Chronic PainPSE-EX-OANCT07287501
Efficacy of Pain Science Education Combined With Exercise in Older Adults With Chronic Pain
A study testing Multicomponent training combined with Pain Science Education during 8 weeks, Multicomponent training and Multicomponent training combined with Pain Science Education during 32 weeks in people with Chronic Pain, run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Multicomponent training combined with Pain Science Education during 8 weeks, Multicomponent training and Multicomponent training combined with Pain Science Education during 32 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Nursing and Physiotherapy USAL. Campus Miguel de Unamuno, C. Donantes de Sangre, s/n, 37007 Salamanca
Salamanca, Salamanca, 37007
Javier Torres Alonso, PDI, +34 684111479, javiertorres@usal.es
About this study
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.
Read more
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.
Read the 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:
- 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:
- Numerical Rating Scale for Pain (NRS)
- Tampa Scale for Kinesiophobia (TSK-11SV)
- Pain Catastrophizing Scale
- Spanish version of the Graded Chronic Pain Scale
- 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
- Being tested
- Multicomponent training combined with Pain Science Education during 8 weeks, Multicomponent training, Multicomponent training combined with Pain Science Education during 32 weeks
- Keywords
- "Pain Education", "Patient Education",, "Exercise", "Healthy Aging", "Aged"
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent training combined with Pain Science Education during 8 weeksOther
Also called Patient Education, neuroscience pain education, Pain science education, pain education
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
Multicomponent trainingOther
Also called exercise, strenght exercise
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.
Multicomponent training combined with Pain Science Education during 32 weeksOther
Also called pain education, neuroscience pain education, Patient Education, Pain science education
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent training control group (GC). | Active comparator | 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. Receives: Other: Multicomponent training |
| Multicomponent training group and ECD for 8 weeks (GI1). | Experimental | 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. Receives: Other: Multicomponent training combined with Pain Science Education during 8 weeks |
| Multicomponent training group and ECD for 32 weeks (GI2). | Experimental | 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. Receives: Other: Multicomponent training combined with Pain Science Education during 32 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale (NRS)
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.
Measured: 32 weeks
Secondary outcomes (17)
Tampa Scale for Kinesiophobia (TSK-11)
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.
Measured: 32 weeks
Pain Catastrophizing Scale (PCS)
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.
Measured: 32 weeks
Graded Chronic Pain Scale (GCPS)
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.
Measured: 32 weeks
SF-12 Health Survey
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.
Measured: 32 weeks
Sociodemographic Variables
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.
Measured: 32 weeks
Short Physical Performance Battery (SPPB)
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.
Measured: 32 weeks
Timed Up & Go (TUG)
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).
Measured: 32 weeks
Handgrip strength (JAMAR dynamometer)
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.
Measured: 32 weeks
Force-velocity profile (ADR Encoder)
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.
Measured: 32 weeks
Body Mass Index (BMI)
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.
Measured: 32 weeks
Body fat percentage
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.
Measured: 32 weeks
Visceral fat
Fat surrounding internal organs, ~10% of total body fat, linked to higher risk of cardiovascular, metabolic, and other diseases.
Measured: 32 weeks
Appendicular skeletal muscle mass (ASM)
Muscle mass in arms and legs. Measured via BIA, DXA, MRI, or anthropometry. BIA provides validated estimations of lean mass over time.
Measured: 32 weeks
Skeletal Muscle Index (SMI)
ASM adjusted for height (ASM/height²) to account for body size, as recommended by EWGSOP2.
Measured: 32 weeks
Abdominal circumference
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.
Measured: 32 weeks
Change in Resting State Absolute Power of the Alpha Band
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
Measured: 32 weeks
Change in Functional Connectivity (Inter-regional Coherence)
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)
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Oct 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Torres Alonso, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287501
- Sponsor's protocol ID
- USalamancanº1424
- Acronym
- PSE-EX-OA
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized Individual Participant Data (IPD) set supporting the main publication will be made available to other researchers. This will include data from the Quantitative Electroencephalography (qEEG) variables, behavioral measures, and relevant demographic variables, always ensuring the non-identification of participants, as established in the approved informed consent. Data will be accessible starting 6 months after the primary article's publication, with no end date. Access will be granted upon formal request to the Principal Investigator, submission of a methodologically sound research proposal, and the signing of a Data Use Agreement (DUA) to ensure the protection of participant privacy.
