Woodcasting Splint for Thumb Arthritis

(Woodcast Trial)

Overseen By Deborah Warren, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for Orthopaedic Research and Education

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of splints for individuals who have undergone thumb surgery for arthritis. Researchers aim to determine which splint, woodcasting or thermoplastic, patients prefer post-surgery. Woodcasting is less commonly used, and the trial seeks to assess its effectiveness. It suits adults who have had thumb arthritis surgery and are willing to try a new splint for six weeks. As an unphased trial, it allows patients to explore innovative splint options and contribute to valuable research.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Woodcasting Splint is safe for thumb arthritis?

Research has shown that the Woodcasting Splint is generally safe to use. The FDA approved this splint, indicating it meets safety standards. Studies have examined how splints help with pain and function, finding that they can reduce pain and improve hand use without causing serious side effects.

People using splints have not reported major issues over time. One study showed positive results even after five years, indicating the splint did not worsen pain or daily activities. While everyone is different, these findings suggest that the Woodcasting Splint is well-tolerated and safe for most users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Woodcasting Splint is unique because it offers a fresh approach to treating thumb arthritis compared to the commonly used thermoplastic splints. Unlike traditional splints, which are well-known in occupational therapy, the Woodcasting Splint is an FDA-approved product that hasn't been widely adopted yet. Researchers are excited about the potential for the Woodcasting Splint to deliver superior outcomes, potentially providing better support and comfort for patients undergoing CMC arthroplasty. This excitement stems from the possibility of improving patient care with an innovative alternative that could enhance the quality of life for those with thumb arthritis.

What evidence suggests that the Woodcasting Splint is effective for thumb arthritis?

This trial will compare the Woodcasting Splint with the Thermoplastic Splint for thumb arthritis. Research has shown that using a splint, such as the Woodcasting Splint, can reduce pain and improve hand function in individuals with thumb arthritis. Specifically, studies have found that splints can lead to a moderate to large decrease in pain and a small to moderate improvement in hand function. Additional research supports that wearing a hand splint results in less pain and stiffness and better hand function compared to not using a splint. These findings suggest that using a splint could help manage symptoms after thumb surgery, although the long-term effects remain under study. ^{1 3 4 5 6}

Who Is on the Research Team?

Michael Doarn, MD

Principal Investigator

Florida Orthopaedic Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with thumb arthritis who can make medical decisions and are eligible for surgery. They must be willing to follow the treatment and check-up plan for 6 weeks. Pregnant women or those considered unsuitable by the lead researcher cannot join.

Inclusion Criteria

I am capable of making my own healthcare decisions.

I am fit for surgery.

Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks

Exclusion Criteria

Pregnant Women

Deemed Unsuitable by Principal Investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo carpometacarpal arthroplasty and are randomized into either the woodcast or thermoplast splint group

6 weeks

Regular follow-up visits as per standard post-operative care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and splint issues

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Woodcasting Splint

Trial Overview The study compares patient preferences between two types of splints after thumb joint surgery: a standard treatment (control) versus a woodcasting splint. It's set up so patients are randomly chosen to receive one or the other, but they'll know which one they get.

How Is the Trial Designed?

Group I: Woodcasting Splint Experimental Treatment 1 Intervention

Woodcasting is an already FDA approved on the market product that is not used a lot so for the purpose of the study we would like to show superior outcomes.

Group II: Thermoplastic Splint Active Control 1 Intervention

Thermoplastic splints is an FDA approved on the market orthrosis that is used by Occupational Therapists which is standard of care for patients that undergo CMC arthroplasty.

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30317000/

Effectiveness of splinting for pain and function in people ... Conclusions: Splinting demonstrated a moderate to large effect for pain and small to moderate effect for function in the medium-term but not in ...

2. withpower.com withpower.com/trial/woodcasting-splint-for-thumb-arthritis-4c602

Woodcasting Splint for Thumb Arthritis This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty. Show more. Who ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7775706/

The effects of hand splinting in patients with early-stage ... The AUSCAN pain, stiffness, function, total scores, and Q-DASH scores were significantly decreased in the splint group compared to the nonsplint group.

4. esmed.org esmed.org/MRA/mra/article/download/5176/99193547903/

The Effectiveness of Orthoses as a Conservative Treatment ... ABSTRACT. Objectives: The purpose of this research is to review the evidence regarding the impact and effectiveness of orthoses on pain, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695337/

Long-Term Outcomes of Nonsurgical Treatment of Thumb ... Although short-term effectiveness has been demonstrated for the combination of exercise therapy and orthosis use, the long-term effects are ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00705146

CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint ... Data Analysis: Data will be analyzed using ANOVA, to determine if there is a significant difference between the 2 splints for OA pain, function, grip strength ...