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

27. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

19

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Chile
      • Santiago, Chile
        • Pontificia Universidad Catolica de Chile

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: Pain neuroscience education (PNE)
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.
Jiný: Exercise program
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.
Aktivní komparátor: 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.
Jiný: Exercise program
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
KOOS - Activities of Daily Living (KOOS-ADL)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
KOOS - Pain Subscale
Časové okno: 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.
KOOS - Symptoms Subscale
Časové okno: Baseline and immediately after the 10-week intervention period.
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.
Baseline and immediately after the 10-week intervention period.
KOOS - Sport and Recreation Function Subscale
Časové okno: Baseline and immediately after the 10-week intervention period.
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
Časové okno: Baseline and immediately after the 10-week intervention period.
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
Časové okno: Baseline and immediately after the 10-week intervention period.
Pain intensity was assessed with a 10-cm visual analog scale, with higher scores indicating greater pain intensity.
Baseline and immediately after the 10-week intervention period.
Lower-body functional performance
Časové okno: Baseline and immediately after the 10-week intervention period.
Lower-body functional performance was assessed with the 30-s Sit-to-Stand Test, scored as the number of repetitions completed in 30 seconds.
Baseline and immediately after the 10-week intervention period.
Pain neurophysiology knowledge
Časové okno: Baseline and immediately after the 10-week intervention period.
Pain neurophysiology knowledge was assessed with the Spanish version of the Revised Neurophysiology of Pain Questionnaire (R-NPQ), with higher scores indicating greater knowledge.
Baseline and immediately after the 10-week intervention period.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility - Screening and Recruitment
Časové okno: 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
From enrollment to the end of the 10-week intervention.
Feasibility - Retention
Časové okno: 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 (%)
From enrollment to the end of the 10-week intervention.
Feasibility - Exercise Adherence
Časové okno: From enrollment to the end of the 10-week intervention.
Exercise adherence defined as attendance at ≥80% of scheduled exercise sessions during the intervention period. Unit of Measure: Percentage of participants meeting adherence criterion (%)
From enrollment to the end of the 10-week intervention.
Feasibility - Attendance at Pain Neuroscience Education Sessions
Časové okno: From enrollment to the end of the 10-week intervention.
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
From enrollment to the end of the 10-week intervention.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pontificia Universidad Catolica de Chile

Vyšetřovatelé

  • Vrchní vyšetřovatel: Gustavo Torres, Pontificia Universidad Catolica de Chile

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. srpna 2024

Primární dokončení (Aktuální)

30. listopadu 2024

Dokončení studie (Aktuální)

30. listopadu 2024

Termíny zápisu do studia

První předloženo

16. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

27. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 240131002

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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