Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

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. Identifier: NCT01343147
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
Carlo Bertolini, Catholic University of the Sacred Heart

Brief Summary:
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 or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Microwave diathermy Other: Superficial hyperthermia Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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

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

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 identifier (NCT number): NCT01343147

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


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

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

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