Clinical trial NCT02197962: Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
Official title: Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Radial shockwaves
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2014-07-23
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of primary knee diagnosis.
* Pain intensity: Visual Analog Scale (VAS) ≥ 6;
* One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
* Age over 60 years;
* No use of corticosteroids in the prior 48 hours;
* No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
* No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
* Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
* Absence of infection or cancer at the application site;
* Absence of related endocrine and metabolic diseases;
* Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
* Absence of severe blood dyscrasias;
* Absence of severe psychiatric disturbances that requires psychiatric assessment;
* Availability to comply with the clinic visits and follow up evaluations along the treatment

Exclusion Criteria:

* Patients who withdraw the informed consent form at any time

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before intervention and after 3 months of the end of intervention
Secondary outcomes:
measure: Level of tolerance of pain
timeFrame: Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
Other outcomes:
measure: The influence of pain over the functional capacity of patients based on the WOMAC questionnaire
timeFrame: Immediately before the intervention and 3 months after the intervention.
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia HCFMUSP
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Study officials:
affiliation: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
name: Marta Imamura, MD
role: PRINCIPAL_INVESTIGATOR
References: