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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Pulstar Multiple Impulse Therapy
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulstar Multiple Impulse Therapy<br>Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. | Other: Pulstar Multiple Impulse Therapy<br>* Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.<br>|
| Active Comparator: Exercise<br>Participants perform an exercise to strengthen the deep neck flexors | Other: Exercise<br>* Participants perform an exercise to strengthen the deep neck flexors<br>|
| No Intervention: No intervention<br>Participants receive/perform no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 Week Change in 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 | 
| 2 Week Change in Disability on the Neck Disability Index | 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. | 2 weeks | 
| Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | 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. | Immediate within session change pre to post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Neck Extension Range of Motion at 2 Weeks | change in neck extension range of motion over a 2 week period | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, neck pain, manual therapy