Chronic Pain
Conditions
Keywords
Pain Education, Patient Education,, Exercise, Healthy Aging, Aged
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.
Detailed description
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: 1. Functional assessment: the following tests will be conducted: Short Physical Performance Battery (SPPB) and Timed Up & Go (TUG). 2. 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. 3. 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: 1. Numerical Rating Scale for Pain (NRS) 2. Tampa Scale for Kinesiophobia (TSK-11SV) 3. Pain Catastrophizing Scale 4. Spanish version of the Graded Chronic Pain Scale 5. SF-12 Health Survey Quantitative Electroencephalography (qEEG): (Spectral domain (brain frequencies, absolute and relative power by band), functional connectivity indices (coherence between regions), topographical or localization indices, complexity or temporal dynamics indices). All assessments will be administered by a trained and blinded physiotherapist under optimal hygiene and safety conditions, using certified equipment and instruments.
Interventions
OTHERMulticomponent training combined with Pain Science Education during 8 weeks
The intervention included multicomponent training, identical to that of the control group, combined with Pain Science Education lasting eight weeks, with two 15-minute sessions per week, totaling 16 sessions (240 minutes). The educational content covered topics such as pain, subjectivity and context, sensory homunculus and neurotag, the difference between acute and chronic pain, the distinction between damage and pain, the impact of chronic pain on older adults, the biopsychosocial approach to pain, exercise for long-term pain, attention and efferent copy, neuroplasticity, and relapses. To support the educational sessions, a PowerPoint with illustrative images and texts was used, along with two leaflets delivered at key points in the program. The first leaflet, titled Pain Science Education, was provided at the midpoint along with an envelope to store the materials. The second leaflet, Active Pain Coping, was given during the penultimate session. To reinforce and consolidate learni
The intervention consisted of multicomponent training lasting 32 weeks, with three 50-minute sessions per week. The training included strength, balance, endurance, and mobility exercises, with intensity adjusted according to each participant's individual progression and perceived exertion, using the Borg scale (\<7) as a reference.
OTHERMulticomponent training combined with Pain Science Education during 32 weeks
The intervention combined multicomponent training, identical to the control group, with a 32-week Pain Science Education program. Physical training, three 50-minute sessions per week, included strength, balance, endurance, and mobility exercises, with intensity individualized based on progression and perceived exertion (Borg \<7), supervised by physiotherapists. Education consisted of 24 sessions (15 minutes each): two weekly sessions during the first eight weeks and one session every two weeks thereafter. The first 16 sessions covered foundational topics, while the remaining eight reinforced concepts through talks, videos, role playing, problem-based learning, and guided debates. Practical tools included nutrition guidance, relaxation techniques, and a final guided self-reflection. Supporting materials included presentations, leaflets, a projector, and personalized cards for interactive activities.
Sponsors
University of Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
An experimental, prospective, and longitudinal study was proposed. A randomized clinical trial with three groups in a 1:1:1 ratio was conducted, in which adults over 65 years of age with chronic pain were recruited.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Scale (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale for Kinesiophobia (TSK-11) | 32 weeks | The TSK-11 is a shortened self-report tool used to assess fear of movement. It consists of 11 items scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), with a total score ranging from 11 to 44, where higher scores indicate greater levels of kinesiophobia. The TSK-11 was developed as a reduced version of the original 17-item scale after psychometric analysis identified six items with low statistical performance. Studies have shown that the TSK-11 has adequate internal consistency (Cronbach's alpha = 0.79), good test-retest reliability (ICC = 0.81; SEM = 2.54), as well as concurrent and predictive validity comparable to the original scale. It also demonstrated responsiveness to change (SRM = -1.11), making it suitable for evaluating therapeutic progress. This variable is considered continuous quantitative and is particularly relevant in research addressing psychosocial factors related to chronic pain and functional disability. |
| Pain Catastrophizing Scale (PCS) | 32 weeks | A 13-item self-report tool assessing negative thoughts about pain across rumination, magnification, and helplessness. Each item is scored 0-4 (total 0-52); higher scores indicate greater catastrophizing. It is reliable, valid, and important in chronic pain management. |
| Graded Chronic Pain Scale (GCPS) | 32 weeks | An 8-item scale measuring pain intensity and disability (total 0-70). Quick to administer, reliable, valid, and useful for classifying pain severity and functional impact. |
| SF-12 Health Survey | 32 weeks | A 12-item questionnaire assessing physical and mental health-related quality of life. Produces standardized scores and is widely used in research and clinical practice. |
| Sociodemographic Variables | 32 weeks | For each patient, the following data were recorded: full name, ID number, phone number, sex, marital status, medical history, presence of chronic conditions (such as hypertension, diabetes, high cholesterol, hypothyroidism, among others), use of additional medications, number of tablets taken daily, number of analgesics taken daily, living situation, educational level, and general clinical condition. Blood pressure and heart rate were also measured to ensure that the patient was in optimal condition to undergo the evaluations. |
| Short Physical Performance Battery (SPPB) | 32 weeks | A widely used tool in geriatric research to assess physical performance. It includes three tests measuring lower limb strength, gait speed, and balance. Total scores range from 0 to 12, with up to 4 points per component. Scores below 8 indicate low physical performance. The SPPB is quick, requires minimal equipment, and has high test-retest reliability, predictive validity, and clinical applicability. |
| Timed Up & Go (TUG) | 32 weeks | Assesses mobility and balance by timing how long a person takes to stand from a chair, walk 3 meters, turn, return, and sit down. The test is performed twice, taking the best time. Times exceeding age-specific thresholds indicate below-average performance: \>9.0s (60-69 years), \>10.2s (70-79 years), \>12.7s (80-99 years). |
| Handgrip strength (JAMAR dynamometer) | 32 weeks | Measures grip strength quantitatively in kilograms. Performed seated with elbow at 90º and neutral hand position. Each hand is tested alternately, taking the average. The JAMAR dynamometer shows excellent reproducibility and interrater reliability and is considered the gold standard for handgrip assessment. |
| Body Mass Index (BMI) | 32 weeks | Weight (kg) divided by height (m²). Classifies individuals into ranges and serves as a screening tool for body composition and risk of chronic disease, though it does not directly measure fat percentage. |
| Body fat percentage | 32 weeks | Indicates proportion of fat relative to total body weight. Normal ranges: men 12-20%, women 24-30%; obesity: men \>25%, women \>33%. Distribution (visceral vs. subcutaneous) is important for disease risk. |
| Visceral fat | 32 weeks | Fat surrounding internal organs, \ 10% of total body fat, linked to higher risk of cardiovascular, metabolic, and other diseases. |
| Appendicular skeletal muscle mass (ASM) | 32 weeks | Muscle mass in arms and legs. Measured via BIA, DXA, MRI, or anthropometry. BIA provides validated estimations of lean mass over time. |
| Skeletal Muscle Index (SMI) | 32 weeks | ASM adjusted for height (ASM/height²) to account for body size, as recommended by EWGSOP2. |
| Abdominal circumference | 32 weeks | Measured at the navel after full exhalation. Values \>102 cm in men and \>88 cm in women indicate increased health risk, providing information independent of BMI on central adiposity. |
| Change in Resting State Absolute Power of the Alpha Band | 32 weeks | Quantitative Electroencephalography (qEEG) will be used to assess cortical activity. The signal will be decomposed using Fast Fourier Transform (FFT). The specific outcome is the mean absolute power in the Alpha frequency band (8-12 Hz) across the regions of interest (ROIs). Changes in alpha power are associated with pain modulation and central sensitization mechanisms. Unit of Measure: Microvolts squared |
| Change in Functional Connectivity (Inter-regional Coherence) | 32 weeks | Functional connectivity between brain regions will be assessed using spectral coherence indices derived from the qEEG. Coherence indicates the degree of synchronization between two brain regions at specific frequencies. Values range from 0 (no correlation) to 1 (perfect correlation). This metric evaluates the integration of neural networks involved in pain processing. Unit of Measure: Coherence coefficient (0-1) |
| Force-velocity profile (ADR Encoder) | 32 weeks | Evaluates the relationship between muscle force and contraction speed. Measured during five rapid sit-to-stand repetitions using a linear encoder attached at the waist, recording power, speed, and distance. Reliable in older adults and useful for performance optimization. |
Countries
Spain
Contacts
Primary ContactJavier Torres Alonso, PDI
Outcome results
None listed