Neck PainNCT02850549
Preliminary Neck Classification Study
A study testing Procedure: physical therapy and Neck Pain Classification in people with Neck Pain, run by St. Ambrose University at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Procedure: physical therapy and Neck Pain Classification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Licensed physical therapists
- Treat patients with neck pain on a regular basis
Who cannot join
- Do not utilize interventions included in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Genesis Physical Therapy - Maplecrest
Bettendorf, Iowa, 52722
Genesis Physical Therapy - Lombard
Davenport, Iowa, 52803
Genesis Physical Therapy - 53rd St
Davenport, Iowa, 52807
Genesis Physical Therapy - Valley Fair
Davenport, Iowa, 52807
Genesis Physical Therapy - Le Claire
Le Claire, Iowa, 52748
Genesis Physical Therapy - King Plaza
Moline, Illinois, 61265
Genesis Physical Therapy - Illini
Silvis, Illinois, 61282
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Procedure: physical therapy and Neck Pain Classification
- Keywords
- neck pain, cervical, classification, outcomes, physical therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: physical therapy and Neck Pain ClassificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy | Other | 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. Receives: Other: Procedure: physical therapy and Neck Pain Classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating (NPR)
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).
Measured: up to 107 days
Neck Disability Index (NDI)
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).
Measured: up to 107 days
Secondary outcomes (2)
Number of Visits
Measured: Measured from initial evaluation to time of discharge from care; up to 107 days.
Duration of Care
Measured: Number of days of care, measured from initial evaluation to time of discharge from care; up to 107 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Ambrose University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Farrell, St. Ambrose University
- Investigators
- Kevin Farrell, Principal investigator, St. Ambrose University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850549
- Sponsor's protocol ID
- StAmbroseU2
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Neck Pain Classification System: A Preliminary Analysis
- ClinicalTrials.gov ID
- NCT02850549
- Acronym / sponsor ID
- StAmbroseU2
- Conditions
- Neck Pain
- Keywords
- neck pain, cervical, classification, outcomes, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Ambrose UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical therapy | Other | Other: Procedure: physical therapy and Neck Pain ClassificationPhysical 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Licensed physical therapists
- Treat patients with neck pain on a regular basis
Key exclusion criteria (1 listed)
- Do not utilize interventions included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure: physical therapy and Neck Pain ClassificationPhysical 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. | Other | physical therapy |
Primary outcome
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).
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).
2 secondary outcomes
Number of Visits
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Farrell principal investigator
St. Ambrose University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: physical therapy and Neck Pain Classification in people with Neck Pain, run by St. Ambrose University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating (NPR) (time frame: up to 107 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.