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

Not Applicable

Completed

• Conditions: Osteoarthritis Hand; Osteoarthritis Both Hands; Osteoarthritis Finger; Osteoarthritis
• Interventions: Device: Photobiomodulation therapy (PBT); Device: Sham Photobiomodulation therapy (Sham PBT)

• Registration Number: NCT05041231
• Lead Sponsor: Vita Care

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-10
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-01-20
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBT (group B)	Photobiomodulation therapy (PBT)	Treatment procedure performed with the device that will provide the bioactive light (laser)
Sham (group A)	Sham Photobiomodulation therapy (Sham PBT)	Treatment procedure performed with the device that will not provide the bioactive light (laser)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Vita; 🇧🇷 São Paulo, SP, Brazil