search
Back to results

Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

Primary Purpose

Unilateral Primary Osteoarthritis of Knee

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Extracorporeal Shock Waves
Sham Extracorporeal Shock Waves
Physical activities
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Primary Osteoarthritis of Knee

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Extracorporeal Shock Waves

Sham Extracorporeal Shock Waves

Arm Description

Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks.

Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered.

Outcomes

Primary Outcome Measures

Knee Pain after one month
Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.

Secondary Outcome Measures

Knee pain progression
Mean change in VAS score one week after each application compared to baseline.
Knee Pain after three months
Mean change in VAS score three months after the end of the treatment compared to baseline.
Lequesne Knee Function progression
Mean change in Lequesne score one week after each application compared to baseline.
Lequesne Knee Function after three months
Mean change in Lequesne three months after the end of the treatment compared to baseline.
WOMAC Knee Function progression
Mean change in WOMAC score one week after each application compared to baseline.
TUG Knee Function progression
Mean change in TUG score one week after each application compared to baseline.
WOMAC Knee Function after three months
Mean change in WOMAC score three months after the end of the treatment compared to baseline.
TUG Knee Function after three months
Mean change in TUG score three months after the end of the treatment compared to baseline.

Full Information

First Posted
June 29, 2016
Last Updated
September 13, 2016
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02904785
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Primary Osteoarthritis of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal Shock Waves
Arm Type
Experimental
Arm Description
Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks.
Arm Title
Sham Extracorporeal Shock Waves
Arm Type
Sham Comparator
Arm Description
Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered.
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Waves
Intervention Type
Device
Intervention Name(s)
Sham Extracorporeal Shock Waves
Intervention Type
Other
Intervention Name(s)
Physical activities
Intervention Description
Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
Primary Outcome Measure Information:
Title
Knee Pain after one month
Description
Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Knee pain progression
Description
Mean change in VAS score one week after each application compared to baseline.
Time Frame
One week after each of four weekly ESWT applications
Title
Knee Pain after three months
Description
Mean change in VAS score three months after the end of the treatment compared to baseline.
Time Frame
Three months
Title
Lequesne Knee Function progression
Description
Mean change in Lequesne score one week after each application compared to baseline.
Time Frame
One week after each of four weekly ESWT applications
Title
Lequesne Knee Function after three months
Description
Mean change in Lequesne three months after the end of the treatment compared to baseline.
Time Frame
Three months
Title
WOMAC Knee Function progression
Description
Mean change in WOMAC score one week after each application compared to baseline.
Time Frame
One week after each of four weekly ESWT applications
Title
TUG Knee Function progression
Description
Mean change in TUG score one week after each application compared to baseline.
Time Frame
One week after each of four weekly ESWT applications
Title
WOMAC Knee Function after three months
Description
Mean change in WOMAC score three months after the end of the treatment compared to baseline.
Time Frame
Three months
Title
TUG Knee Function after three months
Description
Mean change in TUG score three months after the end of the treatment compared to baseline.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilson T Shinzato, MD
Phone
55-11-99688-0698
Email
g.shinzato@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Fabíola Cavalieri, MD
Phone
55-11-99212-3999
Email
fabiola.cavalieri@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linamara R Battistella, PhD, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
City
Sao Paulo
ZIP/Postal Code
04116-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabíola Cavalieri, MD
Phone
55-11-99212-3999
Email
fabiola.cavalieri@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Artur C Santos
Phone
55-11-5180-7897
Email
artur.santos@hc.fm.usp.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

We'll reach out to this number within 24 hrs