Randomized Controlled Trial of Exercise Therapy in Combination With Central Nervous System-targeted Treatment Compared With Exercise Therapy Alone for Treatment of People With Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 121
- Locations
- 2
- Primary Endpoint
- The Knee injury and Osteoarthritis Outcome Score subscales (KOOS4)
Study Overview
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.
Detailed Description
Participants will be randomized to one of two treatments initiated after randomization: the NEMEX program combined with a CNS-focused protocol or the NEMEX program alone.
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 twice 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 41 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The Knee injury and Osteoarthritis Outcome Score subscales (KOOS4)
Time Frame: baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment
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.
Secondary Outcomes
- Cortical representation(baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
- 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)
- Pressure pain thresholds(baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
- Central Sensitization Inventory(baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
- Conditioned Pain Modulation(baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
- Number of participants with adverse events and number of adverse events(During follow-up)
- Number of chair stands in 30 seconds(Baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
- Global perceived effect, patient acceptable symptom state and treatment failure(12 months after initiating the treatment)
- Knee flexor and extensor strength(Baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
- Compliance, exercise level/intensity and other treatments received during the study(Up to 12 weeks)
- 40 m fast-paced walk test(Baseline, post-intervention (after 12 weeks) and 6 and 12 months after initiating the treatment)
Investigators
Enrique Lluch Girbés
PhD Professor
University of Valencia