it. The study is supported by the City Council of Salamanca and the Faculty of Nursing and Physiotherapy, and it is carried out in collaboration with the Doctoral Program in Health, Disability, Dependency, and Well-being at the University of Salamanca. The purpose of this study is to determine whether a program that combines physical exercise with educational sessions about pain is more effective for adults over 65 years of age with chronic pain, compared to doing exercise alone. The study aims to find out whether this program improves pain, understanding of pain, mobility, quality of life and Quantitative Electroencephalography (qEEG). This is a medical research study involving participants aged 65 years or older who have experienced pain for more than three months, with an intensity of at least 3 on a 0-to-10 scale. Participants will be randomly assigned to one of three groups, each following a different type of program: Group 1 (Control Group): will perform only adapted physical exercise. Group 2: will perform the same physical exercise and attend educational sessions about pain for 8 weeks. Group 3: will also perform the physical exercise and attend the educational sessions, but for a period of 32 weeks. The study will last for one full year. The exercise program will be supervised by physiotherapists, carried out over 32 weeks, three times per week, with each session lasting approximately 50 minutes. The educational sessions on pain will be brief-about 15 minutes each-and will take place immediately before the exercise sessions. During the first two months, there will be two educational talks per week. After the Christmas break, Group 3 will continue with one talk every two weeks until the end of the study. Three evaluations will be conducted: one before starting the program, another at two months (questionnaires and qEEG only), and a final one at nine months. The initial and final evaluation sessions will last approximately 75 minutes per participant, while the intermediate evaluation of the questionnaires will take about 45 minutes per person. The evaluators who conduct the assessments will not know which group each participant belongs to, to ensure that the results are as objective as possible.

Eligibility Criteria

Inclusion Criteria: * Adults over 65 years of age * History of pain lasting more than 3 months. * Pain intensity of at least 3 out of 10 on the numeric pain rating scale. * Ability to understand, speak, and write in Spanish. Exclusion Criteria: * Severe cognitive impairment (score \< 24 on the Mini-Mental State Exam). * Psychiatric disorders. * Uncontrolled systemic or inflammatory conditions. * Uncontrolled cardiac conditions. * Any other circumstances deemed by the investigators that could interfere with the study's purpose or conduct. Elimination Criteria: \- Attendance below 85% of total sessions.

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