OMT + Conservative Therapy for Carpal Tunnel Syndrome
(COMET-AOA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kettering Health Network
Disqualifiers: Diabetes, Hypothyroidism, Rheumatoid disorders, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?To evaluate and quantify changes in the elasticity and shear wave modulus (stiffness) of the median nerve in patients diagnosed with mild to moderate carpal tunnel syndrome following osteopathic manipulative therapy.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What data supports the effectiveness of the treatment OMT + Conservative Therapy for Carpal Tunnel Syndrome?
Osteopathic manipulative treatment (OMT) has been shown to be beneficial for managing pain in various conditions, suggesting it might help with carpal tunnel syndrome as well. Although specific studies on carpal tunnel syndrome are not mentioned, the general effectiveness of OMT in pain management supports its potential use in this condition.
12345Is osteopathic manipulative treatment (OMT) generally safe for humans?
Research has shown that osteopathic manipulative treatment (OMT) is generally safe for adults, with studies documenting its safety and efficacy for various conditions.
23678How is Osteopathic Manipulative Treatment (OMT) different from other treatments for Carpal Tunnel Syndrome?
Osteopathic Manipulative Treatment (OMT) is unique because it involves hands-on techniques to improve body function and alleviate pain, focusing on the musculoskeletal system, which is different from standard treatments like medication or surgery. It is a holistic approach that aims to enhance the body's natural healing processes.
23579Eligibility Criteria
This trial is for people with mild to moderate carpal tunnel syndrome, confirmed by recent EMG tests. It's open to those with the condition in one or both hands.Inclusion Criteria
I have been diagnosed with mild to moderate carpal tunnel syndrome.
Exclusion Criteria
My severe carpal tunnel syndrome has led to muscle loss.
I have an underactive thyroid.
I recently had physical therapy for carpal tunnel syndrome.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive osteopathic manipulative therapy and/or conservative treatment for carpal tunnel syndrome
6 weeks
4 visits (in-person) at baseline, 2 weeks, 4 weeks, and 6 weeks
Follow-up
Participants are monitored for changes in nerve elasticity and other outcomes after treatment
2 weeks
1 visit (in-person) at 8 weeks
Participant Groups
The study measures how a type of physical therapy called osteopathic manipulative treatment (OMT) affects the stiffness and elasticity of the median nerve in patients' wrists compared to standard conservative treatments.
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 - OMT OnlyExperimental Treatment1 Intervention
Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
Group II: Group 2 - OMT + Conservative TreatmentActive Control2 Interventions
Will receive Osteopathic manipulative treatment in addition to conservative treatment. Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen. Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
Group III: Group 3 - Conservative Treatment OnlyActive Control1 Intervention
Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen.
Osteopathic Manipulative Treatment (OMT) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Osteopathic Manipulative Treatment for:
- Carpal Tunnel Syndrome
🇪🇺 Approved in European Union as Osteopathic Manipulative Treatment for:
- Carpal Tunnel Syndrome
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kettering HealthDayton, OH
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Who Is Running the Clinical Trial?
Kettering Health NetworkLead Sponsor
American Osteopathic AssociationCollaborator
References
Effects of a structured curriculum in osteopathic manipulative treatment (OMT) on osteopathic structural examinations and use of OMT for hospitalized patients. [2018]Osteopathic manipulative treatment (OMT) is a defining feature of osteopathic medicine; however, use of OMT by osteopathic physicians is declining. Recent studies reveal that many osteopathic physicians are abandoning use of OMT as early as medical school. Current national efforts are aimed at reversing this trend by standardizing osteopathic medical records and clinical training in OMT. The authors found that a structured clinical curriculum in OMT taught to house staff significantly increased the percentage of patients who received osteopathic structural examinations and the percentage of patients who received OMT as part of their hospital care.
Awareness and interest in osteopathic manipulative treatment in allopathic medical students. [2023]Osteopathic manipulative treatment (OMT) is utilized by clinicians to diagnose and treat a variety of musculoskeletal conditions including acute and chronic pain, and other medical conditions. Previous studies have examined attitudes of allopathic (MD) residents toward OMT and have implemented residency-based curricula; however, literature is lacking on the attitudes of MD students toward OMT.
Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. [2022]Osteopathic manipulative treatment (OMT) is a distinctive and foundational aspect of osteopathic medicine. Several studies have reported a decline in the use of OMT by practicing osteopathic physicians, but the reasons for this decline have not been fully investigated.
Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. [2023]Osteopathic manipulative treatment (OMT) has been established as a beneficial and noninvasive treatment option for multiple conditions. With the total number of osteopathic providers tripling and the subsequent increase in osteopathic physician representation, we would expect the clinical use of OMT to increase accordingly.
Osteopathic Manipulative Therapy Potentiates Motor Cortical Plasticity. [2022]Osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) is effective in managing pain caused by a variety of clinical conditions. Nevertheless, the physiologic mechanisms at the basis of the clinical improvement are poorly understood.
Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]Although adverse events in various types of manual therapy have been previously investigated, little is known about the incidence and types of adverse events that occur after osteopathic manipulative treatment (OMT).
Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]To summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions.
Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. [2006]Although studies have been published documenting the safety and efficacy of osteopathic manipulative treatment (OMT) in adults, no studies exist documenting the safety of OMT in pediatric patients.
Immediate effects of osteopathic manipulative treatment in elderly patients with chronic obstructive pulmonary disease. [2022]Osteopathic manipulative treatment (OMT) has long been advocated for patients with respiratory disorders, but little definitive evidence exists to support its use in this population.