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| Name | Class |
|---|---|
| American Osteopathic Association | OTHER |
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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.
This small pilot study aimed to investigate whether the imaging modality known as shear wave elastography (SWE) could be used to objectively quantify post treatment changes in the soft tissues of the carpal tunnel as a result of Osteopathic Manipulative Therapy (OMT) in patients with mild to moderate-severe carpal tunnel syndrome (CTS). Patients were randomly assigned into three treatment groups for six weeks: OMT only, traditional conservative care (ie. splits and steroid injections), or a combination of both OMT and conservative therapy.
The primary outcome was to evaluate the stiffness of the median nerve, the transverse carpal ligament and the intra-carpal tunnel contents. Our team also used traditional grayscale ultrasound to measure the cross-sectional diameter of the nerve as well as the standard, often uncomfortable, electromyography (EMG) test to assess pre- and post-treatment nerve function. Patient outcomes were tracked using both patient surveys which captured a participant's symptoms and level of function as well as clinician assessment tools. Osteopathic Manipulative Treatment (OMT) was a treatment technique used involving a hands-on exam to diagnose, prevent, and treat various musculoskeletal conditions by addressing structural imbalance in the body's bones and soft tissues. Those subjects in the conservative therapy only group were treated with splint and steroid injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - OMT Only | Experimental | 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. |
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| Group 2 - OMT + Conservative Treatment | Active Comparator | 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. |
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| Group 3 - Conservative Treatment Only | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic manipulative treatment (OMT) | Other | Two osteopathic primary care physicians will performing osteopathic manipulative techniques with a minimum of three direct techniques focused on carpal tunnel. These techniques will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. They will also evaluate and treat the cervical spine, with particular attention to the C5-7 levels, all the way to the wrist and hand as they see fit based on the findings of their osteopathic structural exam. |
| Measure | Description | Time Frame |
|---|---|---|
| Elasticity of median nerve at the carpal tunnel inlet | Measured by shear wave elastography. | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment |
| Cross-sectional area of median nerve in 3 locations | Measured by real-time grayscale ultrasound | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment |
| Quick DASH Patient Survey Score | This questionnaire asks the patient about their symptoms as well as their ability to perform certain activities. The QuickDASH, published in 2005 in the Journal of Bone and Joint Surgery, is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb. | Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks) |
| CTS-6 Evaluation Tool Score | The Value Added by Electrodiagnostic Testing in the Diagnosis of Carpal Tunnel Syndrome completed by the clinician. A score >12 = 0.80 probability of Carpal Tunnel Syndrome and a score >5 = 0.25 probability of Carpal Tunnel Syndrome. | Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks) |
| Elasticity of the transverse carpal ligament | Measured by shear wave elastography. | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment |
| Elasticity of the subsynovial connective tissue in the carpal tunnel |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Distal Latency | Time it takes for an impulse to traverse the segment nearest the muscle. | Baseline and at 8 weeks (end of study) |
| Sensory Distal Latency | Time it takes for an impulse to traverse the segment nearest the muscle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Gazaille, DO | Kettering Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kettering Health | Dayton | Ohio | 45458 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2024 | Feb 23, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Conservative treatment | Other | Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical therapy will be excluded from the conservative therapy regimen. |
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Measured by shear wave elastography. |
| baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment |
| Baseline and at 8 weeks (end of study) |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D012046 | Rehabilitation |