Publications
Soares Fonseca L, Pereira Silva J, Bastos Souza M, Gabrich Moraes Campos M, de Oliveira Mascarenhas R, de Jesus Silva H, Souza Maximo Pereira L, Xavier Oliveira M, Cunha Oliveira V. Effectiveness of pharmacological and non-pharmacological therapy on pain intensity and disability in older people with chronic nonspecific low back pain: a systematic review with meta-analysis. Eur Spine J. 2023 Sep;32(9):3245-3271. doi: 10.1007/s00586-023-07857-4. Epub 2023 Jul 18.
PubMed 37464184Lam N, Green J, Hallas S, Forster A, Crocker TF, Andre D, Ellwood A, Clegg A, Brown L. Mapping review of pain management programmes and psychological therapies for community-dwelling older people living with pain. Eur Geriatr Med. 2024 Feb;15(1):33-45. doi: 10.1007/s41999-023-00871-1. Epub 2023 Oct 18.
PubMed 37853269Zahari Z, Ishak A, Justine M. The effectiveness of patient education in improving pain, disability and quality of life among older people with low back pain: A systematic review. J Back Musculoskelet Rehabil. 2020;33(2):245-254. doi: 10.3233/BMR-181305.
PubMed 31356191Watson JA, Ryan CG, Atkinson G, Williamson P, Ellington D, Whittle R, Dixon J, Martin DJ. Inter-Individual Differences in the Responses to Pain Neuroscience Education in Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Pain. 2021 Jan;22(1):9-20. doi: 10.1016/j.jpain.2020.03.006. Epub 2020 Jun 22.
PubMed 32585363Nunez-Cortes R, Salazar-Mendez J, Calatayud J, Malfliet A, Lluch E, Mendez-Rebolledo G, Guzman-Munoz E, Lopez-Bueno R, Suso-Marti L. The optimal dose of pain neuroscience education added to an exercise programme for patients with chronic spinal pain: a systematic review and dose-response meta-analysis. Pain. 2024 Jun 1;165(6):1196-1206. doi: 10.1097/j.pain.0000000000003126. Epub 2023 Nov 30.
PubMed 38047772Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.
PubMed 21632273Sluka KA, Frey-Law L, Hoeger Bement M. Exercise-induced pain and analgesia? Underlying mechanisms and clinical translation. Pain. 2018 Sep;159 Suppl 1(Suppl 1):S91-S97. doi: 10.1097/j.pain.0000000000001235.
PubMed 30113953Carville S, Constanti M, Kosky N, Stannard C, Wilkinson C; Guideline Committee. Chronic pain (primary and secondary) in over 16s: summary of NICE guidance. BMJ. 2021 Apr 21;373:n895. doi: 10.1136/bmj.n895. No abstract available.
PubMed 33883123Castellini G, Iannicelli V, Briguglio M, Corbetta D, Sconfienza LM, Banfi G, Gianola S. Are clinical practice guidelines for low back pain interventions of high quality and updated? A systematic review using the AGREE II instrument. BMC Health Serv Res. 2020 Oct 22;20(1):970. doi: 10.1186/s12913-020-05827-w.
PubMed 33092579Cai Y, Leveille SG, Shi L, Chen P, You T. Chronic pain and circumstances of falls in community-living older adults: an exploratory study. Age Ageing. 2022 Jan 6;51(1):afab261. doi: 10.1093/ageing/afab261.
PubMed 35061871Lin T, Zhao Y, Xia X, Ge N, Yue J. Association between frailty and chronic pain among older adults: a systematic review and meta-analysis. Eur Geriatr Med. 2020 Dec;11(6):945-959. doi: 10.1007/s41999-020-00382-3. Epub 2020 Aug 17.
PubMed 32808241Domenichiello AF, Ramsden CE. The silent epidemic of chronic pain in older adults. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jul 13;93:284-290. doi: 10.1016/j.pnpbp.2019.04.006. Epub 2019 Apr 17.
PubMed 31004724Cimas M, Ayala A, Sanz B, Agullo-Tomas MS, Escobar A, Forjaz MJ. Chronic musculoskeletal pain in European older adults: Cross-national and gender differences. Eur J Pain. 2018 Feb;22(2):333-345. doi: 10.1002/ejp.1123. Epub 2017 Dec 12.
PubMed 29235193Torres-Alonso J, Polo-Ferrero L, Hernandez-Rubia S, Sanchez-Sanchez MC, Puente-Gonzalez AS, Saez-Gutierrez S, Mendez-Sanchez R, Barbero-Iglesias FJ. Efficacy of Pain Neuroscience Education Combined with Exercise in Older Adults with Chronic Pain: Study Protocol for a Randomized Controlled Trial. J Clin Med. 2026 May 11;15(10):3696. doi: 10.3390/jcm15103696.
PubMed 42194657
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pain Science Education Combined With Exercise in Older Adults With Chronic Pain
- ClinicalTrials.gov ID
- NCT07287501
- Acronym / sponsor ID
- PSE-EX-OA / USalamancanº1424
- Conditions
- Chronic Pain
- Keywords
- "Pain Education", "Patient Education",, "Exercise", "Healthy Aging", "Aged"
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Numerical Rating Scale for Pain (NRS)
- Tampa Scale for Kinesiophobia (TSK-11SV)
- Pain Catastrophizing Scale
- Spanish version of the Graded Chronic Pain Scale
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent training control group (GC). | Active comparator | Other: Multicomponent trainingThe 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. |
| Multicomponent training group and ECD for 8 weeks (GI1). | Experimental | Other: Multicomponent training combined with Pain Science Education during 8 weeksGI1 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. |
| Multicomponent training group and ECD for 32 weeks (GI2). | Experimental | Other: Multicomponent training combined with Pain Science Education during 32 weeksGI2 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent training combined with Pain Science Education during 8 weeksAlso: Patient Education, neuroscience pain education, Pain science education, pain educationThe 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 group and ECD for 8 weeks (GI1). |
| Multicomponent trainingAlso: exercise, strenght exerciseThe 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 control group (GC). |
| Multicomponent training combined with Pain Science Education during 32 weeksAlso: pain education, neuroscience pain education, Patient Education, Pain science educationThe 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. | Other | Multicomponent training group and ECD for 32 weeks (GI2). |
Primary outcome
Numeric Pain Scale (NRS)
Time frame: 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.
17 secondary outcomes
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: 32 weeks
Pain Catastrophizing Scale (PCS)
Time frame: 32 weeks
Graded Chronic Pain Scale (GCPS)
Time frame: 32 weeks
SF-12 Health Survey
Time frame: 32 weeks
Sociodemographic Variables
Time frame: 32 weeks
Short Physical Performance Battery (SPPB)
Time frame: 32 weeks
Timed Up & Go (TUG)
Time frame: 32 weeks
Handgrip strength (JAMAR dynamometer)
Time frame: 32 weeks
Force-velocity profile (ADR Encoder)
Time frame: 32 weeks
Body Mass Index (BMI)
Time frame: 32 weeks
Body fat percentage
Time frame: 32 weeks
Visceral fat
Time frame: 32 weeks
Appendicular skeletal muscle mass (ASM)
Time frame: 32 weeks
Skeletal Muscle Index (SMI)
Time frame: 32 weeks
Abdominal circumference
Time frame: 32 weeks
Change in Resting State Absolute Power of the Alpha Band
Time frame: 32 weeks
Change in Functional Connectivity (Inter-regional Coherence)
Time frame: 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 37464184Soares Fonseca L, Pereira Silva J, Bastos Souza M, Gabrich Moraes Campos M, de Oliveira Mascarenhas R, de Jesus Silva H, Souza Maximo Pereira L, Xavier Oliveira M, Cunha Oliveira V. Effectiveness of pharmacological and non-pharmacological therapy on pain intensity and disability in older people with chronic nonspecific low back pain: a systematic review with meta-analysis. Eur Spine J. 2023 Sep;32(9):3245-3271. doi: 10.1007/s00586-023-07857-4. Epub 2023 Jul 18.
