Development of a Clinical Prediction Rulefor Neck Manipul... | NCT01620905

Studies
Development of a Clinical Prediction Rulefor Neck Manipulation

NCT01620905

Sponsor

University of Nevada, Las Vegas

Status

Completed

Last Update Posted

May 12, 2016Estimated

Enrollment

82Actual

Phase

Not Applicable

Conditions

Mechanical Neck Pain

Interventions

Manipulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 13, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emilio J Puentedura, PT, DPT, PhD, Associate Professor, University of Nevada, Las VegasPrincipal Investigator

Lead Sponsor

University of Nevada, Las VegasOTHER

Collaborators

Name	Class
Franklin Pierce University	OTHER
University of Colorado, Denver	OTHER
International Spine Pain Institute	OTHER
Universidad Rey Juan Carlos

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cervical spine manipulation	Experimental	Subjects received cervical spine manipulation	Procedure: Manipulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manipulation	Procedure	Single level cervical spine joint manipulation	Cervical spine manipulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Rating of Change Scale	15 point likert scale rating perceived recovery	48 hours post intervention

Secondary Outcomes

Measure	Description	Time Frame
Numeric Pain Rating Scale	Average pain scores (0 - no pain to 10 - worst imaginable pain) taken for current rating, best in last 24 hours and worst in last 24 hours	48 hours and 96 hours post intervention
Neck Disability Index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 to 60 years
primary report of neck pain with or without unilateral upper extremity symptoms
baseline neck disability index score of 10 points (out of 50) or greater

Exclusion Criteria:

any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal
diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form)
bilateral upper extremity symptoms
evidence of central nervous system involvement
history of whiplash injury within 6 weeks of the examination
pending legal action regarding their neck pain
2 or more positive neurologic signs consistent with nerve root compression (changes in sensation, myotomal weakness, or decreased deep tendon reflexes)
any history of cervical spine surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNLV PT Department		Las Vegas	Nevada	89154	United States