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The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive Mobilization Cervical Spine | Experimental | Patients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occiflex Robotic Intervention System | Device | Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck. |
| Measure | Description | Time Frame |
|---|---|---|
| Occiflex Device Safety | A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Per the NDI-Neck Disability Index | The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
One recruited patient was dropped because of protocol violation.
From January 2012 to February 2012 twenty-three patients were screened and 10 were found to be eligible in the Physical Therapy Department of the Hillel Yaffe Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Neck Pain Patients Treated With Occiflex | Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Treatment Period |
| |||||||||||||
| Post-Treatment Follow-up |
|
One patient dropped out of the experiment due to lack of necessary documentation required for inclusion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Chronic Neck Pain Treated With Occiflex | Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occiflex Device Safety | A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted. | Posted | Number | Number of adverse effects | 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Chronic Neck Pain Treated With Occiflex | Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yaron River | Hillel Yaffe Medical Center | 972-523-756-446 | yaronr@hy.health.gov.il |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Efficacy as Per the NDI-Neck Disability Index | The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented. | Not Posted | 6 weeks |
| 0 |
| 9 |
| 7 |
| 9 |
| Dizziness | Ear and labyrinth disorders |
|
| Neck Pain | Musculoskeletal and connective tissue disorders |
|
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