search
Back to results

Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise
Phototherapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Physical Therapy Modalities, osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of osteoarthritis of the knee (unilateral) according to criteria of the American College of Rheumatology
  • age between 40 and 80 years
  • either gender
  • knee pain and functional disability for at least six months confirmed by historical medical.

Exclusion Criteria:

  • Dementia
  • neurological disorder (sensory or motor)
  • cancer
  • diabetes
  • acute adverse health condition
  • symptoms of osteoarthritis of the hip
  • cardiopulmonary disease that impedes walking
  • need for wheelchair or gait-assistance device
  • and having received steroids through intra-articular injection or orally in the previous six months

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

exercise group

phototherapy group

Phototherapy placebo

Arm Description

An exercise program will be performed to increase range of motion, improve motor learning and strengthen the muscles of the lower limb. The program will include exercises 2 times a week for four weeks. The first week the exercises will be performed with 2 sets of 15 repetitions and the remaining weeks 3 sets of 15 repetitions for each exercise. To exercise will be performed with the resistance of cinnamon, It will be recommended weight by 70% of one repetition maximum painless assigned individually per patient.

And, Phototherapy will be administered with a portable nine-diode cluster. The portable nine-diode cluster will be used overlapping three quadrants of the knee in random sequence: medial quadrant, lateral quadrant and posterior quadrant.with one 905-nm diode (mean power: 1 milliwatt ; peak power: 10 megawatt; spot size: 0.44 cm2), four 875-nm diodes (mean power of each diode: 17.5 milliwatt; spot size: 1 cm2) and four 670-nm diodes (mean power of each diode: 15 mW; spot size: 1 cm2); frequency: 1000 Hz; 300-second irradiation time in each quadrant; total energy: 39.3 Joules per quadrant. Phototherapy will be included in the exercises group.

Phototherapy will be administered with a portable nine-diode cluster. The portable nine-diode cluster will be used overlapping three quadrants of the knee in random sequence: medial quadrant, lateral quadrant and posterior quadrant), with one 905-nm diode (mean power: 0 milliwatt; peak power: 0 watt; spot size: 0.44 cm2), four 875-nm diodes (mean power of each diode: 0 milliwatt; spot size: 1 cm2) and four 670-nm diodes (mean power of each diode: 0 milliwatt; spot size: 1 cm2); frequency: 0 Hz; 300-second irradiation time in each quadrant; total energy: 0 Joules per quadrant. Phototherapy will be included in the exercises group.

Outcomes

Primary Outcome Measures

physical function
Using the Western Ontario and McMaster Universities Arthritis Index

Secondary Outcome Measures

Maximum voluntary isometric contraction
A portable dynamometer will be used to assess muscle contraction.

Full Information

First Posted
March 29, 2014
Last Updated
December 2, 2015
Sponsor
University of Nove de Julho
search

1. Study Identification

Unique Protocol Identification Number
NCT02102347
Brief Title
Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
Official Title
Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program on pain, functional capacity, range of motion, muscle strength in individuals with osteoarthritis of the knees. The participants will be allocated to different groups through a randomization process using opaque envelopes containing cards stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Physical Therapy Modalities, osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Experimental
Arm Description
An exercise program will be performed to increase range of motion, improve motor learning and strengthen the muscles of the lower limb. The program will include exercises 2 times a week for four weeks. The first week the exercises will be performed with 2 sets of 15 repetitions and the remaining weeks 3 sets of 15 repetitions for each exercise. To exercise will be performed with the resistance of cinnamon, It will be recommended weight by 70% of one repetition maximum painless assigned individually per patient.
Arm Title
phototherapy group
Arm Type
Experimental
Arm Description
And, Phototherapy will be administered with a portable nine-diode cluster. The portable nine-diode cluster will be used overlapping three quadrants of the knee in random sequence: medial quadrant, lateral quadrant and posterior quadrant.with one 905-nm diode (mean power: 1 milliwatt ; peak power: 10 megawatt; spot size: 0.44 cm2), four 875-nm diodes (mean power of each diode: 17.5 milliwatt; spot size: 1 cm2) and four 670-nm diodes (mean power of each diode: 15 mW; spot size: 1 cm2); frequency: 1000 Hz; 300-second irradiation time in each quadrant; total energy: 39.3 Joules per quadrant. Phototherapy will be included in the exercises group.
Arm Title
Phototherapy placebo
Arm Type
Placebo Comparator
Arm Description
Phototherapy will be administered with a portable nine-diode cluster. The portable nine-diode cluster will be used overlapping three quadrants of the knee in random sequence: medial quadrant, lateral quadrant and posterior quadrant), with one 905-nm diode (mean power: 0 milliwatt; peak power: 0 watt; spot size: 0.44 cm2), four 875-nm diodes (mean power of each diode: 0 milliwatt; spot size: 1 cm2) and four 670-nm diodes (mean power of each diode: 0 milliwatt; spot size: 1 cm2); frequency: 0 Hz; 300-second irradiation time in each quadrant; total energy: 0 Joules per quadrant. Phototherapy will be included in the exercises group.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Type
Other
Intervention Name(s)
Phototherapy
Primary Outcome Measure Information:
Title
physical function
Description
Using the Western Ontario and McMaster Universities Arthritis Index
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Maximum voluntary isometric contraction
Description
A portable dynamometer will be used to assess muscle contraction.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
lower limb functionality
Description
Using Extremity Functional Scale
Time Frame
9 months
Title
pain
Description
Numeric pain rating scale
Time Frame
9 months
Title
level of pressure pain
Description
threshold digital algometer
Time Frame
9 months
Title
Timed up-and-go test
Description
dynamic equilibrium
Time Frame
9 months
Title
trunk stability
Description
Functional reach test
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of osteoarthritis of the knee (unilateral) according to criteria of the American College of Rheumatology age between 40 and 80 years either gender knee pain and functional disability for at least six months confirmed by historical medical. Exclusion Criteria: Dementia neurological disorder (sensory or motor) cancer diabetes acute adverse health condition symptoms of osteoarthritis of the hip cardiopulmonary disease that impedes walking need for wheelchair or gait-assistance device and having received steroids through intra-articular injection or orally in the previous six months
Facility Information:
Facility Name
University of Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24919587
Citation
Coelho Cde F, Leal-Junior EC, Biasotto-Gonzalez DA, Bley AS, de Carvalho Pde T, Politti F, Gonzalez Tde O, de Oliveira AR, Frigero M, Garcia MB, Dibai-Filho AV, Gomes CA. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:221. doi: 10.1186/1745-6215-15-221.
Results Reference
derived
Links:
URL
http://www.uninove.br
Description
Related Info

Learn more about this trial

Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee

We'll reach out to this number within 24 hrs