CASA Device for Carpal Tunnel Syndrome
(CASA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arizona
Must not be taking: Pain medication
Disqualifiers: Diabetes, Thyroid disease, Rheumatoid arthritis, others
No Placebo Group
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.
12345How 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.
678910Eligibility 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.
+9 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CASA ArmExperimental Treatment1 Intervention
Arm that will be given the test intervention device.
Group II: SOC ArmActive Control1 Intervention
Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ArizonaTucson, AZ
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Who Is Running the Clinical Trial?
University of ArizonaLead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
References
Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: protocol of a randomized double-blind placebo-controlled trial (NCT 00806871). [2021]Patients with idiopathic carpal tunnel syndrome (CTS) are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection.
Long-Term Follow-Up Results of Mechanical Wrist Traction as Non-Invasive Treatment for Carpal Tunnel Syndrome. [2021]> Background: For patients with carpal tunnel syndrome (CTS), the only long-term effective treatment option is carpal tunnel release surgery. Up to one-third report recurrent symptoms, and 12% needs repeated surgery. This study aimed to evaluate the long-term effects of mechanical traction as a non-invasive treatment option for CTS compared to care as usual. Methods: Patients with electrodiagnostically confirmed CTS [N = 181; mean age, 58.1 (13.0) years; 67% women] were recruited from an outpatient neurology clinic in the Netherlands. Patients completed baseline questionnaires and randomized to the intervention group (12 treatments with mechanical traction, twice a week for 6 weeks) or care as usual. The primary clinical outcome measure was surgery during the 12-month follow-up. Secondly, we assessed symptom severity with the Boston Carpal Tunnel Questionnaire (BCTQ) at baseline and at the 12-month follow-up. Changes in CTS symptom severity between baseline and the 12-month follow-up were analyzed between groups using t-tests and a multiple linear regression analyses, adjusting for duration of complaints, age, gender, and symptom severity at baseline. Results: At the 12-month follow-up, 35 of 94 (37%) patients in the intervention group had surgery, compared to 38 of 87 (44%) in the care-as-usual group ( χ 1 2 = 0.78, p = 0.377). Symptom severity and functional status scores did not significantly differ between the intervention (n = 81) and care-as-usual group (n = 55) at follow-up. For patients who did not have surgery, BCTQ scores decreased significantly more from baseline to the 12-month follow-up in the intervention group (n = 53) compared to patients in the care-as-usual group (n = 25). For patients who did not have surgery, belonging to the intervention group and a higher BCTQ score at baseline were related to a greater decrease in BCTQ scores from baseline to the 12-month follow-up, as well as symptom severity and functional status. Conclusions: Mechanical traction is effective in reducing symptom severity compared to current conservative treatment options in standard care and can therefore benefit the large number of patients that prefer conservative treatment for CTS. Clinical Trial Registration: Clinical Trials NL44692.008.13. Registered 19 September 2013, https://clinicaltrials.gov/ct2/show/NCT01949493.
Carpal tunnel syndrome caused by space occupying lesions. [2021]To evaluate the diagnosis and treatment of the carpal tunnel syndrome (CTS) due to space occupying lesions (SOL).
Efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome: a randomized controlled study. [2009]To examine, in a randomized, controlled, single blinded trial, the efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome (CTS).
Investigating the effectiveness of full-time wrist splinting and education in the treatment of carpal tunnel syndrome: a randomized controlled trial. [2013]This study investigated the effects of wearing a wrist support splint for 8 wk and receiving a formal education program on patients with carpal tunnel syndrome (CTS), as well as factors associated with patients' desire to seek surgical intervention. Participants were recruited from a hospital surgical wait list and randomly assigned to an intervention group (n = 30) or a control group (n = 24). Significant improvements in measures of symptom severity and functional status over the duration of the study appeared in the intervention group but not in the control group. Logistic regression for the intervention group showed that symptom severity (odds ratio [OR] = 1.53, 95% confidence interval [CI] [1.20-1.93]), functional deficits (OR = 1.31, 95% CI [1.08-1.57]), pain score (OR = 1.25, 95% CI [1.11-1.61]), and symptom duration (OR = 1.11, 95% CI [1.01-1.24]) were positively associated with the desire to seek surgical intervention. This conservative CTS treatment program conducted by occupational therapists can improve symptoms and hand function in CTS patients.
Alveolar bone changes after tooth-borne surgically assisted rapid maxillary expansion: A three-dimensional study. [2023]Surgically assisted rapid maxillary expansion (SARME) with a dental-anchorage appliance can induce dental and skeletal complications adjacent to the teeth supporting the device. The purpose of this study was to quantify the dentoskeletal changes observed after SARME using a tooth-borne device.
Alveolar ridge dimensional changes following ridge preservation procedure with novel devices: Part 1--CBCT linear analysis in non-human primate model. [2021]This study sought to investigate dimensional changes to the alveolar bone following extraction and application of novel devices used for obturation of socket orifice (socket cap) and space maintenance in sockets with facial dehiscence (socket cage).
A variation in removable appliance design for distal movement or anchorage reinforcement. [2019]A modification to appliance design is described to allow total distal movement of the upper arch and a case report presented to illustrate its use.
Sleeve Push Technique: A Novel Method of Space Gaining. [2020]Space gaining is frequently required in orthodontics. Multiple loops were initially used for space gaining and alignment. The most common used mechanics for space gaining is the use of nickel-titanium open coil springs. The disadvantage of nickel-titanium coil spring is that they cannot be used until the arches are well aligned to receive the stiffer stainless steel wires. Therefore, a new method of gaining space during initial alignment and leveling has been developed and named as sleeve push technique (SPT). The nickel-titanium wires, i.e. 0.012 inches and 0.014 inches along with archwire sleeve (protective tubing) can be used in a modified way to gain space along with alignment. This method helps in gaining space right from day 1 of treatment. The archwire sleeve and nickel-titanium wire in this new SPT act as a mutually synergistic combination and provide the orthodontist with a completely new technique for space opening.
Dental implants placed in expanded narrow edentulous ridges with the Extension Crest device. A 1-3-year multicenter follow-up study. [2022]This study has been designed to evaluate the capability of a new surgical device (Extension Crest) to widen narrow edentulous alveolar ridges and to allow a correct placement of endosseous implants in horizontally atrophied sites.