Text Size

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

This study is currently recruiting participants.
Verified May 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168986
First received: July 22, 2010
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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: April 2014
Estimated Primary Completion Date: April 2014 (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
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: May 9, 2013
Health Authority: United States: Institutional Review Board

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 May 22, 2013