- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343147
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis
March 4, 2014 updated by: Carlo Bertolini, Catholic University of the Sacred Heart
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis: a Double-blind Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rome, Italy, 00168
- Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Deep hyperthermia
Microwave diathermy
|
Deep tissue heating via microwave diathermy
|
OTHER: Superficial hyperthermia
Hot packs
|
Superficial heating via hot pack application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)
Time Frame: 12 months
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
British Medical Research Council (BMRC) rating scale
Time Frame: 6 months
|
6 months
|
Pain visual analogue scale (VAS)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carlo Bertolini, M.D., Catholic University of the Sacred Heart
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Giombini A, Giovannini V, Di Cesare A, Pacetti P, Ichinoseki-Sekine N, Shiraishi M, Naito H, Maffulli N. Hyperthermia induced by microwave diathermy in the management of muscle and tendon injuries. Br Med Bull. 2007;83:379-96. doi: 10.1093/bmb/ldm020.
- Di Cesare A, Giombini A, Dragoni S, Agnello L, Ripani M, Saraceni VM, Maffulli N. Calcific tendinopathy of the rotator cuff. Conservative management with 434 Mhz local microwave diathermy (hyperthermia): a case study. Disabil Rehabil. 2008;30(20-22):1578-83. doi: 10.1080/09638280701786351.
- Giombini A, Di Cesare A, Safran MR, Ciatti R, Maffulli N. Short-term effectiveness of hyperthermia for supraspinatus tendinopathy in athletes: a short-term randomized controlled study. Am J Sports Med. 2006 Aug;34(8):1247-53. doi: 10.1177/0363546506287827. Epub 2006 Apr 24.
- Kaplan LD, Chu CR, Bradley JP, Fu FH, Studer RK. Recovery of chondrocyte metabolic activity after thermal exposure. Am J Sports Med. 2003 May-Jun;31(3):392-8. doi: 10.1177/03635465030310031101.
- Weinberger A, Fadilah R, Lev A, Levi A, Pinkhas J. Deep heat in the treatment of inflammatory joint disease. Med Hypotheses. 1988 Apr;25(4):231-3. doi: 10.1016/0306-9877(88)90036-9.
- Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.
- Robertson VJ, Ward AR, Jung P. The effect of heat on tissue extensibility: a comparison of deep and superficial heating. Arch Phys Med Rehabil. 2005 Apr;86(4):819-25. doi: 10.1016/j.apmr.2004.07.353.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
April 26, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (ESTIMATE)
April 27, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 5, 2014
Last Update Submitted That Met QC Criteria
March 4, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 533/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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