Clinical Trials Directory

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

TypeNameDescription
OTHERNEMEX program combined with a CNS-focused protocolThe 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.
OTHERNEMEX programThe 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.