NCT07287501

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
OTHER	Multicomponent 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
OTHER	Multicomponent training	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.
OTHER	Multicomponent 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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-12-17
• Last updated: 2026-01-07

Locations

1 site across 1 country: Spain