Influence of Using Physical Therapy Resources for Knee Osteoarthritis (osteoarthritis)

• ClinicalTrials.gov Identifier: NCT02636764
• Recruitment Status: Completed
• First Posted: December 22, 2015
• Last Update Posted: February 19, 2018
• Sponsor: University of Nove de Julho
• Information provided by (Responsible Party): Cid André Fidelis de Paula Gomes, University of Nove de Julho

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Physical Therapy Modalities	Other: exercise; Device: interferential current; Device: short-wave diathermy; Device: Low level laser therapy; Device: Ultrasound therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Influence of Using Physical Therapy Resources for Knee Osteoarthritis
• Study Start Date: December 2016
• Actual Primary Completion Date: September 2017
• Actual Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: exercise group; An exercise protocol drawn up with the objective will be held to strengthen the musculature: flexor and extensor of the knee; extension, abduction, hip side rotator, using the weight and the elastic band.	Other: exercise; exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
Placebo Comparator: exercise group + Ultrasound therapy; Apart from intervening in the exercise group, an ultrasound device is used .	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: 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.
Experimental: exercise group + interferential current; Besides the intervention of the exercise group after the exercises will be applied to interferential current through the device. Will be positioned 4 electrodes (8x5 cm), two upper and two lower (forming a square) around the center of the knee.	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
Experimental: exercise group + short-wave diathermy; Besides the intervention of the exercise group after the exercises will be applied diathermies short wave in continuous mode. For that will be used apparatus, 27.12 megahertz, by means of vulcanized rubber electrodes (12x17 cm) with gentle warming for 30 minutes.	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: short-wave diathermy; Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
Experimental: exercise group + Low level laser therapy; Apart from intervening in the exercise group, will be applied to Low level laser therapy, through the laser unit, Class 3b, gallium-aluminum-arsenide, continuous mode, wavelength: 830 nanometer, power: 30 watts.	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: 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.

Outcome Measures

Primary Outcome Measures :

1. pain [ Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks ]
   The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
2. stiffness [ Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks ]
   The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
3. physical functional [ Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks ]
   The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

Secondary Outcome Measures :

1. intensity of pain [ Time Frame: Change from Baseline in The Numerical rating pain scale at 8 weeks ]
   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'.
2. Self-perceived fatigue [ Time Frame: Change from Baseline in the self-perceived fatigue at 8 weeks ]
   a visual analog scale (VAS-F).
3. Functional capacity for sitting and standing [ Time Frame: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks ]
   sitting-rising test
4. level of pressure pain [ Time Frame: Change from Baseline in ThePressure Pain Threshold at 8 weeks ]
   Pressure Pain Threshold in the knee with algometer dynamometer.
5. Self-perceived fatigue [ Time Frame: Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks ]
   The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

University of Nove de Julho

São Paulo, São Paulo, São Paulo, Brazil, 01504-001

Sponsors and Collaborators

University of Nove de Julho

Investigators

• Principal Investigator: Cid André Fidelis de Paula Gomes, Phd; University of Nove de Julho

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Paula Gomes CAF, Politti F, de Souza Bacelar Pereira C, da Silva ACB, Dibai-Filho AV, de Oliveira AR, Biasotto-Gonzalez DA. Exercise program combined with electrophysical modalities in subjects with knee osteoarthritis: a randomised, placebo-controlled clinical trial. BMC Musculoskelet Disord. 2020 Apr 20;21(1):258. doi: 10.1186/s12891-020-03293-3.

• Responsible Party: Cid André Fidelis de Paula Gomes, Phd, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT02636764
• Other Study ID Numbers: 51391715.1.0000.5511
• First Posted: December 22, 2015
• Last Update Posted: February 19, 2018
• Last Verified: February 2018

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases