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Clinical Trials/NCT01168986
NCT01168986
Completed
Phase 1

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

University of Florida1 site in 1 country62 target enrollmentSeptember 2009
ConditionsNeck Pain

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Neck Pain
Sponsor
University of Florida
Enrollment
62
Locations
1
Primary Endpoint
2 Week Change in Pain Score on a Numeric Rating Scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
May 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 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.

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 Outcomes

  • Change From Baseline in Neck Extension Range of Motion at 2 Weeks(2 weeks)

Study Sites (1)

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