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Effect of intervention with exercises and pain neuroscience education on physical, cognitive, and emotional function and gait parameters of elderly people with and without knee osteoarthritis: a randomized clinical trial

Effect of intervention with multicomponent exercises and pain neuroscience education on physical, cognitive, psychoemotional function and gait parameters of elderly individuals with and without Knee osteoarthritis: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10wjzrt7
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other primary gonarthrosis

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Experimental group: 25 elderly (women and male) with knee osteoarthritis (grades 2 or 3) who will receive a multicomponent therap

Sponsors

Obras Socias e Educacionais de Luz
Lead Sponsor
Universidade Santo Amaro
Collaborator

Eligibility

Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 60 and 80 years; female and masculine gender; diagnosis of Medial Femorotibial Osteoarthritis confirmed by X-ray examination; grade 2 or 3 Knee Osteoarthritis according to the Kellgren and Lawrence criteria

Exclusion criteria

Exclusion criteria: Diagnosis of Osteoarthritis in the Hip and/or Ankle; grade 4 Osteoarthritis in one or both knees; body mass index less than 35 kg/m²; presence of Vestibulocochlear Diseases; uncontrolled Cardiac or Respiratory Arrhythmias; Convulsive Syndrome; Musculoskeletal Disorders with functional limitation, such as Diabetic Neuropathies and Cutaneous Ulcers of any etiology; use of Prostheses or Orthoses in the lower limbs; Fractures in the last six months; presence of Dementia; inability to Walk independently; being under Physical Therapy treatment concurrently with the intervention period

Design outcomes

Primary

MeasureTime frame
Assess pain intensity, determined by the Visual Analog Scale at baseline and end of study. Expect a mean reduction in pain of at least 2 cm.;Assess functionality, as determined by the Lequesne and WOMAC algofunctional questionnaires, at baseline and end of study. A mean reduction of 10% in questionnaire scores is expected.

Secondary

MeasureTime frame
Assess gait performance using the six-minute walk test at baseline and end of the study. An average 10% increase in walking speed is expected.;Assess the risk of falls, as determined by the Falls Risk Awareness Questionnaire-FRAQ-Brazil (FRAQ) at baseline and end of the study. An average increase of 10% in the total score is expected.;Assess physical performance using the Timed Up & Go Test (TUG), Chester Step Test, and Floor Transfer Test at baseline and end of the study. An average 10% increase is expected.;Assess physical activity, as determined by the International Physical Activity Questionnaire (IPAQ), at baseline and end of the study. An average 10% increase in these scores is expected.;Assess foot function, as determined by the Foot Function Index (FFI) questionnaire at baseline and end of the study. An average 10% increase in these scores is expected.;Assess plantar pressure and body sway (balance) determined by the pressure platform at baseline and end of the study. A mean reduction in plantar pressure and sway of 15% is expected.;Assess pain knowledge, as determined by the Neurophysiology of Pain questionnaire, at baseline and end of the study. A mean increase in pain knowledge of 15% is expected.;Assess psycho-emotional factors, determined by the catastrophizing scale, the Tampa scale, and pain perception, at baseline and end of the study. A mean reduction in psycho-emotional factors of 15% is expected.;Assess the overall effect of the intervention, as determined by the acceptability, suitability, feasibility, and patient satisfaction questionnaire at baseline and end of study. An average acceptability of 50% is expected.

Countries

Brazil

Contacts

Public ContactAna Paula Ribeiro

Universidade Santo Amaro

anapribeiro@prof.unisa.br+55-11-2141-8640

Outcome results

None listed

Source: REBEC (via WHO ICTRP)