Efficacy of Pain Science Education Combined With Exercise in Older Adults With Chronic Pain (PSE-EX-OA)

University of Salamanca

Status: Enrolling

Conditions: Chronic Pain

Treatments: Other: Multicomponent training; Other: Multicomponent training combined with Pain Science Education during 32 weeks; Other: Multicomponent training combined with Pain Science Education during 8 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT07287501

USalamancanº1424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Multicomponent training control group (GC).

Active Comparator group

Description:

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.

Treatment:

Other: Multicomponent training

Multicomponent training group and ECD for 8 weeks (GI1).

Experimental group

Description:

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.

Treatment:

Other: Multicomponent training combined with Pain Science Education during 8 weeks

Multicomponent training group and ECD for 32 weeks (GI2).

Experimental group

Description:

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.

Treatment:

Other: Multicomponent training combined with Pain Science Education during 32 weeks