Osteoarthritis, Knee Clinical Trial
Official title:
Radial Versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis : A Randomized Control Trial
NCT number | NCT03921749 |
Other study ID # | 17MMHIS195 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2019 |
Est. completion date | May 20, 2020 |
Radial versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis : A Randomized Control Trial
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 20, 2020 |
Est. primary completion date | April 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - people aged 45 years or more - subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology - subjects diagnosed with grade II or III OA during radiologicalexamination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA - subjects with tenderness in the medial tibial plateau area - subjects who had pain on one side of the knee. Exclusion Criteria: - patients with a history of spinal stenosis, evidence of neurologic disease by history or physical examination, or secondary causes of arthritis (inflammatory or metabolic) - those who had a surgical intervention or intra-articular injection in the affected knee in the previous 6 months - any contraindication to extracorporeal shock wave(pregnancy, cancer, coagulation disorders, inflammatory disease, pacemakers, or other electronic implants). |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale | The scores will be based on pain intensity, where 0 and 10 points represent an absence of pain and a maximal intensity level of pain, respectively. | The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy. | |
Secondary | Western Ontario and McMaster Universities Osteoarthritis Index | The WOMAC, a validated disease-specific self-reporting questionnaire, is an examination for evaluating OA symptoms. The index consists of five questions for severity of knee pain, two for stiffness, and 17 for limitations in physical function. The WOMAC score ranges from 0 (best) to 96 (worst), with high score representing worse symptom severity31. | (6MWT). The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy. | |
Secondary | Lequesne index | The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee. | The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy. | |
Secondary | Six-minute walk test (6MWT) | Mobility performance will be assessed with the Six-Minute Walk Test (6MWT). The 6MWT is a submaximal test of walking capacity.33 Participants will walk at a self- selected speed for 6 min on an indoor, 30 meter corridor or walkway with cones placed at the beginning and end of the 30 meter boundary to indicate turns, with the goal of traveling the maximum distance. Jogging and running will not be allowed. | The evaluation will be done before therapy sections, 1 week after and 8 weeks after 3rd section of therapy. | |
Secondary | Measurement of knee ROM | The assisted active ROM will be measured using a hand-held goniometry.Measurements of knee flexion and extension will be taken with patients lying supine on an examination couch. The fully extended knee is considered as the zero position, and the degrees of maximum flexion, maximum extension, and extension deficit, when present, will be recorded. A negative ROM score for extension indicated that the patient is unable to reach the zero position. The angle between maximum flexion and maximum extension will be described as the excursion range. | The evaluation will be done before therapy sections, 1 week after and 8 weeks after 3rd section of therapy. |
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