- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07565298
Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis
April 27, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Santiago, Chile
- Pontificia Universidad Catolica de Chile
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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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Active Comparator: 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.
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KOOS - Activities of Daily Living (KOOS-ADL)
Time Frame: Baseline and immediately after the 10-week intervention period.
|
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.
|
Baseline and immediately after the 10-week intervention period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KOOS - Pain Subscale
Time Frame: Baseline and immediately after the 10-week intervention period.
|
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.
|
Baseline and immediately after the 10-week intervention period.
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|
KOOS - Symptoms Subscale
Time Frame: 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.
|
|
KOOS - Sport and Recreation Function Subscale
Time Frame: 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.
|
Baseline and immediately after the 10-week intervention period.
|
|
KOOS - Knee-related Quality of Life Subscale
Time Frame: 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.
|
Baseline and immediately after the 10-week intervention period.
|
|
Pain intensity
Time Frame: 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
Time Frame: 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
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Screening and Recruitment
Time Frame: From enrollment to the end of the 10-week intervention.
|
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
Time Frame: From enrollment to the end of the 10-week intervention.
|
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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gustavo Torres, Pontificia Universidad Catolica de Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2024
Primary Completion (Actual)
November 30, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain
- Osteoarthritis, Knee
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 240131002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The small sample size of the study may limit the ability to fully ensure participant confidentiality if individual-level data were to be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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