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

NCT ID: NCT01168986

Last Updated: 2016-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-05-31

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.

Detailed Description

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Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulstar Multiple Impulse Therapy

Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.

Group Type ACTIVE_COMPARATOR

Pulstar Multiple Impulse Therapy

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Participants perform an exercise to strengthen the deep neck flexors

No intervention

Participants receive/perform no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulstar Multiple Impulse Therapy

Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.

Intervention Type OTHER

Exercise

Participants perform an exercise to strengthen the deep neck flexors

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel E Bialosky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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340-2009

Identifier Type: OTHER

Identifier Source: secondary_id

340-2009

Identifier Type: -

Identifier Source: org_study_id

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