Low Level Laser Therapy and Interferential Current in Osteoarthritis

• ClinicalTrials.gov Identifier: NCT02898025
• Recruitment Status: Completed
• First Posted: September 13, 2016
• Last Update Posted: October 25, 2017
• Sponsor: Universidade Cidade de Sao Paulo
• Information provided by (Responsible Party): Richard Eloin Liebano, Universidade Cidade de Sao Paulo

Study Description

Brief Summary:

This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Device: Active Interferential Current; Device: Active Laser; Device: Placebo Interferential Current; Device: Placebo Laser	Not Applicable

Detailed Description:

Interventional

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial
• Study Start Date: November 2015
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: G1 (Active IFC and Active Laser); 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G1) will receive the treatment of Active Interferential Current and Active Laser for 12 sessions.	Device: Active Interferential Current; Involves the application of medium frequency alternating currents; Other Names: interferential therapy; IFC; Device: Active Laser; Involves the application of low level laser over the knee; Other Name: low level laser therapy
Active Comparator: G2 (Active IFC and Placebo Laser); 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G2) will receive the treatment of Active Interferential Current and Placebo Laser for 12 sessions.	Device: Active Interferential Current; Involves the application of medium frequency alternating currents; Other Names: interferential therapy; IFC; Device: Placebo Laser; It is a sham laser therapy
Active Comparator: G3 (Placebo IFC and Active Laser); 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G3) will receive Placebo Interferential Current and Active Laser for 12 sessions.	Device: Active Laser; Involves the application of low level laser over the knee; Other Name: low level laser therapy; Device: Placebo Interferential Current; It is a sham interferential therapy
Placebo Comparator: G4 (Placebo IFC and Placebo Laser); 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. The placebo group (G4) will receive Placebo Interferential Current and Placebo Laser for 12 sessions.	Device: Placebo Interferential Current; It is a sham interferential therapy; Device: Placebo Laser; It is a sham laser therapy

Outcome Measures

Primary Outcome Measures :

1. Pain intensity measured by a numeric pain scale ranging from 0 to 10. [ Time Frame: 4 weeks ]
2. Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. TUG (Timed Up & Go Test) [ Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months ]
2. Isokinetic Muscle Assessment [ Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months ]
3. LeQuesne Questionnaire [ Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months ]
4. WOMAC (Western Ontario and McMaster Universities Arthritis Index) [ Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• History of osteoarthritis of the knee characterized by pain of mild or moderate intensity
• Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
• Patients with knee osteoarthritis (s) according to the ACR criteria
• VAS 3 to 8
• 5 to 12 Lequesne
• No complaint of pain in other joints of the lower limbs
• Without neurological and cognitive disorders
• No loss of sensation in the lower limbs
• No surgery on the knee (s) in the last 6 months
• Pain symptoms for at least 6 months
• No infiltrations (s) knee (s) in the last 4 weeks
• No use of analgesics 4 hours before treatment

Exclusion Criteria:

• Individuals younger than 18 and older than 80 years
• Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry

Contacts and Locations

Locations

Brazil

UNICID

Sao Paulo, SP, Brazil, 03071-000

Sponsors and Collaborators

Universidade Cidade de Sao Paulo

Investigators

• Principal Investigator: Richard E Liebano, PhD; Universidade Cidade de Sao Paulo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alqualo-Costa R, Thomé GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.

• Responsible Party: Richard Eloin Liebano, Principal Investigator, Universidade Cidade de Sao Paulo
• ClinicalTrials.gov Identifier: NCT02898025
• Other Study ID Numbers: RLiebano
• First Posted: September 13, 2016
• Last Update Posted: October 25, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases