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

NCT05041231 | Completed

• 1 other identifier: 133
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Osteoarthritis Finger; Osteoarthritis Hand; Osteoarthritis Both Hands

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change from Baseline Hand grip

  4 weeks and 2 months

• Change from Baseline Pinch force

  4 weeks and 2 months

• Willingness to recommend the treatment

  4 weeks and 2 months

• Change from Baseline Hand Disability

  4 weeks and 2 months

Study Arms (2)

Sham (group A)

SHAM COMPARATOR

Treatment procedure performed with the device that will not provide the bioactive light (laser)

Device: Sham Photobiomodulation therapy (Sham PBT)

PBT (group B)

EXPERIMENTAL

Treatment procedure performed with the device that will provide the bioactive light (laser)

Device: Photobiomodulation therapy (PBT)

Interventions

Photobiomodulation therapy (PBT) DEVICE

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).

Also known as: Laser

PBT (group B)

Sham Photobiomodulation therapy (Sham PBT) DEVICE

Similar to active PBT, however, the device will not provide the active electromagnetic waves)

Also known as: Sham Laser

Sham (group A)

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vita Care: lead
• Tegos S.A.: collaborator

Study Sites (1)

Instituto Vita

São Paulo, São Paulo, 05653-070, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Low-Level Light Therapy; Lasers

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Mateus Saito, PhD

  Medical Director Instituto Vita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 10, 2021
• Study Start: August 25, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 20, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)