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.
* Prospective, placebo controlled randomized and double-blind study. * Treatment Method: Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Switzerland), generated by pneumatic waves. Intervention: * Group 1 - Intervention group Patients will receive 2,000 impulses of 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. * Group 2 - Control Group: 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: 1. Hot packs (superficial heat) applied on the application site for 20 minutes; 2. Simple analgesics, when needed (Acetaminophen 500mg every 6 hours, or analogue in case of allergy). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
105
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.
Instituto de Ortopedia e Traumatologia HCFMUSP
São Paulo, São Paulo, Brazil
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, São Paulo, Brazil
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.
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