A Phase 2 interventional study of Extracorporeal Radial shockwaves and Placebo Radial Shockwaves in Knee Osteoarthritis, sponsored by Marta Imamura. Completed at 2 sites in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by Marta Imamura · Phase 2, Interventional, and Treatment
The objective of this study is to compare the results of 2000 impulses of radius shockwaves per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of patients with severe primary knee osteoarthritis, who did not satisfactory respond to previous conventional treatments.
Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Switzerland), generated by pneumatic waves.
Intervention:
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Post application program for both groups: Three consecutive days of:
Outcome Evaluation:
The evaluation of pain intensity will be done according to the VAS (Visual Analog Scale) The influence of pain on the functional capacity of patients will be measured with WOMAC (Western Ontario and McMaster Osteoarthritis Index) for knee evaluation.
Another evaluation criteria will be the level of tolerance of pressure on several muscles and other parts as the pes anserinus and patellar tendon, the knee joint interface, and the supraspinal of L1 to S1 also on the dermatomal from T12 to S2. These measures will be done by the Fisher algometry.
The evaluations will be carried out before the treatment, immediately after the treatment and 3 months after the end of the treatment.
Analgesia drut will be prescribed, if patients feel pain during the days after the application.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 105 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Device: Extracorporeal Radial shockwaves
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Device: Placebo Radial Shockwaves
Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Visual Analog Scale
The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
Time frame: Before intervention and after 3 months of the end of intervention
Level of tolerance of pain
Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.
Time frame: Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
The influence of pain over the functional capacity of patients based on the WOMAC questionnaire
Time frame: Immediately before the intervention and 3 months after the intervention.
Plan to share: No
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Marta Imamura