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

  • Italy
      • Rome, Italy, 00168
        • Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics

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
Other: Microwave diathermy
Deep tissue heating via microwave diathermy
OTHER: Superficial hyperthermia
Hot packs
Other: Superficial hyperthermia
Superficial heating via hot pack application

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
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.

Sponsor

Catholic University of the Sacred Heart

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

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

Keywords

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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