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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07565298
Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis
27 de abril de 2026 actualizado por: Pontificia Universidad Catolica de Chile
Multidimensional Assessment of the Activities of the "Camina 60+" Program for the Promotion of Healthy Aging - Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis: A Pilot Randomized Trial of Feasibility and Preliminary Effects.
This pilot trial aimed to estimate preliminary clinical effects and to assess the feasibility of adding group-based pain neuroscience education (PNE) to exercise in women aged ≥60 years with medically diagnosed knee osteoarthritis and current knee pain.
Participants were randomized to either 10 weeks of community-based exercise plus PNE or exercise alone.
All participants attended weekly group exercise sessions, and those in the intervention group also participated in five in-person group-based PNE sessions lasting 30 minutes each.
Physical fitness tests were administered, and participants completed questionnaires assessing disability, pain intensity, and pain neurophysiology knowledge.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Knee osteoarthritis (OA) is a highly prevalent and disabling condition in older adults, with the knee being the most commonly affected joint.
In Chile, OA represents a substantial clinical and public health burden, particularly among women aged 60 years and older, who experience high rates of pain, disability, and loss of functional independence.
Disability and pain are hallmark symptoms of knee OA and are strongly associated with reduced physical function and poorer quality of life in older women.
Current clinical guidelines recommend education, self-management, and exercise as first-line treatments.
Exercise therapy can improve pain and physical function in people with knee OA, but average effects are modest and individual responses vary.
Pain in knee OA is increasingly understood within a biopsychosocial framework, suggesting that maladaptive pain beliefs contribute to persistent symptoms.
Pain Neuroscience Education (PNE) may complement exercise by improving pain-related knowledge and psychological outcomes, although evidence-particularly for group-based delivery and disability outcomes in older women-remains limited.
This study was implemented in the context of a training program called "Camina 60+KineUC", a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy from Pontificia Universidad Católica de Chile.
The program provides weekly group sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older and is designed to promote healthy aging.
The study was designed to assess feasibility and estimate preliminary between-group effect sizes rather than to make definitive efficacy conclusions.
Tipo de estudio
Intervencionista
Inscripción (Actual)
19
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Santiago, Chile
- Pontificia Universidad Católica de Chile
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Medical diagnosis of knee osteoarthritis with current knee pain.
Exclusion Criteria:
- Inability to understand study procedures during baseline assessment. Mini-Mental State Examination (MMSE) cutoff used to define adequate comprehension for study participation was ≥24/30).
- Severe neurological disease.
- Anticipated inability to attend all educational sessions or attendance less than 80% at the end of the program.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Exercise plus Pain Neuroscience Education
In addition to the 10-week Camina 60+KineUC exercise program, this group received five in-person group-based Pain Neuroscience Education (PNE) sessions lasting 30 minutes each.
Sessions were delivered across the intervention period using standardized digital presentations, for a total dose aligned with evidence suggesting psychosocial benefits when PNE is combined with exercise.
The intervention was delivered by four fourth-year physical therapy students trained in PNE, based on recognized educational resources.
Intervention fidelity was ensured through prior training, use of standardized materials, and adherence to a prespecified session checklist.
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The intervention group received five group-based PNE sessions of 30 min each ((total dose = 150 min) delivered in person across the 10-week intervention period using digital presentations.
The selected dose was informed by dose-response syntheses suggesting that 150-200 min of PNE may be associated with clinically relevant changes in psychosocial outcomes when combined with exercise.
Sessions were delivered by four fourth-year physical therapy students trained in PNE and were based on The Knee Osteoarthritis Handbook (Noigroup©) and Dolor Crónico, una guía de ayuda para pacientes (Equipo DolorUC book).
To support intervention fidelity, the student facilitators completed 5 days of 2hrs of training in PNE and communications skills before delivering the intervention, used a standardized slide deck and session script, and followed a prespecified checklist for each session.
The "Camina 60+KineUC" is a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy of the Pontificia Universidad Católica de Chile.
The program provides weekly group in-person sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older, guided by monitors (physiotherapists and trained physiotherapy students), considering progression in movement complexity, or balance challenge according to tolerance, throughout the 10 weeks of the program.
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Comparador activo: Exercise-only group
Camina 60+KineUC exercise program for 10 weeks, which consists of group exercise sessions delivered weekly, in person, and includes strength, aerobic, balance, and flexibility exercises.
Each exercise session lasted 60min and was delivered by the monitors of Camina60+.
Sessions included warm-up, strengthening, aerobic training, balance, and flexibility.
Progression across the 10-week intervention period was standardized by movement complexity, or balance challenge according to tolerance.
After study completion, they were offered the same group-based PNE program provided to the intervention group.
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The "Camina 60+KineUC" is a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy of the Pontificia Universidad Católica de Chile.
The program provides weekly group in-person sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older, guided by monitors (physiotherapists and trained physiotherapy students), considering progression in movement complexity, or balance challenge according to tolerance, throughout the 10 weeks of the program.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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KOOS - Activities of Daily Living (KOOS-ADL)
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Self-reported disability during activities of daily living, measured using the Activities of Daily Living subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS).