- Background: PubMed 37853269Lam N, Green J, Hallas S, Forster A, Crocker TF, Andre D, Ellwood A, Clegg A, Brown L. Mapping review of pain management programmes and psychological therapies for community-dwelling older people living with pain. Eur Geriatr Med. 2024 Feb;15(1):33-45. doi: 10.1007/s41999-023-00871-1. Epub 2023 Oct 18.
- Background: PubMed 31356191Zahari Z, Ishak A, Justine M. The effectiveness of patient education in improving pain, disability and quality of life among older people with low back pain: A systematic review. J Back Musculoskelet Rehabil. 2020;33(2):245-254. doi: 10.3233/BMR-181305.
- Background: PubMed 32585363Watson JA, Ryan CG, Atkinson G, Williamson P, Ellington D, Whittle R, Dixon J, Martin DJ. Inter-Individual Differences in the Responses to Pain Neuroscience Education in Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Pain. 2021 Jan;22(1):9-20. doi: 10.1016/j.jpain.2020.03.006. Epub 2020 Jun 22.
- Background: PubMed 38047772Nunez-Cortes R, Salazar-Mendez J, Calatayud J, Malfliet A, Lluch E, Mendez-Rebolledo G, Guzman-Munoz E, Lopez-Bueno R, Suso-Marti L. The optimal dose of pain neuroscience education added to an exercise programme for patients with chronic spinal pain: a systematic review and dose-response meta-analysis. Pain. 2024 Jun 1;165(6):1196-1206. doi: 10.1097/j.pain.0000000000003126. Epub 2023 Nov 30.
- Background: PubMed 21632273Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.
- Background: PubMed 30113953Sluka KA, Frey-Law L, Hoeger Bement M. Exercise-induced pain and analgesia? Underlying mechanisms and clinical translation. Pain. 2018 Sep;159 Suppl 1(Suppl 1):S91-S97. doi: 10.1097/j.pain.0000000000001235.
- Background: PubMed 33883123Carville S, Constanti M, Kosky N, Stannard C, Wilkinson C; Guideline Committee. Chronic pain (primary and secondary) in over 16s: summary of NICE guidance. BMJ. 2021 Apr 21;373:n895. doi: 10.1136/bmj.n895. No abstract available.
- Background: PubMed 33092579Castellini G, Iannicelli V, Briguglio M, Corbetta D, Sconfienza LM, Banfi G, Gianola S. Are clinical practice guidelines for low back pain interventions of high quality and updated? A systematic review using the AGREE II instrument. BMC Health Serv Res. 2020 Oct 22;20(1):970. doi: 10.1186/s12913-020-05827-w.
- Background: PubMed 35061871Cai Y, Leveille SG, Shi L, Chen P, You T. Chronic pain and circumstances of falls in community-living older adults: an exploratory study. Age Ageing. 2022 Jan 6;51(1):afab261. doi: 10.1093/ageing/afab261.
- Background: PubMed 32808241Lin T, Zhao Y, Xia X, Ge N, Yue J. Association between frailty and chronic pain among older adults: a systematic review and meta-analysis. Eur Geriatr Med. 2020 Dec;11(6):945-959. doi: 10.1007/s41999-020-00382-3. Epub 2020 Aug 17.
- Background: PubMed 31004724Domenichiello AF, Ramsden CE. The silent epidemic of chronic pain in older adults. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jul 13;93:284-290. doi: 10.1016/j.pnpbp.2019.04.006. Epub 2019 Apr 17.
- Individual participant dataSharing planned: Yes. The anonymized Individual Participant Data (IPD) set supporting the main publication will be made available to other researchers. This will include data from the Quantitative Electroencephalography (qEEG) variables, behavioral measures, and relevant demographic variables, always ensuring the non-identification of participants, as established in the approved informed consent. Data will be accessible starting 6 months after the primary article's publication, with no end date. Access will be granted upon formal request to the Principal Investigator, submission of a methodologically sound research proposal, and the signing of a Data Use Agreement (DUA) to ensure the protection of participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent training combined with Pain Science Education during 8 weeks, Multicomponent training and Multicomponent training combined with Pain Science Education during 32 weeks in people with Chronic Pain, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Torres Alonso, PDI (+34 684111479, javiertorres@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Scale (NRS) (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07287501, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.