Influence of Using Physical Therapy Resources for Knee Osteoarthritis

NCT02636764 | Completed DMC

• 1 other identifier: 51391715.1.0000.5511
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• intensity of pain

  Change from Baseline in The Numerical rating pain scale at 8 weeks

• Self-perceived fatigue

  Change from Baseline in the self-perceived fatigue at 8 weeks

• Functional capacity for sitting and standing

  Change from Baseline in The Functional capacity for sitting and standing at 8 weeks

• level of pressure pain

  Change from Baseline in ThePressure Pain Threshold at 8 weeks

• Self-perceived fatigue

  Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks

Study Arms (5)

exercise group

ACTIVE COMPARATOR

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

exercise group + Ultrasound therapy

PLACEBO COMPARATOR

Apart from intervening in the exercise group, an ultrasound device is used .

Other: exercise; Device: Ultrasound therapy

exercise group + interferential current

EXPERIMENTAL

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; Device: interferential current

exercise group + short-wave diathermy

EXPERIMENTAL

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; Device: short-wave diathermy

exercise group + Low level laser therapy

EXPERIMENTAL

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; Device: Low level laser therapy

Interventions

exercise OTHER

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

exercise group; exercise group + Low level laser therapy; exercise group + Ultrasound therapy; exercise group + interferential current; exercise group + short-wave diathermy

interferential current DEVICE

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

exercise group + interferential current

short-wave diathermy DEVICE

Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy

exercise group + short-wave diathermy

Low level laser therapy DEVICE

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.

exercise group + Low level laser therapy

Ultrasound therapy DEVICE

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.

exercise group + Ultrasound therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

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

Location

Related Publications (1)

• 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.

  PMID: 32312265 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise; Electric Stimulation Therapy; Low-Level Light Therapy; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Rehabilitation; Laser Therapy; Phototherapy; Diathermy; Hyperthermia, Induced

Study Officials

• Cid André Fidelis de Paula Gomes, Phd

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

BR (1)