Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlo Bertolini, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01343147
First received: April 26, 2011
Last updated: March 4, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • British Medical Research Council (BMRC) rating scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Pain visual analogue scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 26, 2011
Last Updated: March 4, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 28, 2014