Clinical trial NCT03344770: The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis
Official title: The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis.

For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week.

Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy.

Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis;
* Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) \> 4;
* Onset knee pain over 3 months prior to the inclusion;

Exclusion Criteria:

* Presence of psychiatric disease;
* Presence of fibromyalgia;
* Presence of systemic inflammatory rheumatic diseases;
* History of neoplasia;
* Presence of clinical diseases in other joints;
* Ongoing use of anticoagulant drugs.

Primary outcomes:
measure: Functional Change
timeFrame: At baseline and three months after the end of the treatment.
Secondary outcomes:
measure: Short Term Functional Changes
timeFrame: At baseline and one week after the end of the treatment.
measure: Knee pain reduction
timeFrame: At baseline, one week and three months after the end of the treatment
measure: Pain pressure threshold tolerance changes
timeFrame: At baseline, one week and three months after the end of the treatment
measure: Diffuse noxious inhibitory control alterations
timeFrame: At baseline, one week and three months after the end of the treatment
measure: Thermography evaluation
timeFrame: At baseline, one week and three months after the end of the treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Study officials:
affiliation: Instituto de Medicina Física e Reabilitação HCFMUSP
name: Marta Imamura, MD
role: PRINCIPAL_INVESTIGATOR
References: