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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01168986
• Other study ID #: 340-2009
• Secondary ID: 340-2009
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 22, 2010
• Last updated: March 17, 2015
• Start date: September 2009
• Est. completion date: August 2015

Study information

• Verified date: March 2015
• Source: University of Florida
• Contact: Joel E Bialosky, PhD
• Phone: 352-273-8636
• Email: bialosky[@]phhp.ufl.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Pulstar Multiple Impulse Therapy
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
• Exercise
Participants perform an exercise to strengthen the deep neck flexors

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 weeks	No
Primary	disability on the neck disability index	A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain	2 weeks	No
Primary	pain sensitivity using a numeric rating scale and a visual analog scale	self report of pain in corresponding to standardized pressure and thermal stimuli	2 week	No
Secondary	range of motion	neck range of motion including flexion, extension, sidebending, and rotation	2 weeks	No