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

Trial Summary

What is the purpose of this trial?

This research proposes to evaluate the effectiveness of a novel device designed for the treatment of carpal tunnel syndrome. The device applies a small cyclic force to the wrist. The cycles include a small time period of force is applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep. The efficacy of the treatment is evaluated based on patient reported outcomes. Treatment efficacy will also be evaluated based on comparisons to patient reported outcomes for a SOC treatment.

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 data supports the effectiveness of the treatment Carpal Arch Space Augmentation (CASA) for Carpal Tunnel Syndrome?

The research on mechanical wrist traction, a non-invasive treatment for Carpal Tunnel Syndrome, shows it can reduce symptom severity compared to standard care, suggesting that non-surgical treatments like CASA might also be effective in managing symptoms. ^{1 2 3 4 5}

How is the CASA treatment for Carpal Tunnel Syndrome different from other treatments?

The CASA treatment for Carpal Tunnel Syndrome is unique because it focuses on augmenting the carpal arch space, which may help relieve pressure on the median nerve, unlike traditional treatments that often involve surgery or splinting to reduce symptoms. ^{6 7 8 9 10}

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

I have a chronic condition like diabetes or thyroid disease.

Body mass index greater than 35

I have had surgery for carpal tunnel syndrome on my right hand.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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). [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up Results of Mechanical Wrist Traction as Non-Invasive Treatment for Carpal Tunnel Syndrome. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Carpal tunnel syndrome caused by space occupying lesions. [2021]

4. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome: a randomized controlled study. [2009]

5. United States 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. [2013]

6. France pubmed.ncbi.nlm.nih.gov

Alveolar bone changes after tooth-borne surgically assisted rapid maxillary expansion: A three-dimensional study. [2023]

7. Denmark 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. India pubmed.ncbi.nlm.nih.gov

Sleeve Push Technique: A Novel Method of Space Gaining. [2020]

10. Denmark 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. [2022]