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Knee OsteoarthritisNCT07565298

Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis

A study testing Pain neuroscience education (PNE) and Exercise program in people with Knee Osteoarthritis and Older Women, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Knee Osteoarthritis, Older Women, Pain
What is being tested?
Pain neuroscience education (PNE) and Exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChile
Study dates
1 Aug 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

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 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Medical diagnosis of knee osteoarthritis with current knee pain.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Pontificia Universidad Católica de Chile

    Santiago

Other trials in Chile

About this study

Official title: 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.

Read the 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.

Being tested
Pain neuroscience education (PNE), Exercise program
Keywords
Pain Neuroscience Education, Knee Osteoarthritis, Older Women, Disability, Exercise, Pilot randomized controlled trial
Medical subject headings
Osteoarthritis, Knee, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain neuroscience education (PNE)Other

    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.

  • Exercise programOther

    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.

Study groups in NCT07565298
Study groupRoleWhat they receive
Exercise plus Pain Neuroscience EducationExperimentalIn 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.
Receives: Other: Pain neuroscience education (PNE); Other: Exercise program
Exercise-only groupActive comparatorCamina 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.
Receives: Other: Exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KOOS - Activities of Daily Living (KOOS-ADL)

    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.

    Measured: Baseline and immediately after the 10-week intervention period.

Secondary outcomes (7)
  1. KOOS - Pain Subscale

    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.

    Measured: Baseline and immediately after the 10-week intervention period.

  2. KOOS - Symptoms Subscale

    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.

    Measured: Baseline and immediately after the 10-week intervention period.

  3. KOOS - Sport and Recreation Function Subscale

    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.

    Measured: Baseline and immediately after the 10-week intervention period.

  4. KOOS - Knee-related Quality of Life Subscale

    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.

    Measured: Baseline and immediately after the 10-week intervention period.

  5. Pain intensity

    Pain intensity was assessed with a 10-cm visual analog scale, with higher scores indicating greater pain intensity.

    Measured: Baseline and immediately after the 10-week intervention period.

  6. Lower-body functional performance

    Lower-body functional performance was assessed with the 30-s Sit-to-Stand Test, scored as the number of repetitions completed in 30 seconds.

    Measured: Baseline and immediately after the 10-week intervention period.

  7. Pain neurophysiology knowledge

    Pain neurophysiology knowledge was assessed with the Spanish version of the Revised Neurophysiology of Pain Questionnaire (R-NPQ), with higher scores indicating greater knowledge.

    Measured: Baseline and immediately after the 10-week intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start1 Aug 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

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
Two-arm, parallel-group randomized controlled trial conducted between August and November 2024 at the San Joaquín Campus of Pontificia Universidad Católica de Chile, Santiago, Chile. Potentially eligible participants were identified during the initial Camina 60+KineUC sessions using the program questionnaire and functional assessment battery that included the Senior Fitness Test and the Four-Stage Balance Test. Participants who met the eligibility criteria and provided written informed consent were randomized in a 1:1 ratio to exercise plus pain neuroscience education (PNE) or exercise only. The allocation sequence was computer generated with OxMaR software, and age was used as the balancing factor. Allocation concealment was preserved by password-protected OxMaR access managed by GT.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565298
Sponsor's protocol ID
240131002
Status last verified
Apr 2026
First submitted
16 Apr 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The small sample size of the study may limit the ability to fully ensure participant confidentiality if individual-level data were to be shared.

Publications

  • 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.

    PubMed 23651882
  • 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.

    PubMed 10380242
  • 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.

    PubMed 14613558
  • 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.

    PubMed 38047772
  • 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.

    PubMed 37516218
  • 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.

    PubMed 39270113

Questions about this trial

What is this clinical trial studying?

A study testing Pain neuroscience education (PNE) and Exercise program in people with Knee Osteoarthritis and Older Women, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 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 Chile. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KOOS - Activities of Daily Living (KOOS-ADL) (time frame: Baseline and immediately after the 10-week intervention period.). 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 NCT07565298, which also lists 6 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 4 May 2026.

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