Back to resultsDeep Versus Superficial Heating in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Microwave diathermy
Superficial hyperthermia
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Hyperthermia, Microwave diathermy, Hot packs, Pain, Physical function
Eligibility 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
Sites / Locations
- Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Deep hyperthermia
Superficial hyperthermia
Arm Description
Microwave diathermy
Hot packs
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)
Secondary Outcome Measures
British Medical Research Council (BMRC) rating scale
Pain visual analogue scale (VAS)
Full Information
NCT ID
NCT01343147
First Posted
April 26, 2011
Last Updated
March 4, 2014
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01343147
Brief Title
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis
Official Title
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis: a Double-blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Hyperthermia, Microwave diathermy, Hot packs, Pain, Physical function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep hyperthermia
Arm Type
Other
Arm Description
Microwave diathermy
Arm Title
Superficial hyperthermia
Arm Type
Other
Arm Description
Hot packs
Intervention Type
Other
Intervention Name(s)
Microwave diathermy
Intervention Description
Deep tissue heating via microwave diathermy
Intervention Type
Other
Intervention Name(s)
Superficial hyperthermia
Intervention Description
Superficial heating via hot pack application
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
British Medical Research Council (BMRC) rating scale
Time Frame
6 months
Title
Pain visual analogue scale (VAS)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Bertolini, M.D.
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17942453
Citation
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.
Results Reference
background
PubMed Identifier
18608369
Citation
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.
Results Reference
background
PubMed Identifier
16636345
Citation
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.
Results Reference
background
PubMed Identifier
12750132
Citation
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.
Results Reference
background
PubMed Identifier
3367814
Citation
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.
Results Reference
background
PubMed Identifier
18496246
Citation
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.
Results Reference
background
PubMed Identifier
15827938
Citation
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.
Results Reference
background
Learn more about this trial
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis
We'll reach out to this number within 24 hrs