Unilateral Knee Osteoarthritis Clinical Trial
— ISOGOOfficial title:
Assessing the Impact of Isokinetic Muscular Strengthening in Eccentric Mode in the Medical Treatment of Knee Osteoarthritis.
| Verified date | January 2013 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises. Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode. The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Patient male or female, age ranging from 40 to 70 years old - Patient suffering from one-sided knee O.A. regarding criteria of the American College of Rheumatology (A.C.R.), with radiologic score ranging from 2 to 3 according to the Kellgren & Lawrence classification. - Patient receiving medical support - Patient that did not receive any infiltration on knee within two months before randomisation. - Patient free from any disease that could be a contraindication to the study treatment - Patient able to understand the protocol and willing to comply with its rules. - Patient willing to give consent. - Patient affiliated to the french social secu Exclusion Criteria: - Patient carrying prosthesis. - Patient suffering from inflammatory arthritis, or flare of arthritis. - Patient suffering from symptomatic patellofemoral osteoarthritis. - Patient suffering from cardio-vascular or pneumologic disease that could a contraindication to the study treatment. - Patient suffering from any pathology that could cause muscular weakness (myopathy, neuropathy, hemiplegia...) |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference of peak torque of quadriceps | 6 months after treatment start | ||
| Secondary | Walk speed (50 meters and 200 meters) | at day 1, 6 weeks, and 6 months : | ||
| Secondary | Knee pain (via analogic visual scales) | at day 1, 6 weeks, and 6 months | ||
| Secondary | Posture parameters (posturography) | at day 1, 6 weeks, and 6 months | ||
| Secondary | WOMAC Scores | at day 1, 6 weeks, and 6 months | ||
| Secondary | Knee perimeter | at day 1, 6 weeks, and 6 months | ||
| Secondary | Knee range of motion (goniometer) | at day 1, 6 weeks, and 6 months | ||
| Secondary | Kellgren & Lawrence scores | at day 1, 6 weeks, and 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01806207 -
Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis
|
Phase 4 |