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

NCT ID: NCT05041231

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2023-01-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham (group A)

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

Group Type: SHAM_COMPARATOR

Sham Photobiomodulation therapy (Sham PBT)

Intervention Type: DEVICE

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

PBT (group B)

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

Group Type: EXPERIMENTAL

Photobiomodulation therapy (PBT)

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Sham Photobiomodulation therapy (Sham PBT)

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

Intervention Type: DEVICE

Other Intervention Names

Laser; Sham Laser

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tegos S.A.

UNKNOWN

Sponsor Role: collaborator

Vita Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mateus Saito, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Director Instituto Vita

Locations

Instituto Vita

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

133

Identifier Type: -

Identifier Source: org_study_id