NCT07171840

Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis

Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Humanitas Clinical and Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis of trapezio-metacarpal joint (TMJ) most commonly occurs in women over 50 years old, often bilateral and it is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and impairment of hand function with limitation in gripping and pinching objects. There are several surgical treatment options for TMJO as well as many conservative treatments such as splinting, thumb strengthening exercises, anti-inflammatory drugs and intra-articular injections. There are no currently approved TMJO treatments capable of slowing OA-related structural progression, so the main goals of the conservative treatment are to provide symptomatic relief, improve joint function, and delay surgical intervention. In recent years, the interest in the use of ozone is in constant increase especially because of the biological properties of inducing analgesia, anti-inflammatory, and antioxidant effects. Some articles have reported promising results on the effectiveness of oxygen-ozone, but the evidence is low. So, the aim of this study is to evaluate the effectiveness of intra-articular oxygen-ozone therapy (OOT) combined with thumb splint and compare it with only the splint therapy.

Detailed description

Osteoarthritis is a degenerative condition that causes pain, impaired function and affects daily activities. In osteoarthritis, there is the destruction of cartilage and subchondral bone, with the consequent narrowing of articular space. Several factors have been associated with the development of degenerative changes in the carpometacarpal joint (CMCJ), including increased thumb base joint laxity and greater grip strength. Trapezio-metacarpal joint (TMJ) is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and limitation of hand function. The patient with symptomatic TMJO in its initial stages is usually treated conservatively before surgical intervention: one of the main actions of intra-articular treatments, ranging from corticosteroids to hyaluronic acid and biologic products is to reduce inflammatory distress within the joint; injection treatments are usually used alone or in combination with thumb splint in a multimodal rehabilitation approach. In recent years, there has been a growing interest in the effects of ozone because intra-articular administration of an adequate mixture of oxygen-ozone is supposed to reduce pain, to have protective immunomodulatory effects on cartilage, and to reduce oxidative stress, thus potentially representing an alternative to other injective methods. However, is still unclear what best therapeutic protocol is in terms of ozone concentration, volume to be injected, number of injections and time between injections. This study will compare the efficacy of OOT injection plus thumb splint to only joint splint in patients with painful unilateral thumb OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment (e.g. physical therapy, simple analgesics). This will be done using a randomized controlled trial with study subjects receiving a cycle of two injection of OOT plus thumb splint. The primary study objective is to determine whether two injections of OO and thumb splint are superior to the use of only the joint splinting in reducing pain and this is measured by the improvement in DASH score from baseline. Secondary objectives of this study are improvement in VAS Pain, Grip Strength Function and Tip Pinch Function. During screening, potential subjects who provide informed consent will be assessed for eligibility. Screening will consist in checking the presence of inclusion and exclusion criteria, including symptomatic OA in one thumb joint from 3 months and a thumb joint radiograph showing an Eaton and Litter grade of 1 to 3 and an absence of severe osteoarthritis. Subjects will also provide demographic and medication use information. Baseline X-ray will be collected.

Conditions

• Thumb Osteoarthritis

Interventions

Type	Name	Description
DRUG	10 cc of oxygen-ozone plus thumb splint	Oxygene-Ozone therapy plus splint therapy
DEVICE	thumb splint	thermoplastic splint

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-07-23
• Completion: 2022-12-23
• First posted: 2025-09-15
• Last updated: 2025-09-26

Locations

1 site across 1 country: Italy