Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis

NCT06482970 | Not Yet Recruiting

• 1 other identifier: 23-02
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

A three-arm randomized controlled trial will be conducted. Fifty-nine participants with KOA will be recruited in a 1:1:1 ratio. Assessor, and statistician will be blinded to group allocation. One experimental group (n=19) will receive NME plus PNE, the other experimental group (n=19) will receive isolated NME and the control group (n=19) will continue with usual care. The PNE will be adapted to the context of the participants. Outcome measures will be brain activity, pressure pain threshold, pain intensity, disability, fear-avoidance beliefs, self-efficacy, and pain catastrophizing. Outcome measures will be evaluated pre-intervention, immediately post-intervention, and four-month post-intervention. The investigators hypothesize that there will be significant differences in favor of the NME plus PNE intervention group.

Conditions

Knee Osteoarthritis

Keywords

Neuromuscular exercise; Pain neuroscience education; Knee osteoarthritis; Chronic pain; Physical therapy

Outcome Measures

Primary Outcomes (2)

• Brain function (peak frequency)

  An analysis of the peak frequencies (the highest power frequency determined in the average of the windows as the local maximum (greater than its two neighboring windows) of the amplitude in a frequency range of 6-14 Hz will be applied.

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

• Brain function (power spectrum)

  A global analysis of the power spectrum will be carried out, considered as the average of all the electrodes, which represents the synchronization between the neurons to generate the discharges. A topographic power analysis will also be performed for the Delta (0.1 - 4 Hz), theta (4 - 8 Hz), alpha (8 - 13 Hz) and beta (13 - 30 Hz) frequency bands.

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

Secondary Outcomes (6)

• Pain pressure-threshold

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

• Pain intensity

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

• Disability

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

• Fear-avoidance beliefs

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

• Self-efficacy

  baseline, post-intervention (2 months after admission), follow-up four months after the intervention.

Study Arms (3)

Neuromuscular exercise plus Pain neuroscience education

EXPERIMENTAL

Neuromuscular exercise will be carried out for eight weeks, with three weekly sessions, in groups (up to five participants per group). Each session will consist of three parts: warm-up, exercise circuit and cool down. Each part will be regulated for the abilities of the participants Pain neuroscience education will be carried in group using visual support for Powerpoint presentations. The PNE will include five dimensions with a focus on reducing fear-avoidance beliefs and catastrophic thoughts to promote self-efficacy. Five PNE sessions will be carried out, one for each dimension, with a duration of 30-45 minutes each taught during the first five sessions of the intervention. In addition, a brochure will be delivered with the main points of each of the domains and an informative video will be made to which participants will have access (five 15-minute videos, one per domain).

Other: Neuromuscular exercise plus pain neuroscience education

Neuromuscular exercise

EXPERIMENTAL

Neuromuscular exercise will be carried out for eight weeks, with three weekly sessions, in groups (up to five participants per group). Each session will consist of three parts: warm-up, exercise circuit and cool down. Each part will be regulated for the abilities of the participants

Other: Neuromuscular exercise

Usual care

NO INTERVENTION

Participants will be urged to continue with their life activities without changes. All participants will continue to receive routine care offered by their doctor and other health care providers. No trial interventions were provided. The possible treatments that may be provided to the participants in this group (if the primary medical team deems it appropriate) will not be influenced. However, if the participants receive any treatment from their medical staff, it will be recorded as an extra history and the participant will not be considered in the analyses. All participants in this group will be eligible to receive the experimental therapies of their choice once the study is completed.

Interventions

Neuromuscular exercise plus pain neuroscience education OTHER

The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability). Pain neuroscience education will take an active, person-centered approach through their own fear-avoidance beliefs.

Neuromuscular exercise plus Pain neuroscience education

Neuromuscular exercise OTHER

The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability).

Neuromuscular exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women and men at least 45 years old radiologically diagnosed with unilateral or bilateral KOA (Kellgren-Lawrence 1-3 grading scale)
• pain duration greater than three months

You may not qualify if:

• Patients who have received physical therapy or other conservative therapy in the previous three months and those who have a history of major knee trauma and surgery in the last six months
• cardiac pathology
• structural use of psychoactive medications, such as antipsychotics, antidepressants, antiepileptics, and anxiolytics, during the past year
• neurological diseases
• other musculoskeletal clinical conditions that generate pain

Sponsors & Collaborators

• Universidad Santo Tomas, Chile: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Joaquín I Salazar, MSc

  Universidad Santo Tomás

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquín I Salazar, MSc

CONTACT

+569 73785287; jsalazar13@santotomas.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 1, 2024
• Study Start: March 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from 6 months after publication. They will be available for one year
• Access Criteria: will be provided to any researcher who requires it via email