Low Level Laser Therapy and exercise to patients with chronic pain and rheumatic diseases: randomized clinical trials with pain , quality of life, functionality assessments and biomechanical aspects.

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4h97rb
• Date of registration: 12/09/2016
• Prospective Registration: Yes
• Primary sponsor: Universidade de Brasília
• Public title: Low Level Laser Therapy and exercise to patients with chronic pain and rheumatic diseases: randomized clinical trials with pain , quality of life, functionality assessments and biomechanical aspects.
• Scientific title: Low Level Laser Therapy and exercise to patients with chronic pain and rheumatic diseases: randomized clinical trials with pain , quality of life, functionality assessments and biomechanical aspects.
• Date of first enrolment: 02/02/2017
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4h97rb
• Study type: Intervention
• Study design: Clinical trial of treatment-controlled randomized, parallel, double-blind, three-arm, phase 2-3.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Renan Fangel
• Affiliation: Universidade de Brasília

• Name: Renan Fangel
• Affiliation: Universidade de Brasília

Key inclusion & exclusion criteria

Inclusion criteria: Being older than 18 years; To track across at least one of the clinics, with diagnosis made by the medical staff; Be able to fill out the consent form and clear.
Exclusion criteria: Having the diagnosis of acute pain; severe psychiatric disorder; Diagnosis of chronic infectious disease; acute or chronic underlying disease with a high probability of death soon; exercise performance or other intensive treatment for pain for up to 48 hours of data collection.

Age minimum: 18Y
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

Osteoarthritis, Arthritis Rheumatoid, Chronic Pain

C05.550.114.154

C10.597.617

C05.550.114.606

Intervention(s)

1nd group - placebo: 30 patients with rheumatoid arthritis and 30 patients with osteoarthritis of the hands are subjected to simulation with low intensity laser therapy.
2nd group - 30 patients with rheumatoid arthritis and 30 patients with osteoarthritis of the hands are subjected to laser therapy with low intensity, with energy 14J applied by hand by finger 2J and 4J by hand.
3rd group - 30 patients with rheumatoid arthritis and 30 patients with osteoarthritis in hands will undergo laser therapy with low intensity energy 28J applied by hand, 4J and 8J by finger by hand.
application points will be used in the distal joints and metacarpophalangeal interfalanges the 2nd to 5th finger and 1 finger in the interphalangeal and metacarpophalangeal joints, totaling 10 points and 10 ventral dorsal. The handle will be used four points, 2 dorsal and 2 ventral, two in the carpometacarpal joint referring to the 3rd finger and two in the radiocarpal joint.

Behavioural

E02.594.540

Radiation

Primary Outcome(s)

Decrease in disease activity parameters, measured by CDAI (Clinical Disease Activity Index), DAS-28 (Disease Activity Score 28) of at least 5% in pre and post-intervention measurements.
Decrease in pain parameter evaluated by VAS- visual analogue scale, BID - brief inventory of pain at least 5% in the pre and post intervention measurements.

Secondary Outcome(s)

Decrease in disease activity parameters, measured by thermography at least 5% in the pre and post-intervention measurements.
Decreased pain parameter algometry evaluated by at least 5% in pre and post-intervention measurements.
Improvement in the parameters of quality of life, assessed by questionnaires: WHOQOL-Bref - (Quality Quick Quiz World Health Organization of Life) and SF-36 (Medical Outcomes Study 36 - Item Short - Form Health Survey) of at least 5 % in the pre and post intervention measurements.
Improvement in parameters of functional capacity and functionality evaluated by tests: HAQ-DI (Health Assessment Questionnaire), DASH (Disabilities of the Arm, Shoulder and Hand) and Jebsen-Taylor test (manual dexterity test) of at least 5% in pre and post intervention measurements.
Improvement in strength parameters through the assessment of grip strength of at least 5% in the pre and post intervention measurements.
Improvement in muscle activation parameters using the electromyography analysis of at least 5% in pre and post-intervention measurements.
Improvement in the kinematic parameters of movement through the movement Qualisys evaluation of at least 5% in the pre and post-intervention measurements.

Source(s) of Monetary Support

Universidade de Brasília

Centro Universitário Unieuro

Secondary Sponsor(s)

Centro Universitário Unieuro