Clinical trial NCT02636764: Influence of Using Physical Therapy Resources for Knee Osteoarthritis
Official title: Influence of Using Physical Therapy Resources for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Physical Therapy Modalities
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: pain
timeFrame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
measure: stiffness
timeFrame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
measure: physical functional
timeFrame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Secondary outcomes:
measure: intensity of pain
timeFrame: Change from Baseline in The Numerical rating pain scale at 8 weeks
measure: Self-perceived fatigue
timeFrame: Change from Baseline in the self-perceived fatigue at 8 weeks
measure: Functional capacity for sitting and standing
timeFrame: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
measure: level of pressure pain
timeFrame: Change from Baseline in ThePressure Pain Threshold at 8 weeks
measure: Self-perceived fatigue
timeFrame: Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
state: São Paulo, São Paulo
Study officials:
affiliation: University of Nove de Julho
name: Cid André Fidelis de Paula Gomes, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.