Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:41 AM
Study NCT ID:
NCT07432750
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome
Sponsor:
New York Institute of Technology
Organization:
Study Overview
Official Title:
Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome Using Magnetic Resonance Imaging and Patient Perception
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMM
Brief Summary:
Carpal Tunnel Syndrome (CTS) can be defined as disruption of the median nerve and is characterized by pain, numbness and tingling of the lateral 3.5 digits of the hand. In severe cases, motor function can also be disrupted. There are many factors that can contribute to the development of CTS: inflammation, compression, bony abnormality, mechanical injury, or certain lifestyle choices. Abnormalities have been proven to be tangibly visible with ultrasound in prior research projects in the form of decreased cross sectional area of the carpal tunnel, flattening of the median nerve, retinacular bowing and increased median nerve intensity. Although CTS has proven to be multifactorial, the standard of care for patients with CTS has historically been wrist immobilization and/or surgical release by endoscopic or open approach. This is despite evidence that osteopathic manipulation techniques have been effective in improving quality of life for patients with CTS.
Patients will not be harmed if they are not bracing, as standard of care may include multiple things: bracings vs. OMM vs. surgical release.
Our study will take place over the course of 10 weeks. Patients who have been previously diagnosed with mild or moderate carpal tunnel syndrome by a physician previously will be randomly placed into one of two groups: osteopathic manipulative medicine or bracing. If placed in the bracing category, patients will be given a brace and asked to wear it nightly. If placed in the osteopathic manipulative medicine category, patients will be asked to present to the clinic one time a week for 6 weeks. Each time the patient presents to clinic, they will be treated for 30 minutes.
for 30 minutes of osteopathic manipulative medicine for 6 consecutive weeks.
At the first presentation, patients will obtain a magnetic resonance image of the affected wrist, from which a cross sectional area will be determined. Repeat magnetic resonance image will be obtained at the conclusion of treatment.
Additionally, at the first presentation, 3 weeks into the study, at the end of the study and 4 weeks after the study is completed, each subject will complete the Boston Carpal Tunnel Questionnaire. Descriptive and repeated measures statistical analysis will be performed.
Patients will not be harmed if they are not bracing, as standard of care may include multiple things: bracings vs. OMM vs. surgical release.
Our study will take place over the course of 10 weeks. Patients who have been previously diagnosed with mild or moderate carpal tunnel syndrome by a physician previously will be randomly placed into one of two groups: osteopathic manipulative medicine or bracing. If placed in the bracing category, patients will be given a brace and asked to wear it nightly. If placed in the osteopathic manipulative medicine category, patients will be asked to present to the clinic one time a week for 6 weeks. Each time the patient presents to clinic, they will be treated for 30 minutes.
for 30 minutes of osteopathic manipulative medicine for 6 consecutive weeks.
At the first presentation, patients will obtain a magnetic resonance image of the affected wrist, from which a cross sectional area will be determined. Repeat magnetic resonance image will be obtained at the conclusion of treatment.
Additionally, at the first presentation, 3 weeks into the study, at the end of the study and 4 weeks after the study is completed, each subject will complete the Boston Carpal Tunnel Questionnaire. Descriptive and repeated measures statistical analysis will be performed.
Detailed Description:
Eligibility for participation in the study will be determined by Dr. Jordan Keys and Dr. Priya Bhushan. Additionally, and as, a part of the screening process, all participants will complete the Boston Carpal Tunnel Questionnaire. Patients who rank at least 1 item in each subsection of the Boston Carpal Tunnel Questionnaire with a score 3 or higher will meet the inclusion criteria for our study and will hence continue with consent. Once informed consent is obtained, patients will be randomly assigned to either the osteopathic manipulative medicine or bracing groups. Subjects will choose out of a bag to determine which group they will be in. Papers in the bag will either have the number "1" or "2." Subjects who pick number 1 will be placed in the bracing group. Subjects who pick number 2 will be placed in the osteopathic manipulation group. A magnetic resonance imaging of the affected wrist will also be obtained at the time of consent. Each patient's name and date of birth will be entered into the MRI. At that time, a medical ID number will also be assigned, which will be used to de-identify patients in data storage and collection. Dr. Gabriel Gelves will reassess eligibility for magnetic resonance imaging through the Magnetic Resonance Imaging Screening tool, and he and/or an MRI technician will obtain the MRI. They shall be certified radiologists or physicians with a background in radiology. Volumetric analysis of the visualized Carpal Tunnel will be obtained at several key landmarks using coronal, axial and sagittal views. The scans may take up to 1 hour and will occur in the BRIIC Building. The depth and transverse measurements of the of the Carpal Tunnel along with the morphology of the Median nerve will be analyzed. From that, cross sectional area of the carpal tunnel will be determined and recorded in an encrypted excel sheet. Patients who are placed in the bracing group will be given an Apollo Wrist Brace and informed on how to properly use the brace. They will be asked to wear the brace consistently at night, while sleeping, for 6 weeks. They will be expected to wear the brace for at least 8 hours, to simulate and standardize wearing it while sleeping. These hours will overlap with how long each patient sleeps. The Apollo Wrist Brace will be used because it is constructed of soft and comfortable foam material that allows for maximum hand function. It has universal sizing and is specifically designed to hold the wrist in a neutral position which is optimal for minimizing median nerve compression. The brace provides sufficient immobilization without being too bulky which will increase patient compliance, especially during sleep. It will be considered the standard of care for conservative carpal tunnel treatment. However, it is important to note that patients will not be harmed if they are not bracing, as standard of care may include multiple things: bracings vs. OMM vs. surgical release.
Patients who are assigned to the osteopathic manipulative medicine group will be scheduled to undergo 6 weekly osteopathic manipulative treatment sessions with either Dr. Jordan Keys, Dr. Priya Bhushan or other qualified team member. The protocol for the weekly sessions, developed by osteopathic physicians, will include assessment and treatment of the nervous system (somatic and autonomic), lymphatic drainage and biomechanical structures impacting the function of the upper extremity. The following protocol will be followed- order of treatment dependent upon osteopathic physician treating patient - the order of treatment will depend upon osteopathic physician treating patient Thoracic Outlet Release Thoracic spine treatment (physician will treat somatic dysfunctions (SD) they find with OMT treatment of their choice). This will include assessment of the mid- thoracic region for viscerosomatic changes to the upper extremity). Cervical Spine (physician will treat SD they find with treatment of their choice) Upper extremity treatment will include assessment and treatment of the myofascial structures including the interosseous membrane as well as assessment and treatment of the carpal bones and the flexor retinaculum. Thoracoabdominal Diaphragm release Any additional pertinent SD will be treated as determined by Osteopathic Physician (this will be documented for each patient/each session) Potential treatments will include Counterstrain, Muscle Energy Technique, Facilitated Positional Release, Balanced Ligamentous Tension, High Velocity Low Amplitude, etc.). Treatment will be at the discretion of the performing physician. The treatments administered will be documented through an OMT evaluation form by either Brianna Alexis Nazario M.S. OMS-1 or Georgios Kutrubis OMS-1. After 3 weeks of treatment, all participants will be asked to complete the Boston Carpal Tunnel Syndrome Questionnaire a second time. This will be administered through RedCap. After 6 weeks, treatment will be completed. On the day of their last session, all patients undergoing osteopathic manipulative treatment will undergo a repeat MRI of the wrist, from which the cross sectional area will be obtained again. Patients who were assigned to the bracing group will report to the clinic again after 6 weeks of using the brace. At that time repeat MRI will be obtained. Cross sectional areas will be obtained and recorded.
Patients will also be asked to complete the Boston Carpal Tunnel Syndrome Questionnaire a third time through RedCap. One month after treatment, the patients will complete the Boston Carpal Tunnel Syndrome Questionnaire for the final time. Statistical analysis of the cross sectional area of the carpal tunnel for each subject will be completed using the Wilcoxon signed-rank test. Statistical analysis comparing the efficacies of bracing and osteopathic manipulative treatment will be completed using Mann-Whitney U test. All data will be displayed through several box and whisker plot graphs, as recommended by Dr. Jung. The two control group's scores on the Boston Carpal Tunnel Questionnaire over the course of treatment will be displayed on one graph. Another graph will display the difference in the carpal tunnel cross sectional area throughout treatment, obtained through MRI.
Patients who are assigned to the osteopathic manipulative medicine group will be scheduled to undergo 6 weekly osteopathic manipulative treatment sessions with either Dr. Jordan Keys, Dr. Priya Bhushan or other qualified team member. The protocol for the weekly sessions, developed by osteopathic physicians, will include assessment and treatment of the nervous system (somatic and autonomic), lymphatic drainage and biomechanical structures impacting the function of the upper extremity. The following protocol will be followed- order of treatment dependent upon osteopathic physician treating patient - the order of treatment will depend upon osteopathic physician treating patient Thoracic Outlet Release Thoracic spine treatment (physician will treat somatic dysfunctions (SD) they find with OMT treatment of their choice). This will include assessment of the mid- thoracic region for viscerosomatic changes to the upper extremity). Cervical Spine (physician will treat SD they find with treatment of their choice) Upper extremity treatment will include assessment and treatment of the myofascial structures including the interosseous membrane as well as assessment and treatment of the carpal bones and the flexor retinaculum. Thoracoabdominal Diaphragm release Any additional pertinent SD will be treated as determined by Osteopathic Physician (this will be documented for each patient/each session) Potential treatments will include Counterstrain, Muscle Energy Technique, Facilitated Positional Release, Balanced Ligamentous Tension, High Velocity Low Amplitude, etc.). Treatment will be at the discretion of the performing physician. The treatments administered will be documented through an OMT evaluation form by either Brianna Alexis Nazario M.S. OMS-1 or Georgios Kutrubis OMS-1. After 3 weeks of treatment, all participants will be asked to complete the Boston Carpal Tunnel Syndrome Questionnaire a second time. This will be administered through RedCap. After 6 weeks, treatment will be completed. On the day of their last session, all patients undergoing osteopathic manipulative treatment will undergo a repeat MRI of the wrist, from which the cross sectional area will be obtained again. Patients who were assigned to the bracing group will report to the clinic again after 6 weeks of using the brace. At that time repeat MRI will be obtained. Cross sectional areas will be obtained and recorded.
Patients will also be asked to complete the Boston Carpal Tunnel Syndrome Questionnaire a third time through RedCap. One month after treatment, the patients will complete the Boston Carpal Tunnel Syndrome Questionnaire for the final time. Statistical analysis of the cross sectional area of the carpal tunnel for each subject will be completed using the Wilcoxon signed-rank test. Statistical analysis comparing the efficacies of bracing and osteopathic manipulative treatment will be completed using Mann-Whitney U test. All data will be displayed through several box and whisker plot graphs, as recommended by Dr. Jung. The two control group's scores on the Boston Carpal Tunnel Questionnaire over the course of treatment will be displayed on one graph. Another graph will display the difference in the carpal tunnel cross sectional area throughout treatment, obtained through MRI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: