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

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pulstar Multiple Impulse Therapy
Exercise
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, manual therapy, exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Pulstar Multiple Impulse Therapy

Exercise

No intervention

Arm Description

Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.

Participants perform an exercise to strengthen the deep neck flexors

Participants receive/perform no intervention

Outcomes

Primary Outcome Measures

2 Week Change in Pain Score on a Numeric Rating Scale
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
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
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
change in neck extension range of motion over a 2 week period

Full Information

First Posted
July 22, 2010
Last Updated
May 11, 2016
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01168986
Brief Title
The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Official Title
The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, manual therapy, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulstar Multiple Impulse Therapy
Arm Type
Active Comparator
Arm Description
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Participants perform an exercise to strengthen the deep neck flexors
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants receive/perform no intervention
Intervention Type
Other
Intervention Name(s)
Pulstar Multiple Impulse Therapy
Intervention Description
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants perform an exercise to strengthen the deep neck flexors
Primary Outcome Measure Information:
Title
2 Week Change in Pain Score on a Numeric Rating Scale
Description
a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
Time Frame
2 weeks
Title
2 Week Change in Disability on the Neck Disability Index
Description
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.
Time Frame
2 weeks
Title
Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale
Description
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.
Time Frame
Immediate within session change pre to post intervention
Secondary Outcome Measure Information:
Title
Change From Baseline in Neck Extension Range of Motion at 2 Weeks
Description
change in neck extension range of motion over a 2 week period
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel E Bialosky, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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

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