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The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168986
First Posted: July 23, 2010
Last Update Posted: June 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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 )
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: January 28, 2016
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