Phase 2
N=62
The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Neck Pain
Bottom Line
View on ClinicalTrials.gov: NCT01168986 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: 2 Week Change in Pain Score on a Numeric Rating Scale — 6.39; 20.37; 6.45 units on a scale — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pulstar Multiple Impulse Therapy (Other); Exercise (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2 Week Change in Pain Score on a Numeric Rating Scale |
6.39; 20.37; 6.45 | 0.10 |
| PRIMARY 2 Week Change in Disability on the Neck Disability Index |
4.44; 5.50; 0.42 | 0.18 |
| PRIMARY Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale |
0.58; -0.76; 1.62 | 0.87 |
| SECONDARY Change From Baseline in Neck Extension Range of Motion at 2 Weeks |
2.50; 1.32; -1.84 | 0.45 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01168986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.