What is the mechanism of action of this treatment?

Common treatments for Carpal Tunnel Syndrome (CTS) include the use of wrist orthoses, manual therapy, and massage therapy. Wrist orthoses, such as the 3D-printed orthosis, provide structural support and stabilization by keeping the wrist in a neutral position, which reduces pressure on the median nerve and alleviates symptoms like pain and numbness. Manual therapy and massage therapy improve wrist function and reduce symptoms by enhancing nerve conduction, wrist strength, and motion. These treatments are crucial for CTS patients as they offer non-invasive options to manage and potentially improve their condition, thereby enhancing their quality of life.

What side effects are associated with this type of intervention?

Common treatments for Carpal Tunnel Syndrome (CTS) that provide structural support and stabilization, such as wrist splints or orthoses, generally have minimal side effects but can include discomfort, skin irritation, and reduced hand function due to immobilization. Corticosteroid injections, another common treatment, may cause temporary pain at the injection site, increased blood sugar levels, and, rarely, nerve damage. Surgical options, such as carpal tunnel release, can lead to complications like infection, nerve injury, and prolonged recovery time.

What prior FDA approvals exist?

FDA-approved treatments for Carpal Tunnel Syndrome (CTS) primarily include wrist splints and braces designed to provide structural support and stabilization by keeping the wrist in a neutral position, thereby reducing pressure on the median nerve. These orthotic devices are often recommended for use during the night to prevent wrist flexion. While there are no specific drugs approved solely for CTS, corticosteroid injections are sometimes used to reduce inflammation and pain. The 3D-Printed Orthosis being studied aims to improve upon these existing treatments by offering a customized fit and potentially enhanced comfort and efficacy.

What other types of research exist?

Promising novel alternatives to 3D-printed orthoses for Carpal Tunnel Syndrome patients in 2024 include: 1) Custom-fitted orthoses using low-temperature thermoplastic materials, which offer personalized support and comfort. 2) Wearable technology with integrated sensors to monitor wrist position and provide real-time feedback to prevent harmful movements. 3) Advanced therapeutic gloves that combine compression and support with therapeutic heat or cold application. 4) Non-invasive neuromodulation devices that use electrical stimulation to alleviate symptoms and improve nerve function.

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Orthosis

3D Printed Wrist Orthosis for Carpal Tunnel Syndrome

N/A

Recruiting

Research Sponsored by TOPMED

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14 of intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new 3D-printed wrist and hand brace designed to help patients with carpal tunnel syndrome and droopy hand. The brace offers custom-fit support without needing external attachments, using a spiral design with a thumb ring.

Who is the study for?

This trial is for adults aged 18-70 with conditions like Carpal Tunnel Syndrome, De Quervain's Tenosynovitis, Drop hand, Ulnar nerve damage, Rhizarthrosis or Tendinopathy of the thumb. Participants must be able to express comfort and discomfort clearly. It excludes those with neuromuscular issues, spasticity, paralysis or insensitivity in the upper limbs.

What is being tested?

The study is testing a new type of wrist and thumb orthosis made using 3D printing technology. The goal is to create an affordable ($150), attachment-free brace that supports healing and rehabilitation for various hand and wrist injuries.

What are the potential side effects?

Potential side effects may include discomfort while wearing the orthosis, skin irritation at contact points or reduced mobility due to improper fit. However, specific side effects will depend on individual experiences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each day during 2 weeks of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each day during 2 weeks of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and each day during 2 weeks of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain during treatment from baseline at day 14

Secondary study objectives

Comfort

Difficulty in donning the orthosis

Functional disability evaluation of the upper member

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Wrist then thumb orthosisExperimental Treatment1 Intervention

Group II: Thumb then wrist orthosisExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Carpal Tunnel Syndrome (CTS) include the use of wrist orthoses, manual therapy, and massage therapy. Wrist orthoses, such as the 3D-printed orthosis, provide structural support and stabilization by keeping the wrist in a neutral position, which reduces pressure on the median nerve and alleviates symptoms like pain and numbness. Manual therapy and massage therapy improve wrist function and reduce symptoms by enhancing nerve conduction, wrist strength, and motion. These treatments are crucial for CTS patients as they offer non-invasive options to manage and potentially improve their condition, thereby enhancing their quality of life.

Use of commercially produced elastic wrist orthoses in chronic arthritis: a controlled study.Characterization and wearability evaluation of a fully portable wrist exoskeleton for unsupervised training after stroke.Rehabilitation following carpal tunnel release.