Clinical trial NCT02904785: Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis
Official title: The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unilateral Primary Osteoarthritis of Knee
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.

Detailed description: This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).

The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.

The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren \& Lawrence I, II or III);
* Capability to understand the Informed Consent Form;
* Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
* Absence of skin injures, infections or tumor in the target knee;
* Availability to comply with the visits.

Exclusion Criteria:

* History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
* History or onset neurological diseases;
* Generalized pain or fibromyalgia;
* Inability to walk;
* History of knee surgery in the target knee;
* Secondary causes of osteoarthritis;
* Use of statins and quinolones in the previous year;
* Uncontrolled and ongoing psychiatric diseases;
* Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.

Primary outcomes:
measure: Knee Pain after one month
timeFrame: One month
Secondary outcomes:
measure: Knee pain progression
timeFrame: One week after each of four weekly ESWT applications
measure: Knee Pain after three months
timeFrame: Three months
measure: Lequesne Knee Function progression
timeFrame: One week after each of four weekly ESWT applications
measure: Lequesne Knee Function after three months
timeFrame: Three months
measure: WOMAC Knee Function progression
timeFrame: One week after each of four weekly ESWT applications
measure: TUG Knee Function progression
timeFrame: One week after each of four weekly ESWT applications
measure: WOMAC Knee Function after three months
timeFrame: Three months
measure: TUG Knee Function after three months
timeFrame: Three months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
Study officials:
affiliation: University of Sao Paulo
name: Linamara R Battistella, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: