Skip to main content
OpenTrials
Completed

NCT Number: NCT07565298

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Disability Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Older Women Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Católica de Chile

Santiago, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 program

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. KOOS - Symptoms Subscale

    Time frame: 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.

  3. KOOS - Sport and Recreation Function Subscale

    Time frame: 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.

  4. KOOS - Knee-related Quality of Life Subscale

    Time frame: 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.

  5. Pain intensity

    Time frame: 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.

  6. Lower-body functional performance

    Time frame: 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.

  7. Pain neurophysiology knowledge

    Time frame: 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.

Other outcomes

  1. 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

  2. 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 (%)

  3. Feasibility - Exercise Adherence

    Time frame: 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 (%)

  4. Feasibility - Attendance at Pain Neuroscience Education Sessions

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.