Exercise Therapy in Combination With Central Nervous System-targeted Treatment for Osteoarthritis

NCT03681613 | Completed

• 1 other identifier: H1526892955402
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate if exercise therapy comprising the NEMEX program in combination with a CNS-targeted treatment using GMI and SDT is superior to exercise therapy alone in improving self-reported pain, function, quality of life and objective measures related to hyperexcitability of the CNS (e.g. central sensitization) in people with KOA.

Conditions

Osteoarthritis; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• The Knee injury and Osteoarthritis Outcome Score subscales (KOOS4)

  The primary outcome is the between-group difference in change in the mean score on four Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales, covering pain, symptoms, activities of daily living, and quality of life (KOOS4). The four patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the four scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

  baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment

Secondary Outcomes (14)

• The Knee injury and Osteoarthritis Outcome Score (KOOS)

  baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment

• Pain intensity: NRS

  baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment

• Sensitivity to physical activity

  baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment

• General health

  baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment

• Cortical representation

  baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment

Study Arms (2)

Exercise Therapy With CNS Treatment

EXPERIMENTAL

NEMEX program combined with a CNS-focused protocol

Other: NEMEX program combined with a CNS-focused protocol

Exercise Therapy alone

EXPERIMENTAL

NEMEX program alone

Other: NEMEX program

Interventions

NEMEX program combined with a CNS-focused protocol OTHER

The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down. The CNS-targeted treatment will consist of 12-week individualized and supervised sessions applied once weekly. Each training session will last approximately 30 minutes and include three parts, which are further explained below: 1) discussion of the participant's knee pain experience from a pain neuroscience perspective, 2) graded SDT and 3) GMI training.

Also known as: Graded Motor Imagery, Sensory Discrimination Training, NEMEX program

Exercise Therapy With CNS Treatment

NEMEX program OTHER

The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.

Exercise Therapy alone

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic and radiographically-confirmed tibiofemoral KOA (e.g. Kellgren-Lawrence ≥2, scored by an orthopaedic surgeon, not scheduled for total knee replacement \[decision among other factors based on pain, function and radiographic severity.
• Diagnosis of KOA according to the EULAR classification criteria: adults aged \>40 years with usage-related knee pain, only short-lived (\<30min) morning stiffness, functional limitation (based on yes/no to the following question: Is your functional level reduced as compared to before your knee symptoms first started?) and one or more typical examination findings (crepitus, restricted movement, bony enlargement). The presence of this cluster correctly diagnosed 99% of cases with KOA.

You may not qualify if:

• Less than mild functional limitations (a score above 75 on a 0-100 worst to best scale in the Spanish version of the self-report questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living (ADL) and quality of life (QOL).
• Previous knee replacement or any other lower limb surgery in the affected knee within the previous 3 months.
• Fracture of the affected extremity within the previous 6 months.
• Initiation of opioid analgesia or any form of injection (i.e. corticosteroid, hyaluronic acid, platelet-rich plasma) for knee pain within the previous 30 days.
• Physical impairments unrelated to the knee that would prevent safe participation in exercise.
• Any comorbidity that prevents from participating in the interventions (e.g.uncontrolled hypertension, moderate to high risk for cardiac complications)
• Any skin or medical condition preventing tactile stimulation on the knee.
• Inability to comprehend and complete study assessments or comply with study instructions (e.g. illiteracy, cognitive or visual impairments).
• Inability to a priori attend or complete the proposed course of intervention and follow-up schedule.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (36)

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MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Enrique Lluch Girbés, PhD

  University of Valencia

  STUDY DIRECTOR

• Søren Thorgaard Skou, PhD

  University of Southern Denmark

  STUDY CHAIR

• Javier Peral Pérez, PhD student

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 24, 2018
• Study Start: January 7, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: July 23, 2024

Record last verified: 2023-06

Locations

ES (1)