Thoracic Manipulation in Patients With Cervical Radiculop... | NCT01495728

Studies
Thoracic Manipulation in Patients With Cervical Radiculopathy

NCT01495728

Sponsor

Spine and Sport, Georgia

Status

Unknown status

Last Update Posted

Dec 20, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Cervical Radiculopathy

Interventions

Thrust Manipulation - Thoracic Spine
Sham 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

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Dec 16, 2011

First Submission Date that Met QC Criteria

Dec 19, 2011

First Posted Date

Dec 20, 2011Estimated

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

Dec 19, 2011

Last Update Posted Date

Dec 20, 2011Estimated

Name	Class
Virginia Commonwealth University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thrust Manipulation -Thoracic Spine	Experimental	Mid and Upper Thoracic Spine	Procedure: Thrust Manipulation - Thoracic Spine
Sham Manipulation	Placebo Comparator	Mid and Upper Thoracic Spine	Procedure: Sham Manipulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thrust Manipulation - Thoracic Spine	Procedure	Mid and Upper Thoracic Spine	Thrust Manipulation -Thoracic Spine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Rating of Change	Perceived Improvement	Pre Treat, Immed, 48-72 hours
Numeric Pain Rating Scale (Neck & Upper Extremity)	Pain	Pre Treat, Immed, 48-72 hrs

Secondary Outcomes

Measure	Description	Time Frame
Neck Disability Index	Disability	Pre Treat, Initial, 48-72 hours.
Cervical Range of Motion		Pre-treat, immediate post, 48-72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 yrs
3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy

Exclusion Criteria:

history of previous cervical or thoracic spine surgery
bilateral upper-extremity symptoms, signs or symptoms of upper motor neuron disease,
medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ian A Young, PT, DSc	Contact	912-443-1400		youngian@spinesport.org

Overall Officials

Name	Affiliation	Role
Ian A Young, PT, DSc	Spine and Sport	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spine and Sport	Recruiting	Savannah	Georgia	31401	United States

Condition Browse Module

MeSH Terms

ID	Term
D011843	Radiculopathy
D019547	Neck Pain

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided