Influence of Using Physical Therapy Resources for Knee Osteoarthritis

Osteoarthritis Clinical Trial

— osteoarthritis  

Official title:

Influence of Using Physical Therapy Resources for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636764
• Other study ID #: 51391715.1.0000.5511
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: February 15, 2018
• Start date: December 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis is a chronic, multifactorial characterization, which changes in bone alignment, cartilage and structures that provide joint stability appear to be strongly correlated with the origin of this disease.This project will aim to verify the effectiveness of interferential current, short wave and low level laser therapy on an exercise program for mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups: exercise group, exercise group + Ultrasound therapy, exercise group + interferential current, exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and after the trial protocol by the following instruments: Western Ontario and McMaster Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical agents in an exercise program will provide an improvement in pain, mobility and knee function in individuals diagnosed with knee osteoarthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• knee pain to at least six months and minimum of 4 points in pain scale

• Diagnosed with osteoarthritis in unilateral knee according to the criteria established by the American College of Rheumatology and confirmed by radiographic examination for identification Kellgren-Lawrence grade 2 or 3 (Kellgren & Lawrence, 1957).

Exclusion Criteria:

• Any type of physical therapy

• therapy with intra-articular corticosteroids or therapeutic chondroprotective drugs last year, before the start of the study.

• history of trauma on his knees, cognitive disorder or psychological disorder,

• neurological (sensory or motor)

• cancer

• diabetes,

• or any state of adverse acute health osteoarthritis signs of hip

• cardiopulmonary disease that prevents the conducting exercises

• require auxiliary device for performing gait.

• Yet who undertake physical activity in the last two months. Physical activity is defined as strength training and / or more than 20 minutes of aerobic activity twice a week.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Physical Therapy Modalities

Intervention

Other:
• exercise
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Device:
• interferential current
The basic principle of Interferential Therapy (IFT) is to utilise the significant physiological effects of low frequency (<250pps) electrical stimulation of nerves without the associated painful and somewhat unpleasant side effects sometimes associated with low frequency stimulation
• short-wave diathermy
Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
• Low level laser therapy
Laser treatment in which the energy output is low enough so that the temperature of the treated tissue does not rise above 98.6°F (36.5° C) or normal body temperature.
• Ultrasound therapy
Ultrasound (US) is a form of mechanical energy, not electrical energy and therefore strictly speaking, not really electrotherapy at all but does fall into the Electro Physical Agents grouping.

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	São Paulo	São Paulo, São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Primary	stiffness	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Primary	physical functional	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Secondary	intensity of pain	The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.	Change from Baseline in The Numerical rating pain scale at 8 weeks
Secondary	Self-perceived fatigue	a visual analog scale (VAS-F).	Change from Baseline in the self-perceived fatigue at 8 weeks
Secondary	Functional capacity for sitting and standing	sitting-rising test	Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
Secondary	level of pressure pain	Pressure Pain Threshold in the knee with algometer dynamometer.	Change from Baseline in ThePressure Pain Threshold at 8 weeks
Secondary	Self-perceived fatigue	The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).	Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks

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