The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2014 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168986
First received: July 22, 2010
Last updated: June 24, 2014
Last verified: June 2014
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
- pain score on a numeric rating scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
- disability on the neck disability index [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain
- pain sensitivity using a numeric rating scale and a visual analog scale [ Time Frame: 2 week ] [ Designated as safety issue: No ]self report of pain in corresponding to standardized pressure and thermal stimuli
Secondary Outcome Measures:
- range of motion [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]neck range of motion including flexion, extension, sidebending, and rotation
| Estimated Enrollment: | 66 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 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.
Other Name: Pulstar Multiple Impulse Therapy
|
|
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
Other Name: Exercise
|
|
No Intervention: No intervention
Participants receive/perform no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
Contacts
| Contact: Joel E Bialosky, PhD | 352-273-8636 | bialosky@phhp.ufl.edu |
Locations
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Joel E Bialosky, PhD | |
| Principal Investigator: Joel E Bialosky, PhD | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Joel E Bialosky, PhD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01168986 History of Changes |
| Other Study ID Numbers: | 340-2009, 340-2009 |
| Study First Received: | July 22, 2010 |
| Last Updated: | June 24, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
neck pain manual therapy exercise |
Additional relevant MeSH terms:
|
Neck Pain Nervous System Diseases Neurologic Manifestations Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015