Trials / Completed
CompletedNCT03681613
Exercise Therapy in Combination With Central Nervous System-targeted Treatment for Osteoarthritis
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- University of Valencia · Academic / Other
- Sex
- All
- Age
- 41 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | NEMEX program combined with a CNS-focused protocol | 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. |
| OTHER | NEMEX program | 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. |
Timeline
- Start date
- 2019-01-07
- Primary completion
- 2022-08-30
- Completion
- 2022-08-30
- First posted
- 2018-09-24
- Last updated
- 2024-07-23
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03681613. Inclusion in this directory is not an endorsement.