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| ID | Type | Description | Link |
|---|---|---|---|
| 340-2009 | Other Identifier | University of Florida |
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This study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. We are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulstar Multiple Impulse Therapy | Active Comparator | Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. |
|
| Exercise | Active Comparator | Participants perform an exercise to strengthen the deep neck flexors |
|
| No intervention | No Intervention | Participants receive/perform no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulstar Multiple Impulse Therapy | Other | Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 Week Change in Pain Score on a Numeric Rating Scale | a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable | 2 weeks |
| 2 Week Change in Disability on the Neck Disability Index | A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability. | 2 weeks |
| Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable. | Immediate within session change pre to post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Neck Extension Range of Motion at 2 Weeks | change in neck extension range of motion over a 2 week period | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel E Bialosky, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulstar Multiple Impulse Therapy | Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. |
| FG001 | Exercise | Participants perform an exercise to strengthen the deep neck flexors Exercise: Participants perform an exercise to strengthen the deep neck flexors |
| FG002 | No Intervention | Participants receive/perform no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulstar Multiple Impulse Therapy | Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. |
| BG001 | Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 2 Week Change in Pain Score on a Numeric Rating Scale | a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable | The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data | Posted | Mean | Standard Deviation | units on a scale | 2 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 | Pulstar Multiple Impulse Therapy | Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. |
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Participants were individuals with neck pain responding to a study and not necessarily seeking care. As a result, the findings may not directly translate to individuals with neck pain seeking care from a healthcare provider.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Bialosky, PT, PhD | University of Florida | 352-273-8636 | jbialosky@phhp.ufl.edu |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Other | Participants perform an exercise to strengthen the deep neck flexors |
|
Participants perform an exercise to strengthen the deep neck flexors Exercise: Participants perform an exercise to strengthen the deep neck flexors |
| BG002 | No Intervention | Participants receive/perform no intervention |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
| OG002 | No Intervention | Participants receive/perform no intervention |
|
|
|
| Primary | 2 Week Change in Disability on the Neck Disability Index | A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability. | The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data | Posted | Mean | Standard Deviation | 2 week change in units a scale | 2 weeks |
|
|
|
|
| Primary | Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable. | The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data | Posted | Mean | Standard Deviation | units on a scale | Immediate within session change pre to post intervention |
|
|
|
|
| Secondary | Change From Baseline in Neck Extension Range of Motion at 2 Weeks | change in neck extension range of motion over a 2 week period | The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data | Posted | Mean | Standard Deviation | degrees | 2 weeks |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Exercise | Participants perform an exercise to strengthen the deep neck flexors Exercise: Participants perform an exercise to strengthen the deep neck flexors | 0 | 21 | 0 | 21 |
| EG002 | No Intervention | Participants receive/perform no intervention | 0 | 21 | 0 | 21 |
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| D001519 | Behavior |