Efficacy of Pain Science Education Combined With Exercise in Older Adults With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Numeric Pain Scale (NRS)
研究概览
简要总结
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.
详细描述
During the course of the study, the following information will be collected, and the following types of tests and assessments will be carried out:
Personal information and medical history.
Physical condition assessments:
- Functional assessment: the following tests will be conducted: Short Physical Performance Battery (SPPB) and Timed Up & Go (TUG).
- Muscle strength assessment: the following tests will be performed: handgrip strength test using a JAMAR dynamometer, five-times sit-to-stand test, and force-velocity profiling using an ADR Encoder.
- Body composition assessment: will be obtained by bioelectrical impedance analysis (BIA), including measurements of body weight, body mass index (BMI), body fat, visceral fat, appendicular muscle mass, and appendicular mass index.
Questionnaires:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, it was not possible to implement complete blinding of the study participants. However, the study employed a single-blind design, in which the professionals responsible for the assessments were unaware of the participants' allocation to the intervention or control groups. Likewise, the statistical analyses were performed using coded data to ensure the objectivity of the independent researcher responsible for the statistical evaluation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Multicomponent training control group (GC).
The CG implemented a multicomponent training program lasting 32 weeks. Sessions were held three times a week, each lasting 50 minutes. The program included strength, balance, endurance, and mobility training, with individualized intensity adjustments based on progression and perceived exertion, using the Borg scale (<7) as a reference.
干预措施: Multicomponent training (Other)
Multicomponent training group and ECD for 8 weeks (GI1).
GI1 completed the same multicomponent training as the CG, but supplemented it with an 8-week ECD program. This training consisted of two 15-minute sessions per week (16 classes total), which addressed topics such as the difference between acute and chronic pain, neuroplasticity, the biopsychosocial approach to pain, and the impact on older adults. Supporting information was provided through presentations with images, brochures distributed at key moments, and review questionnaires, concluding with a resource and social support sheet.
干预措施: Multicomponent training combined with Pain Science Education during 8 weeks (Other)
Multicomponent training group and ECD for 32 weeks (GI2).
GI2 combined the same multicomponent training as CG with an extended ECD program over 32 weeks. The first 8 weeks included two 15-minute sessions per week, followed by a biweekly session, completing 24 classes. The initial content was the same as GI1, but subsequent sessions reinforced concepts through lectures, videos, role-playing, clinical case studies, and debates. Dietary guidelines, relaxation techniques, and a final guided self-reflection session were also included. The support materials included the same content as GI1, along with cards and resources specific to the dynamics.
干预措施: Multicomponent training combined with Pain Science Education during 32 weeks (Other)
结局指标
主要结局
Numeric Pain Scale (NRS)
时间窗: 32 weeks
The Numeric Rating Scale (NRS) is a one-dimensional tool used to measure the intensity of pain perceived by an individual at a given time. It is based on self-assessment by the patient, who assigns a numerical value from 0 to 10 to their pain, where 0 indicates total absence of pain and 10 represents the worst pain imaginable. Pain between 1 and 3 is considered mild pain, between 4 and 7 moderate, and 8 to 10 severe. This variable is classified as a continuous quantitative variable. The NRS is administered in written form, is easy to understand, and does not require complex instruments, allowing its use in various clinical settings. It has been shown to be feasible and to show high correlations with other pain assessment tools. Furthermore, it is suitable for older adults with chronic pain participating in interdisciplinary pain rehabilitation.
次要结局
- Tampa Scale for Kinesiophobia (TSK-11)(32 weeks)
- Body fat percentage(32 weeks)
- Visceral fat(32 weeks)
- Abdominal circumference(32 weeks)
- Pain Catastrophizing Scale (PCS)(32 weeks)
- Graded Chronic Pain Scale (GCPS)(32 weeks)
- SF-12 Health Survey(32 weeks)
- Sociodemographic Variables(32 weeks)
- Short Physical Performance Battery (SPPB)(32 weeks)
- Force-velocity profile (ADR Encoder)(32 weeks)
- Timed Up & Go (TUG)(32 weeks)
- Handgrip strength (JAMAR dynamometer)(32 weeks)
- Appendicular skeletal muscle mass (ASM)(32 weeks)
- Body Mass Index (BMI)(32 weeks)
- Skeletal Muscle Index (SMI)(32 weeks)
- Change in Resting State Absolute Power of the Alpha Band(32 weeks)
- Change in Functional Connectivity (Inter-regional Coherence)(32 weeks)
研究者
Javier Torres Alonso
Graduate in physiotherapy
University of Salamanca