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

NCT03582644 | Completed

• 1 other identifier: CAAE: 81166517.7.0000.5504
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Cryotherapy; Physiotherapy; Physical Agent

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (Pain scale)

  VAS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be positioned in front of the individual and will have a range of 0 to 10 cm, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.

  Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

Secondary Outcomes (6)

• Western Ontario & McMaster Universities Osteoarthritis (WOMAC)

  Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

• 40m fast paced walk test

  Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

• 30-Second Chair to Stand Test

  Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

• Stair climb test

  Baseline assessment 1 (First week), Baseline assessment 2 (Second week), Baseline assessment 3 (Third Week), Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

• Short Form 36

  Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

Study Arms (1)

CRYOTHERAPY INTERVENTION

EXPERIMENTAL

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

Other: Cryotherapy

Interventions

Cryotherapy 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)

Also known as: Cold Therapy, Ice Therapy

CRYOTHERAPY INTERVENTION

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565905, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Cryotherapy; Ice

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Lucas O Dantas

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 11, 2018
• Study Start: June 26, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)