The KOOS is a knee-specific, self-administered questionnaire.
The ADL subscale is scored from 0 to 100, with higher scores indicating better knee-related function.
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Baseline and immediately after the 10-week intervention period.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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KOOS - Pain Subscale
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Knee pain measured using the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Scores range from 0 to 100, with higher scores indicating less pain and better knee status.
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Baseline and immediately after the 10-week intervention period.
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KOOS - Symptoms Subscale
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Knee-related symptoms measured using the Symptoms subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Scores range from 0 to 100, with higher scores indicating fewer symptoms.
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Baseline and immediately after the 10-week intervention period.
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KOOS - Sport and Recreation Function Subscale
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Self-reported difficulty with sport and recreational activities measured using the Sport and Recreation Function subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Scores range from 0 to 100, with higher scores indicating better function.
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Baseline and immediately after the 10-week intervention period.
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KOOS - Knee-related Quality of Life Subscale
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Knee-related quality of life measured using the Quality of Life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Scores range from 0 to 100, with higher scores indicating better knee-related quality of life.
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Baseline and immediately after the 10-week intervention period.
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Pain intensity
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Pain intensity was assessed with a 10-cm visual analog scale, with higher scores indicating greater pain intensity.
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Baseline and immediately after the 10-week intervention period.
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Lower-body functional performance
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Lower-body functional performance was assessed with the 30-s Sit-to-Stand Test, scored as the number of repetitions completed in 30 seconds.
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Baseline and immediately after the 10-week intervention period.
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Pain neurophysiology knowledge
Periodo de tiempo: Baseline and immediately after the 10-week intervention period.
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Pain neurophysiology knowledge was assessed with the Spanish version of the Revised Neurophysiology of Pain Questionnaire (R-NPQ), with higher scores indicating greater knowledge.
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Baseline and immediately after the 10-week intervention period.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility - Screening and Recruitment
Periodo de tiempo: From enrollment to the end of the 10-week intervention.
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Number of participants assessed for eligibility, excluded, and randomized.
Unit of Measure: Number of participants
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From enrollment to the end of the 10-week intervention.
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Feasibility - Retention
Periodo de tiempo: From enrollment to the end of the 10-week intervention.
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Retention defined as the proportion of randomized participants who completed the post-intervention assessment.
Unit of Measure: Percentage of participants (%)
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From enrollment to the end of the 10-week intervention.
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Feasibility - Exercise Adherence
Periodo de tiempo: From enrollment to the end of the 10-week intervention.
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Exercise adherence defined as attendance at ≥80% of scheduled exercise sessions during the intervention period.
Unit of Measure: Percentage of participants meeting adherence criterion (%)
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From enrollment to the end of the 10-week intervention.
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Feasibility - Attendance at Pain Neuroscience Education Sessions
Periodo de tiempo: From enrollment to the end of the 10-week intervention.
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Attendance defined as the number of group-based Pain Neuroscience Education (PNE) sessions attended (0-5) among participants allocated to the intervention group.
Unit of Measure: Number of sessions attended
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From enrollment to the end of the 10-week intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Gustavo Torres, Pontificia Universidad Católica de Chile
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
- Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
- Catley MJ, O'Connell NE, Moseley GL. How good is the neurophysiology of pain questionnaire? A Rasch analysis of psychometric properties. J Pain. 2013 Aug;14(8):818-27. doi: 10.1016/j.jpain.2013.02.008. Epub 2013 May 4.
- Salazar-Mendez J, Nunez-Cortes R, Suso-Marti L, Ribeiro IL, Garrido-Castillo M, Gacitua J, Mendez-Rebolledo G, Cruz-Montecinos C, Lopez-Bueno R, Calatayud J. Dosage matters: Uncovering the optimal duration of pain neuroscience education to improve psychosocial variables in chronic musculoskeletal pain. A systematic review and meta-analysis with moderator analysis. Neurosci Biobehav Rev. 2023 Oct;153:105328. doi: 10.1016/j.neubiorev.2023.105328. Epub 2023 Jul 27.
- 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.
- Molina-Donoso M, Gonzalez-Hernandez J, Delgado C, Cancino V, Bello-Lepe S, Alonso-Sanchez MF, Forno G, Henriquez F, Lillo P, Musa G, Alegria P, Delano PH, Retuerto N, Amieva H, Slachevsky A. [Development of Normative Data for the Mini Mental State Examination (MMSE) in the Elderly Population of Chile: A Multi-City Study]. Rev Med Chil. 2023 Nov;151(11):1464-1470. doi: 10.4067/s0034-98872023001101464. Spanish.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2024
Finalización primaria (Actual)
30 de noviembre de 2024
Finalización del estudio (Actual)
30 de noviembre de 2024
Fechas de registro del estudio
Enviado por primera vez
16 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Osteoartritis
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Dolor
- Artrosis, Rodilla
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- 240131002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The small sample size of the study may limit the ability to fully ensure participant confidentiality if individual-level data were to be shared.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .