Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis

Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed with the aim of both interrupting the natural evolution of the disease and alleviating or stopping the symptoms. This study aims to evaluate the effectiveness of personalized Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the quality of life of these patients with the disease.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Osteoarthritis Hand; Osteoarthritis Finger; Osteoarthritis Both Hands
• Intervention / Treatment: Device: Sham Photobiomodulation therapy (Sham PBT); Device: Photobiomodulation therapy (PBT)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05653-070
      • Instituto Vita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical and radiological diagnosis of OA of the fingers of the hand and Rizarthrosis
• Patients with pain for at least 3 months
• Patients undergoing treatment and rehabilitation for finger OA and rhizarthrosis
• Patient with good understanding of the Portuguese language who agrees to participate and sign the ICF

Exclusion Criteria:

• Posttraumatic arthritic changes
• Systemic inflammatory arthritis (Rheumatoid Arthritis, Lupus Erythematosus, Psoriasis…)
• Patients with local or systemic, acute or chronic infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham (group A); Treatment procedure performed with the device that will not provide the bioactive light (laser)	Device: Sham Photobiomodulation therapy (Sham PBT); Similar to active PBT, however, the device will not provide the active electromagnetic waves); Other Names: Sham Laser
Experimental: PBT (group B); Treatment procedure performed with the device that will provide the bioactive light (laser)	Device: Photobiomodulation therapy (PBT); Any invasive procedures will be done. The treatment in question will be done by a device that looks like a bracelet, which is placed on the hand/fingers to emit light/laser and does not cause pain or temperature change. There will be 8 photobiomodulation sessions, 2 per week, 10 minutes each session. The dosimetric parameters of the therapy will be carried out in a standardized and personalized way, with programming of the light and all the necessary information so that the device can carry out the application of the treatment application of electromagnetic waves in the red and infrared spectral range 660-1000 nm).; Other Names: Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Pain at	Visual analogue scale for pain	4 weeks and 2 months
Change from Baseline Arm, Shoulder and Hand Disability	The Disabilities of the Arm, Shoulder and Hand Score	4 weeks and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Hand grip	Hand grip strenght measured by Digital Hand Dynamometer	4 weeks and 2 months
Change from Baseline Pinch force	Pulp to pulp (pinch) force	4 weeks and 2 months
Willingness to recommend the treatment	Net Promoter Score	4 weeks and 2 months
Change from Baseline Hand Disability	Brief Michigan questionnaire	4 weeks and 2 months

Collaborators and Investigators

• Sponsor: Vita Care
• Collaborators: Tegos S.A.
• Investigators: Principal Investigator: Mateus Saito, PhD, Medical Director Instituto Vita

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No