Trial Outcomes & Findings for Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis. (NCT NCT01738737)

Results Overview

The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

145 participants

Primary outcome timeframe

Baseline and post-intervention, up to 11 weeks

Results posted on

2015-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Stretching Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Placebo Laser + Stretching application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 9 points of application of placebo laser per knee (frontal faces, lateral and medial)	Active Laser + Stretching application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Active Laser Application of active laser only during 24 sessions Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)	Control Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
Overall Study STARTED	29	29	29	29	29
Overall Study COMPLETED	25	25	25	25	25
Overall Study NOT COMPLETED	4	4	4	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stretching n=25 Participants Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Placebo Laser + Stretching n=25 Participants application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)	Active Laser + Stretching n=25 Participants application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Active Laser n=25 Participants Application of active laser only during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)	Control n=25 Participants Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.	Total n=125 Participants Total of all reporting groups
Pain	6.5 cm on Visual Analogue Scale (0-10) STANDARD_DEVIATION 1.4 • n=5 Participants	6.5 cm on Visual Analogue Scale (0-10) STANDARD_DEVIATION 1.7 • n=7 Participants	6.0 cm on Visual Analogue Scale (0-10) STANDARD_DEVIATION 2.2 • n=5 Participants	5.7 cm on Visual Analogue Scale (0-10) STANDARD_DEVIATION 2.1 • n=4 Participants	5.3 cm on Visual Analogue Scale (0-10) STANDARD_DEVIATION 1.9 • n=21 Participants	6.0 cm on Visual Analogue Scale (0-10) STANDARD_DEVIATION 1.9 • n=10 Participants
Self-reported symptoms	35.2 units on scale WOMAC STANDARD_DEVIATION 14.8 • n=5 Participants	33.4 units on scale WOMAC STANDARD_DEVIATION 16.6 • n=7 Participants	32.2 units on scale WOMAC STANDARD_DEVIATION 14.8 • n=5 Participants	39.5 units on scale WOMAC STANDARD_DEVIATION 20.7 • n=4 Participants	33.4 units on scale WOMAC STANDARD_DEVIATION 17.6 • n=21 Participants	34.7 units on scale WOMAC STANDARD_DEVIATION 16.9 • n=10 Participants
Function	10.1 units on Lequesne Functional Question. STANDARD_DEVIATION 4.4 • n=5 Participants	10.1 units on Lequesne Functional Question. STANDARD_DEVIATION 4.7 • n=7 Participants	10.7 units on Lequesne Functional Question. STANDARD_DEVIATION 4.5 • n=5 Participants	11.4 units on Lequesne Functional Question. STANDARD_DEVIATION 5.6 • n=4 Participants	9.3 units on Lequesne Functional Question. STANDARD_DEVIATION 4.5 • n=21 Participants	10.3 units on Lequesne Functional Question. STANDARD_DEVIATION 4.7 • n=10 Participants
Mobility - Timed Get up and Go (TUG)	15.0 seconds STANDARD_DEVIATION 3.0 • n=5 Participants	15.8 seconds STANDARD_DEVIATION 4.0 • n=7 Participants	14.8 seconds STANDARD_DEVIATION 4.0 • n=5 Participants	16.0 seconds STANDARD_DEVIATION 3.0 • n=4 Participants	13.5 seconds STANDARD_DEVIATION 2.4 • n=21 Participants	15.0 seconds STANDARD_DEVIATION 3.3 • n=10 Participants
Knee range of motion	108.0 degrees n=5 Participants	106.0 degrees n=7 Participants	102.0 degrees n=5 Participants	93.0 degrees n=4 Participants	104.0 degrees n=21 Participants	102.6 degrees n=10 Participants
Hamstring shortening	20.0 degrees n=5 Participants	28.0 degrees n=7 Participants	25.0 degrees n=5 Participants	26.0 degrees n=4 Participants	24.0 degrees n=21 Participants	24.6 degrees n=10 Participants
Age, Continuous	61.4 years STANDARD_DEVIATION 8.1 • n=5 Participants	64.8 years STANDARD_DEVIATION 6.3 • n=7 Participants	62.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	66.4 years STANDARD_DEVIATION 5.9 • n=4 Participants	62.4 years STANDARD_DEVIATION 6.3 • n=21 Participants	63.5 years STANDARD_DEVIATION 6.7 • n=10 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	22 Participants n=7 Participants	19 Participants n=5 Participants	18 Participants n=4 Participants	22 Participants n=21 Participants	98 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	27 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and post-intervention, up to 11 weeks

The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.

Outcome measures

Outcome measures
Measure	Active Laser + Stretching n=25 Participants application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Placebo Laser + Stretching n=25 Participants application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)	Stretching n=25 Participants Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Active Laser n=25 Participants Application of active laser only during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)	Control n=25 Participants Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
Change From Baseline in Visual Analogue Scale for Pain	3.2 units on a scale Standard Deviation 2.1	3.8 units on a scale Standard Deviation 2.3	3.1 units on a scale Standard Deviation 2.9	3.3 units on a scale Standard Deviation 2.2	0.7 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline and post-intervention, up to 11 weeks

The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.

Outcome measures

Outcome measures
Measure	Active Laser + Stretching n=25 Participants application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Placebo Laser + Stretching n=25 Participants application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)	Stretching n=25 Participants Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Active Laser n=25 Participants Application of active laser only during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)	Control n=25 Participants Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index	8.0 units on a scale Interval 6.0 to 15.0	11.0 units on a scale Interval 4.5 to 21.5	13.0 units on a scale Interval 5.7 to 22.5	16.0 units on a scale Interval 8.7 to 24.5	2.0 units on a scale Interval -2.5 to 8.5

SECONDARY outcome

Timeframe: Baseline and post-intervention, up to 11 weeks

Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.

Outcome measures

Outcome measures
Measure	Active Laser + Stretching n=25 Participants application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Placebo Laser + Stretching n=25 Participants application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)	Stretching n=25 Participants Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Active Laser n=25 Participants Application of active laser only during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)	Control n=25 Participants Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
Change From Baseline in Range of Motion of Flexion of the Knee	7.0 degress Interval 3.0 to 15.0	10.0 degress Interval 4.0 to 15.2	6.0 degress Interval -1.0 to 11.5	10.0 degress Interval -7.5 to 23.2	1.0 degress Interval -5.5 to 7.0

SECONDARY outcome

Timeframe: Baseline and post-intervention, up to 11 weeks

The scale varies from 0 to 24. Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.

Outcome measures

Outcome measures
Measure	Active Laser + Stretching n=25 Participants application of active laser therapy during nine sessions plus stretching exercises during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial) Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Placebo Laser + Stretching n=25 Participants application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)	Stretching n=25 Participants Seven stretching exercises for lower limbs during 24 sessions Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions	Active Laser n=25 Participants Application of active laser only during 24 sessions Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)	Control n=25 Participants Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
Change From Baseline in Lequesne Functional Questionnaire	2.5 units on a scale Interval 0.4 to 5.1	1.5 units on a scale Interval 0.5 to 5.2	4.0 units on a scale Interval 0.5 to 6.6	3.5 units on a scale Interval 1.9 to 5.6	0.0 units on a scale Interval -2.2 to 1.0

SECONDARY outcome

Timeframe: Baseline and post-intervention, up to 11 weeks

Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.