- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02919020
Efficacy of Proprioceptive Neuromuscular Facilitation in Older Women With Gonarthrosis (PNF)
July 17, 2021 updated by: Thaís Ferreira Lopes Diniz Maia, Universidade Federal de Pernambuco
Efficacy of Proprioceptive Neuromuscular Facilitation About Functional Performance, Pain and Quality of Life in Older Women With Gonarthrosis: Randomized Controlled Trial
To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF) as physical therapy approach to the reduction of pain and improvement in functional performance and quality of life in women with knee osteoarthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be divided into two groups: group perform proprioceptive neuromuscular facilitation and other group submit performing resistance exercises.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Petrolina, Pernambuco, Brazil, 50710430
- Hospital Universitário Drº Washigton Antônio de Barros
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women;
- Age between 50 and 80 years;
- Clinical diagnosis of Osteoarthritis of knees ;
- Patients with presence of at least 90 ° range of motion of knee flexion ;
- Do not practitioners of physical exercise and physical therapy during the period of participation in the survey
Exclusion Criteria:
- Diagnosis of other rheumatological and neurological diseases ;
- orthopedic surgery History in the lower limbs ;
- Individuals with muscle strength of the lower limbs <3 ;
- Cognitive impairment or neurological disease that compromises the understanding and implementation of the Protocol (Mini Mental State Examination <18 for the illiterate and <24 for others);
- Body mass index ≥ 30.0 (obesity , according to the World Health Organization ) .
- Individuals classified as physical activity level "very active" by the IPAQ (International Physical Activity Questionnaire ) .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proprioceptive neuromuscular facilitation (PNF);
Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members
|
Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members
|
Experimental: resistance exercise
Resistance exercise to strengthen lower limbs
|
resistance exercise to strengthen lower limbs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain
Time Frame: "change from baseline in pain 6th - 12th week"
|
"Pain control diary"
|
"change from baseline in pain 6th - 12th week"
|
Quality of life
Time Frame: change from baseline in quality of life 6th-12th week
|
Western Ontario and McMaster Universities Questionaire
|
change from baseline in quality of life 6th-12th week
|
Functional performance
Time Frame: Change based on functional performance 6th - 12th week
|
"30 s -chair stand test"
|
Change based on functional performance 6th - 12th week
|
Quality of life
Time Frame: Change based on functional performance 6th - 12th week
|
Medical Outcomes Study 36 - Item Short - Form Health Survey
|
Change based on functional performance 6th - 12th week
|
Functional Performance
Time Frame: Change based on functional performance 6th - 12th week
|
"Walk Test of 40 meters at a rapid pace
|
Change based on functional performance 6th - 12th week
|
Functional Performance
Time Frame: "Walk Test of 40 meters at a rapid pace
|
"Stair climb test"
|
"Walk Test of 40 meters at a rapid pace
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain sensitivity threshold
Time Frame: change from baseline in pain threshold 6th-12th week pressure
|
"Algometry"
|
change from baseline in pain threshold 6th-12th week pressure
|
Range of motion
Time Frame: "change from baseline in the range of knee flexion 6th-12th week"
|
"Universal Goniometer"
|
"change from baseline in the range of knee flexion 6th-12th week"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Daniella A Oliveira, Universidade Federal de Pernambuco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
September 24, 2016
First Submitted That Met QC Criteria
September 28, 2016
First Posted (Estimate)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 17, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECR2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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