Cryotherapy Associated With Exercise in Pain Control and Physical Function in Individuals With Knee Osteoarthritis

NCT03360500 | Completed

• 1 other identifier: CRYO-1234
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to verify the effect of cryotherapy associated with an exercise protocol in pain control, function and quality of life in individuals with knee osteoarthritis

Conditions

Osteoarthritis,Knee

Keywords

Osteoarthritis, Knee; Cryotherapy; Exercise; Physiotherapy; Knee

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation

  A visual analog scale (VAS) will be applied to measure the pain before and 1 day after the intervention. 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.

  The first measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

Secondary Outcomes (5)

• WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation

  The second measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

• 36-Item Short Form Survey

  The third measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

• Fast paced test in 40m test: Change values from the pre evaluation to the post evaluation

  The fourth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

• Stair test: Change values from the pre evaluation to the post evaluation

  The fifth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

• 30 seconds chair stand test: Change values from the pre evaluation to the post evaluation

  The sixth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

Study Arms (3)

EXERCISE PROTOCOL + CRYOTHERAPY

EXPERIMENTAL

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Other: EXERCISE PROTOCOL + CRYOTHERAPY

EXERCISE PROTOCOL

EXPERIMENTAL

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Other: EXERCISE PROTOCOL

EXERCISE PROTOCOL + PLACEBO

PLACEBO COMPARATOR

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Other: EXERCISE PROTOCOL + PLACEBO

Interventions

EXERCISE PROTOCOL + CRYOTHERAPY OTHER

Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises. Cryotherapy: Crushed ice inside two plastic bags. 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.

EXERCISE PROTOCOL + CRYOTHERAPY

EXERCISE PROTOCOL OTHER

Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises.

EXERCISE PROTOCOL

EXERCISE PROTOCOL + PLACEBO OTHER

Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises. Placebo: Sand inside two plastic bags. The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sandbags, they will be fixed with an elastic bandage (compression). All the knee surface will be covered with a moistened operative field.

EXERCISE PROTOCOL + PLACEBO

Eligibility Criteria

• Age: 40 Years - 75 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
• Grade 2 or 3 according to the criteria of Kellgren \& Lawrence knee osteoarthritis radiographic examination scale.
• Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
• Medical prescription, showing that the participant is capable of performing physical activities

You may not qualify if:

• Physical therapy within 3 months prior to the research project
• Corticosteroid injection in the knee (in the previous 6 months)
• Medical condition (cardiorespiratory, neurological and / or musculoskeletal)
• Previous ankle, knee or hip surgery

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal University of Sao Carlos

São Carlos, São Paulo, 251, Brazil

Location

Related Publications (2)

• French HP, Abbott JH, Galvin R. Adjunctive therapies in addition to land-based exercise therapy for osteoarthritis of the hip or knee. Cochrane Database Syst Rev. 2022 Oct 17;10(10):CD011915. doi: 10.1002/14651858.CD011915.pub2.

  PMID: 36250418 DERIVED

• Ogura Dantas L, Serafim Jorge AE, Regina Mendes da Silva Serrao P, Aburquerque-Sendin F, de Fatima Salvini T. Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial. BMJ Open. 2020 Jun 1;10(6):e035610. doi: 10.1136/bmjopen-2019-035610.

  PMID: 32482668 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lucas O Dantas, PhD Student

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

• Julya M Perea, Bachelors

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: March 26, 2018
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)