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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Neck Pain	Other: Pulstar Multiple Impulse Therapy; Other: Exercise	Phase 1; Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
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
Study Start Date :	September 2009
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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. 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.
3. 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 :

1. 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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	July 23, 2010
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