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The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
This study has been completed.
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168986
First received: July 22, 2010
Last updated: May 11, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Neck Pain | Other: Pulstar Multiple Impulse Therapy Other: Exercise | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Enrollment: | 62 |
| Study Start Date: | September 2009 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pulstar Multiple Impulse Therapy
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
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
|
Other: Exercise
Participants perform an exercise to strengthen the deep neck flexors
|
|
No Intervention: No intervention
Participants receive/perform no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168986
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168986
Locations
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Joel E Bialosky, PhD | University of Florida |
More Information
| 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 ) |
| Study First Received: | July 22, 2010 |
| Results First Received: | January 28, 2016 |
| Last Updated: | May 11, 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 |
ClinicalTrials.gov processed this record on August 18, 2017