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Clinical Trials/NCT03582644
NCT03582644
Completed
Not Applicable

Cryotherapy Effectiveness on Pain, Physical Function and Quality of Life in Individuals With End Stage Knee Osteoarthritis - a Case Series

Universidade Federal de Sao Carlos1 site in 1 country12 target enrollmentJune 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Universidade Federal de Sao Carlos
Enrollment
12
Locations
1
Primary Endpoint
Visual Analogue Scale (Pain scale)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 26, 2018
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Universidade Federal de Sao Carlos
Responsible Party
Principal Investigator
Principal Investigator

Lucas Ogura Dantas

Principal Investigator

Universidade Federal de Sao Carlos

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.

Outcomes

Primary Outcomes

Visual Analogue Scale (Pain scale)

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

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.

Secondary Outcomes

  • 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))
  • 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))
  • 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))
  • Pain catastrophizing scale(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))
  • 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))

Study Sites (1)

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