Cryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series

NCT ID: NCT03582644

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2019-06-01

Brief Summary

The purpose of this case series will be to provide a detailed description of a standardized short-term cryotherapy application protocol using validated functional outcome measures in individuals with end stage KOA

Detailed Description

There are no studies determining the efficacy of cryotherapy in pain, function and quality of life for patients with end stage Knee Osteoarthritis (KOA). This case series describes a standardized treatment program for end stage patients with KOA and outcomes over a 12-week period.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRYOTHERAPY INTERVENTION

Patients with end stage knee osteoarthritis, both sexes, 60 years or higher

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: OTHER

Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton)

Interventions

Cryotherapy

Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton)

Intervention Type: OTHER

Other Intervention Names

Cold Therapy; Ice Therapy

Eligibility Criteria

Inclusion Criteria

• Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of American College of Rheumatology
• Osteoarthritis signals in at least one of the compartments of the knee joint (tibiofemoral and / or the patellofemoral joint)
• Do not perform regular physical activity
• Grade 4 according to the criteria of Kellgren & Lawrence knee osteoarthritis radiographic examination scale.
• Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
• Body Mass Index less or equal to 40 kg/cm2

Exclusion Criteria

• Physical therapy within 3 months prior to the research project
• Corticosteroid or Hyaluronic Acid injection in the knee (in the previous 6 months)
• Cardiorespiratory, neurological or other rheumatic dysfunctions associated with the diagnosis of knee osteoarthritis.
• Hip, knee or ankle surgery
• Any other type of chronic condition that can lead to pain.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Lucas Ogura Dantas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas O Dantas

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

Federal University of São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAAE: 81166517.7.0000.5504

Identifier Type: -

Identifier Source: org_study_id