CASA Device for Carpal Tunnel Syndrome

(CASA Trial)

Overseen By Zong-Ming Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Pain medication

Disqualifiers: Diabetes, Thyroid disease, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 9

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to help people with carpal tunnel syndrome, a condition causing pain and numbness in the hand. The device, called Carpal Arch Space Augmentation (CASA), gently presses on the wrist in cycles during sleep. Researchers aim to determine if this device is more effective than the standard wrist brace. Individuals diagnosed with carpal tunnel syndrome in their right hand who haven't recently used other treatments might be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for carpal tunnel syndrome.

Will I have to stop taking my current medications?

The trial requires that you have not taken pain medication within 2 weeks before starting the study and that you do not participate in other carpal tunnel syndrome treatments during the study.

What prior data suggests that this device is safe for treating carpal tunnel syndrome?

Research shows that the CASA device is designed to help with carpal tunnel syndrome by gently increasing the space in the wrist where the nerve passes through. In one study, 181 patients used a similar treatment that gently stretched the wrist, and only 37% of them needed surgery later. This suggests that the treatment could be effective for many people.

While detailed safety information for the CASA device is not yet available, it is non-surgical and intended for use during sleep, which suggests it might be easy to tolerate. As the trial progresses, more safety information will become available as more people use the device. It is always advisable to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Carpal Arch Space Augmentation (CASA) for carpal tunnel syndrome because it offers a novel approach to treatment. Unlike the standard care, which typically involves braces or surgical options, CASA uses a device to increase the space within the carpal tunnel. This unique mechanism could relieve pressure on the median nerve without the need for invasive surgery. By potentially offering relief with less downtime and fewer complications, CASA might significantly improve patient outcomes.

What evidence suggests that this device is effective for carpal tunnel syndrome?

Research has shown that Carpal Arch Space Augmentation (CASA), which participants in this trial may receive, may help treat carpal tunnel syndrome by creating more space in the wrist area. Studies have found that this can lead to better movement of the median nerve, less nerve delay, and improved nerve size. These changes can help ease symptoms like pain and numbness. One study using a mechanical traction method found that fewer patients needed surgery, reducing the rate to 37%. These early findings suggest that CASA could lower the need for more invasive treatments. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with right-handed or bilateral Carpal Tunnel Syndrome (CTS). It's focused on treating the right hand only, even if both hands are affected. Participants should have a confirmed diagnosis of CTS to join.

Inclusion Criteria

I have carpal tunnel syndrome in my right hand or both hands.

Exclusion Criteria

I am currently pregnant.

I have a chronic condition like diabetes or thyroid disease.

Body mass index greater than 35

Timeline for a Trial Participant

Run-in

Subjects are randomized and undergo compliance testing, along with a brief duration of device wearing, to ensure they conform with protocol instructions

2 weeks

1 visit (in-person)

Intervention

Participants wear their assigned device/brace nightly and report adherence daily. Weekly phone calls are conducted to report outcome measures

4 weeks

4 visits (virtual)

Follow-up

Participants continue to receive weekly phone calls to monitor safety and effectiveness after the intervention

4 weeks

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Carpal Arch Space Augmentation (CASA)

Trial Overview The study is testing a new device called CASA against the standard care for CTS. The device applies cyclic force to the wrist during sleep and its effectiveness is measured by what patients report about their symptoms compared to those receiving usual treatment.

How Is the Trial Designed?

Group I: CASA Arm Experimental Treatment 1 Intervention

Arm that will be given the test intervention device.

Group II: SOC Arm Active Control 1 Intervention

Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 181 patients with carpal tunnel syndrome, mechanical traction treatment resulted in a lower percentage of patients requiring surgery (37%) compared to those receiving usual care (44%), although this difference was not statistically significant.

Patients who received mechanical traction reported a greater reduction in symptom severity over 12 months compared to those in the usual care group, suggesting that mechanical traction may be a beneficial non-invasive treatment option for those preferring conservative management of CTS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up Results of Mechanical Wrist Traction as Non-Invasive Treatment for Carpal Tunnel Syndrome. Meems, M., Boekhorst, MGBM., Pop, VJM.[2021]

A study of 39 patients undergoing surgically assisted rapid maxillary expansion (SARME) revealed significant vestibular bone loss, particularly around the first upper molars, with bone thickness decreasing from 0.93 mm to 0.53 mm and bone height from 1.84 mm to 0.93 mm (p < 0.0001).

The procedure also resulted in notable root resorption in the first upper molar, with reductions of up to 0.55 mm in various root areas, while achieving an average maxillary expansion of 3.76 mm at the premolar level and 1.41 mm at the molar level (p < 0.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alveolar bone changes after tooth-borne surgically assisted rapid maxillary expansion: A three-dimensional study. Martin, A., Oyallon, M., Perrin, JP., et al.[2023]

In a study involving six Macaca fascicularis, the use of a socket cap and anorganic bovine bone mineral (ABBM) significantly reduced bone width loss after tooth extraction, with only 4% loss compared to 52% in untreated controls within 6 weeks.

The combination of a socket cap, socket cage, and ABBM was particularly effective in maintaining both width and height of the alveolar bone in sockets with facial dehiscence, suggesting these devices can enhance healing post-extraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alveolar ridge dimensional changes following ridge preservation procedure with novel devices: Part 1--CBCT linear analysis in non-human primate model. Min, S., Liu, Y., Tang, J., et al.[2021]

Wearing a wrist support splint for 8 weeks, combined with a formal education program, significantly improved symptom severity and functional status in patients with carpal tunnel syndrome (CTS) compared to a control group.

Factors such as higher symptom severity, functional deficits, and pain scores were associated with a greater desire for surgical intervention among patients, indicating that conservative treatment can effectively reduce the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the effectiveness of full-time wrist splinting and education in the treatment of carpal tunnel syndrome: a randomized controlled trial. Hall, B., Lee, HC., Fitzgerald, H., et al.[2013]

The new surgical device, Extension Crest, demonstrated a high success rate of 97.8% in widening narrow edentulous alveolar ridges, allowing for the successful placement of 110 titanium implants in patients with horizontal ridge resorption.

The cumulative success and survival rates of the implants were 95.4% and 97.3%, respectively, indicating that this technique is reliable and may reduce recovery time and complications compared to traditional methods like autogenous bone grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental implants placed in expanded narrow edentulous ridges with the Extension Crest device. A 1-3-year multicenter follow-up study. Chiapasco, M., Ferrini, F., Casentini, P., et al.[2022]

The sleeve push technique (SPT) allows for space gaining and alignment in orthodontics from the very first day of treatment, using a combination of nickel-titanium wires and protective archwire sleeves.

This new method overcomes the limitation of traditional nickel-titanium coil springs, which require well-aligned arches before use, providing a more effective and immediate solution for orthodontic space management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeve Push Technique: A Novel Method of Space Gaining. Verma, S., Bhupali, NR., Gupta, DK., et al.[2020]

In a study of 11 patients with carpal tunnel syndrome (CTS) caused by space-occupying lesions (SOL), surgery led to complete symptom relief without complications, indicating the efficacy of surgical intervention for this condition.

The research highlights the importance of using imaging techniques like MRI and CT to identify SOLs in patients with wrist swelling or tenderness, ensuring accurate diagnosis and appropriate treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carpal tunnel syndrome caused by space occupying lesions. Kang, HJ., Jung, SH., Yoon, HK., et al.[2021]

In a study of 120 patients with carpal tunnel syndrome, both a soft hand brace and a wrist splint showed significant improvements in symptoms and function after 3 months of use, as measured by the Boston Carpal Tunnel Questionnaire.

While both treatments provided initial relief, the wrist splint (CAMP TIELLE) continued to show a significant reduction in pain after 9 months, although no significant functional benefits were observed in either group at that time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome: a randomized controlled study. De Angelis, MV., Pierfelice, F., Di Giovanni, P., et al.[2009]

A new design modification for dental appliances enables complete distal movement of the upper arch, which could enhance treatment outcomes in orthodontics.

A case report demonstrates the practical application of this design, showcasing its effectiveness in achieving desired dental adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A variation in removable appliance design for distal movement or anchorage reinforcement. Barnett, DP.[2019]

This randomized double-blind placebo-controlled trial will evaluate the efficacy of two doses of Methylprednisolone injections in relieving symptoms of idiopathic carpal tunnel syndrome (CTS) in 120 patients who have not previously received steroid treatment.

The primary outcomes will assess changes in CTS symptom severity at 10 weeks and the rate of surgery needed at 52 weeks, providing important insights into the long-term effectiveness of steroid injections for CTS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: protocol of a randomized double-blind placebo-controlled trial (NCT 00806871). Flondell, M., Hofer, M., Björk, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06208709

Carpal Arch Space Augmentation (CASA) Clinical Trial This clinical trial seeks to determine the effectiveness of the CASA device in alleviating CTS pain by augmenting the carpal arch space. During an early ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10259465/

Non-Surgical Carpal Arch Space Augmentation for Median ... This paper is to review several approaches we have developed for nonsurgical carpal arch space augmentation (CASA), namely, radio ulnar wrist compression.

3. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/carpal-tunnel-syndrome-intervention-improves-symptoms-in-two-weeks

Carpal Tunnel Syndrome Intervention Improves Symptoms Patients showed significantly increased median nerve mobility, decreased distal motor latency and improved median nerve cross-sectional area ...

4. withpower.com withpower.com/trial/phase-carpal-tunnel-syndrome-3-2024-3fe8f

CASA Device for Carpal Tunnel Syndrome (CASA Trial) In a study of 181 patients with carpal tunnel syndrome, mechanical traction treatment resulted in a lower percentage of patients requiring surgery (37%) ...

5. sciencedirect.com sciencedirect.com/science/article/am/pii/S0268003323000190

Carpal Arch Space Increased by Volar Force Applied to the ... Carpal arch space augmentation can be achieved not only by carpal ... effectiveness of manipulating the carpal tunnel mechanics in treating carpal tunnel syndrome ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/condition/250/carpal-tunnel-syndrome?page=3

Carpal Tunnel Syndrome Clinical Research Trials ... carpal tunnel. This clinical trial seeks to determine the effectiveness of the CASA device in alleviating CTS pain by augmenting the carpal arch space.

7. studies.medicine.arizona.edu studies.medicine.arizona.edu/trials/casa-pilot-clinical-trial

CASA Pilot Clinical Trial This research proposes to evaluate the effectiveness of a novel device designed for the non-surgical treatment of carpal tunnel syndrome.