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Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.
ABSTRACT Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services. Participants: Eighty participants with knee osteoarthritis were randomized. Intervention: Participants were randomized into four groups: Group I (n=20; LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation), Group II (n=20; Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation), Group III (n=20; LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation), Group IV (n=20; Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation). The groups treated with LLLT received treatments with invisible infrared laser (904 nm, 3 Joules/point). The Placebo groups received identical treatment, but the infrared laser output was disabled. The sessions occurred three times a week.
Main outcome measures: The primary outcome was the change in knee pain and functionality (Lequesne). Secondary outcomes included change in mobility (8 meters and Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire) and medication intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation |
|
| Group II | Placebo Comparator | Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation |
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| Group III | Active Comparator | LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation |
|
| Group IV | Placebo Comparator | Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low level Laser Therapy and Russian electrical stimulation | Other | LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | numeric pain rating scale (0-10) with a minimal clinically important change of two points | 6 months from baseline (follow up) |
| Functionality | Was measured using the Lequesne questionnaire (11 questions about pain, discomfort and function). Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction). | 6 months from baseline (follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Medication intake | Paracetamol | 6 months from baseline (follow up) |
| Mobility and balance | were evaluated by the Timed Up and Go (TUG) test19 and the 8-meter walk test.20 The TUG test, a measure of functional mobility, quantifies in seconds the time that the individual needs to stand up from a chair, walk 3m, turn back toward the chair and sit down again. The 8-meter walk test measures the time and number of steps required for a person to walk 8m. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia P Alfredo, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo | São Paulo | 05360-160 | Brazil |
The results obtained with the study will be made available to participants at the end of the study. These data will be published in articles, so that the anonymity of the participants is guaranteed.
All subjects who agreed to participate in the study signed a free and informed consent form and authorized the dissemination of the study results in articles or abstracts presented at scientific congresses.
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| Placebo Laser and Russian electrical stimulation | Other | Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation |
|
| Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation | Other | LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation |
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| Placebo Laser and Placebo Laser plus Russian electrical stimulation | Other | Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation |
|
| 6 months from baseline (follow up) |
| Range of motion of the knees | was measured with a universal goniometer (AESCULAP). | 6 months from baseline (follow up) |
| Muscular strength | was estimated at maximal isometric force for the quadriceps, using a portable dynamometer (Lafayette, USA). Under stabilized conditions, patients, sitting with knees flexed at 60 (measured by a goniometer),21 were asked to extend the legs as far as they could. Three trials were conducted, and the mean value was obtained. | 6 months from baseline (follow up) |
| Activity | was measured using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire,22 which is self-administered and measures pain, frozen joints and physical activity. Increased scores suggest decreased activity. | 6 months from baseline (follow up) |
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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