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Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343147
First Posted: April 27, 2011
Last Update Posted: March 5, 2014
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.
Information provided by (Responsible Party):
Carlo Bertolini, Catholic University of the Sacred Heart
  Purpose
Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA). Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal painful conditions. However, the efficacy of superficial heating is controversial. Furthermore, no clinical trials have yet directly compared the effects of these treatment modalities in knee OA. Hence, the purpose of the present study is to compare the effects of deep and superficial hyperthermia, induced via microwave diathermy and hot packs, respectively, on pain and function in patients with symptomatic knee OA.

Condition Intervention
Knee Osteoarthritis Other: Microwave diathermy Other: Superficial hyperthermia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Versus Superficial Heating in Patients With Knee Osteoarthritis: a Double-blind Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Carlo Bertolini, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • British Medical Research Council (BMRC) rating scale [ Time Frame: 6 months ]
  • Pain visual analogue scale (VAS) [ Time Frame: 6 months ]

Enrollment: 54
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Deep hyperthermia
Microwave diathermy
Other: Microwave diathermy
Deep tissue heating via microwave diathermy
Superficial hyperthermia
Hot packs
Other: Superficial hyperthermia
Superficial heating via hot pack application

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 years or older
  • Moderate, mono or bilateral knee osteoarthritis
  • Pain lasting for at least three weeks

Exclusion Criteria:

  • Inability or unwillingness to sign informed consent
  • Previous surgery on the affected knee
  • Intra-articular injections with steroids or hyaluronic acid in prior 6 months
  • Physical therapy for knee problems in prior 6 months
  • Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee
  • Chronic NSAID or steroid treatment
  • Cognitive or psychiatric disorders
  • Pregnancy or breastfeeding
  • Contraindications to hyperthermia (cancer in prior 2 years or active cancer treatment, local thrombosis, impaired arterial circulation, altered cutaneous thermal sensitivity, local infections or systemic acute infections, metal implants or prosthesis, severe osteoporosis
  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): NCT01343147


Locations
Italy
Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Carlo Bertolini, M.D. Catholic University of the Sacred Heart
  More Information

Publications:

Responsible Party: Carlo Bertolini, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01343147     History of Changes
Other Study ID Numbers: 533/10
First Submitted: April 26, 2011
First Posted: April 27, 2011
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Carlo Bertolini, Catholic University of the Sacred Heart:
Hyperthermia
Microwave diathermy
Hot packs
Pain
Physical function

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