- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850549
Preliminary Neck Classification Study
July 27, 2016 updated by: Kevin Farrell, St. Ambrose University
Implementation of a Neck Pain Classification System: A Preliminary Analysis
The purpose of this study was to assess if pain and function in patients with neck pain is less when physical therapists use a classification system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study was to prospectively assess pain and function scores in patients with neck pain, with therapists specifically trained to implement a treatment based classification and matched interventions system.
This study consisted of two phases to determine whether implementing a classification changed patient outcomes.
In phase one, baseline data was obtained while physical therapists continued with their current neck pain evaluation and intervention approaches.
The second phase involved educating the therapists in the neck classification system with the matched interventions.
Pain and function outcomes were analyzed for 2 phases.
The overall goal was to prospectively determine if the implementation of this classification system with matched interventions could enhance patient outcomes.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Moline, Illinois, United States, 61265
- Genesis Physical Therapy - King Plaza
-
Silvis, Illinois, United States, 61282
- Genesis Physical Therapy - Illini
-
-
Iowa
-
Bettendorf, Iowa, United States, 52722
- Genesis Physical Therapy - Maplecrest
-
Davenport, Iowa, United States, 52803
- Genesis Physical Therapy - Lombard
-
Davenport, Iowa, United States, 52807
- Genesis Physical Therapy - 53rd St
-
Davenport, Iowa, United States, 52807
- Genesis Physical Therapy - Valley Fair
-
Le Claire, Iowa, United States, 52748
- Genesis Physical Therapy - Le Claire
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Licensed physical therapists
- Treat patients with neck pain on a regular basis
Exclusion Criteria:
- Do not utilize interventions included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: physical therapy
Physical Therapy intervention provided by therapists in phase one without training in following a neck classification system and in phase two after being trained to follow a neck pain classification system.
|
Physical therapists treated patients in phase one as they usually do and in phase two were trained to follow a neck classification and matched intervention system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating (NPR)
Time Frame: up to 107 days
|
NPR was measured on initial evaluation and at the time the patient was discharged from care which varied for each patient (ranged from 3 to 107 days).
|
up to 107 days
|
|
Neck Disability Index (NDI)
Time Frame: up to 107 days
|
NDI was measured on initial evaluation and at the time the patient was discharged from care which varied for each patient (ranged from 3 to 107 days).
|
up to 107 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Visits
Time Frame: Measured from initial evaluation to time of discharge from care; up to 107 days.
|
Measured from initial evaluation to time of discharge from care; up to 107 days.
|
|
Duration of Care
Time Frame: Number of days of care, measured from initial evaluation to time of discharge from care; up to 107 days.
|
Number of days of care, measured from initial evaluation to time of discharge from care; up to 107 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
July 26, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (Estimate)
August 1, 2016
Study Record Updates
Last Update Posted (Estimate)
August 1, 2016
Last Update Submitted That Met QC Criteria
July 27, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- StAmbroseU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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