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

May 11, 2016 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks
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.
Immediate within session change pre to post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Joel E Bialosky, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 340-2009 (Other Identifier: University of Florida)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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