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

Phase 1

Completed

• Conditions: Neck Pain
• Interventions: Other: Pulstar Multiple Impulse Therapy; Other: Exercise

• Registration Number: NCT01168986
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-01-28
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Results First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
2 Week Change in Pain Score on a Numeric Rating Scale	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 Week Change in Disability on the Neck Disability Index	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.
Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale	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

Name	Time	Method
Change From Baseline in Neck Extension Range of Motion at 2 Weeks	2 weeks	change in neck extension range of motion over a 2 week period

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States