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Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02197962
First Posted: July 23, 2014
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Marta Imamura, University of Sao Paulo
  Purpose
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.

Condition Intervention Phase
Knee Osteoarthritis Device: Extracorporeal Radial shockwaves Device: Placebo Radial Shockwaves Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Marta Imamura, University of Sao Paulo:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: Before intervention and after 3 months of the end of intervention ]
    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.


Secondary Outcome Measures:
  • Level of tolerance of pain [ Time Frame: Immediately before the intervention, immediately after the intervention and 3 months after the intervention. ]
    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.


Other Outcome Measures:
  • The influence of pain over the functional capacity of patients based on the WOMAC questionnaire [ Time Frame: Immediately before the intervention and 3 months after the intervention. ]

Enrollment: 105
Study Start Date: May 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extracorporeal radial shockwaves
Patients will receive 2,000 impulses of extracorporeal 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.
Device: Extracorporeal Radial shockwaves
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.
Placebo Comparator: Placebo Radial Shockwaves
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.
Device: Placebo Radial Shockwaves
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197962


Locations
Brazil
Instituto de Ortopedia e Traumatologia HCFMUSP
Sao Paulo, Brazil, 05403-010
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Sao Paulo, Brazil, 05716-150
Sponsors and Collaborators
Marta Imamura
University of Sao Paulo
Investigators
Principal Investigator: Marta Imamura, MD Instituto de Medicina Fisica e Reabilitacao HCFMUSP
  More Information

Responsible Party: Marta Imamura, Medical Doctor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02197962     History of Changes
Other Study ID Numbers: Radial Shockwave
First Submitted: July 17, 2014
First Posted: July 23, 2014
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marta Imamura, University of Sao Paulo:
Osteoarthritis
Radial shockwaves

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases