Low Level Laser Therapy and Interferential Current in Osteoarthritis

NCT02898025 | Completed

• 1 other identifier: RLiebano
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Pain intensity measured by a numeric pain scale ranging from 0 to 10.

  4 weeks

• Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.

  4 weeks

Secondary Outcomes (4)

• TUG (Timed Up & Go Test)

  Measure at baseline, 4 weeks, 3 months, 6 months

• Isokinetic Muscle Assessment

  Measure at baseline, 4 weeks, 3 months, 6 months

• LeQuesne Questionnaire

  Measure at baseline, 4 weeks, 3 months, 6 months

• WOMAC (Western Ontario and McMaster Universities Arthritis Index)

  Measure at baseline, 4 weeks, 3 months, 6 months

Study Arms (4)

G1 (Active IFC and Active Laser)

ACTIVE COMPARATOR

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; Device: Active Laser

G2 (Active IFC and Placebo Laser)

ACTIVE COMPARATOR

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; Device: Placebo Laser

G3 (Placebo IFC and Active Laser)

ACTIVE COMPARATOR

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; Device: Placebo Interferential Current

G4 (Placebo IFC and Placebo Laser)

PLACEBO COMPARATOR

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; Device: Placebo Laser

Interventions

Active Interferential Current DEVICE

Involves the application of medium frequency alternating currents

Also known as: interferential therapy, IFC

G1 (Active IFC and Active Laser); G2 (Active IFC and Placebo Laser)

Active Laser DEVICE

Involves the application of low level laser over the knee

Also known as: low level laser therapy

G1 (Active IFC and Active Laser); G3 (Placebo IFC and Active Laser)

Placebo Interferential Current DEVICE

It is a sham interferential therapy

G3 (Placebo IFC and Active Laser); G4 (Placebo IFC and Placebo Laser)

Placebo Laser DEVICE

It is a sham laser therapy

G2 (Active IFC and Placebo Laser); G4 (Placebo IFC and Placebo Laser)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

UNICID

São Paulo, São Paulo, 03071-000, Brazil

Location

Related Publications (1)

• Alqualo-Costa R, Thome 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.

  PMID: 29722602 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Electric Stimulation Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Laser Therapy; Phototherapy

Study Officials

• Richard E Liebano, PhD

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: September 13, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

BR (1)