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

NCT07565298 | Completed

• 1 other identifier: 240131002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis; Older Women; Pain; Disability

Keywords

Pain Neuroscience Education; Knee Osteoarthritis; Older Women; Disability; Exercise; Pilot randomized controlled trial

Outcome Measures

Primary Outcomes (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.

  Baseline and immediately after the 10-week intervention period.

Secondary Outcomes (7)

• KOOS - Pain Subscale

  Baseline and immediately after the 10-week intervention period.

• KOOS - Symptoms Subscale

  Baseline and immediately after the 10-week intervention period.

• KOOS - Sport and Recreation Function Subscale

  Baseline and immediately after the 10-week intervention period.

• KOOS - Knee-related Quality of Life Subscale

  Baseline and immediately after the 10-week intervention period.

• Pain intensity

  Baseline and immediately after the 10-week intervention period.

Other Outcomes (4)

• Feasibility - Screening and Recruitment

  From enrollment to the end of the 10-week intervention.

• Feasibility - Retention

  From enrollment to the end of the 10-week intervention.

• Feasibility - Exercise Adherence

  From enrollment to the end of the 10-week intervention.

Study Arms (2)

Exercise plus Pain Neuroscience Education

EXPERIMENTAL

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.

Other: Pain neuroscience education (PNE); Other: Exercise program

Exercise-only group

ACTIVE COMPARATOR

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.

Other: Exercise program

Interventions

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 plus Pain Neuroscience Education

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.

Exercise plus Pain Neuroscience Education; Exercise-only group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Medical diagnosis of knee osteoarthritis with current knee pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Related Publications (6)

• 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.

  PMID: 23651882 BACKGROUND

• 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.

  PMID: 10380242 BACKGROUND

• 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.

  PMID: 14613558 BACKGROUND

• 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.

  PMID: 38047772 BACKGROUND

• 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.

  PMID: 37516218 BACKGROUND

• 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.

  PMID: 39270113 BACKGROUND

Related Links

• The Knee Osteoarthritis Handbook (Noigroup©)
• Dolor Crónico, una guía de ayuda para pacientes (Equipo DolorUC book)

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gustavo Torres

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 4, 2026
• Study Start: August 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CL (1)