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

NCT07287501 | Recruiting

• 1 other identifier: USalamancanº1424
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

"Pain Education"; "Patient Education",; "Exercise"; "Healthy Aging"; "Aged"

Outcome Measures

Primary Outcomes (1)

• 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.

  32 weeks

Secondary Outcomes (17)

• Tampa Scale for Kinesiophobia (TSK-11)

  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

Study Arms (3)

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.

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.

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.

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

Interventions

Multicomponent training combined with Pain Science Education during 8 weeks OTHER

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

Also known as: Patient Education, neuroscience pain education, Pain science education, pain education

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

Multicomponent training combined with Pain Science Education during 32 weeks OTHER

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.

Also known as: pain education, neuroscience pain education, Patient Education, Pain science education

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

Multicomponent training OTHER

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.

Also known as: exercise, strenght exercise

Multicomponent training control group (GC).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Faculty of Nursing and Physiotherapy USAL. Campus Miguel de Unamuno, C. Donantes de Sangre, s/n, 37007 Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Related Publications (13)

• 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.

  PMID: 37464184 BACKGROUND

• Lam 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.

  PMID: 37853269 BACKGROUND

• Zahari 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.

  PMID: 31356191 BACKGROUND

• Watson 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.

  PMID: 32585363 BACKGROUND

• Nunez-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.

  PMID: 38047772 BACKGROUND

• Nijs 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.

  PMID: 21632273 BACKGROUND

• Sluka 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.

  PMID: 30113953 BACKGROUND

• Carville 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.

  PMID: 33883123 BACKGROUND

• Castellini 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.

  PMID: 33092579 BACKGROUND

• Cai 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.

  PMID: 35061871 BACKGROUND

• Lin 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.

  PMID: 32808241 BACKGROUND

• Domenichiello 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.

  PMID: 31004724 BACKGROUND

• Cimas 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.

  PMID: 29235193 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Patient Education as Topic; Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Javier Torres Alonso, PDI

CONTACT

+34 684111479; javiertorres@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate in physiotherapy

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data and supporting information (Study Protocol, Statistical Analysis Plan, Informed Consent Form, and Analytical Code) will be available starting 6 months after the publication of the main manuscript in a scientific journal, and will remain available indefinitely through the Principal Investigator or a permanent data repository.
• Access Criteria: Access to the anonymized IPD and supporting documents (Protocol, SAP, ICF, Analytical Code) is granted to qualified scientific investigators whose proposal is deemed methodologically sound and aligns with the study's ethical goals. Requests must be submitted formally to the Principal Investigator. Access requires the applicant to sign a Data Use Agreement (DUA), ensuring compliance with the confidentiality measures set forth in the original informed consent, and adherence to relevant data protection regulations (e.g., GDPR). The DUA will strictly prohibit any attempt at participant re-identification and must include a commitment to using the data solely for the approved research purpose.

Locations

ES (1)