Clinical trial NCT03582644: Cryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series
Official title: Cryotherapy Effectiveness on Pain, Physical Function and Quality of Life in Individuals With End Stage Knee Osteoarthritis - a Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Cryotherapy
Physiotherapy
Physical Agent
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale (Pain scale)
timeFrame: 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:
measure: Western Ontario & McMaster Universities Osteoarthritis (WOMAC)
timeFrame: Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
measure: 40m fast paced walk test
timeFrame: Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
measure: 30-Second Chair to Stand Test
timeFrame: Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
measure: Stair climb test
timeFrame: 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)
measure: Short Form 36
timeFrame: Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
measure: Pain catastrophizing scale
timeFrame: Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Lucas O Dantas
role: PRINCIPAL_INVESTIGATOR
References: