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

This study has been completed.
Sponsor:
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
  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:
  • 2 Week Change in 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

  • 2 Week Change in 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. 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
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

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 
Study First Received: July 22, 2010
Results First Received: January 28, 2016
Last Updated: May 11, 2016
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 September 27, 2016