The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
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ClinicalTrials.gov Identifier: NCT01168986 |
Recruitment Status
:
Completed
First Posted
: July 23, 2010
Results First Posted
: June 20, 2016
Last Update Posted
: June 20, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neck Pain | Other: Pulstar Multiple Impulse Therapy Other: Exercise | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Pulstar Multiple Impulse Therapy
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
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Other: Pulstar Multiple Impulse Therapy
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Active Comparator: Exercise
Participants perform an exercise to strengthen the deep neck flexors
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Other: Exercise
Participants perform an exercise to strengthen the deep neck flexors
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No Intervention: No intervention
Participants receive/perform no intervention
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- 2 Week Change in Pain Score on a Numeric Rating Scale [ Time Frame: 2 weeks ]a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
- 2 Week Change in Disability on the Neck Disability Index [ Time Frame: 2 weeks ]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.
- Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale [ Time Frame: Immediate within session change pre to post intervention ]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.
- Change From Baseline in Neck Extension Range of Motion at 2 Weeks [ Time Frame: 2 weeks ]change in neck extension range of motion over a 2 week period

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- currently experiencing neck pain which does not extend below the elbow
- pain at least 4/10 over the past 24 hours
- appropriate for conservative management of neck pain
- english speaking
Exclusion Criteria:
- surgery to the neck within the past 6 months
- systemic problem know to affect sensation
- other chronic pain condition other than neck pain
- neck pain as the result of trauma such as whiplash
- neck pain as the result of a fracture

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168986
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Joel E Bialosky, PhD | University of Florida |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT01168986 History of Changes |
Other Study ID Numbers: |
340-2009 340-2009 ( Other Identifier: University of Florida ) |
First Posted: | July 23, 2010 Key Record Dates |
Results First Posted: | June 20, 2016 |
Last Update Posted: | June 20, 2016 |
Last Verified: | May 2016 |
Keywords provided by University of Florida:
neck pain manual therapy exercise |
Additional relevant MeSH terms:
Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |