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Thoracic Manipulation in Patients With Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrust Manipulation - Thoracic Spine
Sham Manipulation
Sponsored by
Spine and Sport, Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical Radiculopathy, Neck Pain, Manipulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Spine and SportRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thrust Manipulation -Thoracic Spine

Sham Manipulation

Arm Description

Mid and Upper Thoracic Spine

Mid and Upper Thoracic Spine

Outcomes

Primary Outcome Measures

Global Rating of Change
Perceived Improvement
Numeric Pain Rating Scale (Neck & Upper Extremity)
Pain

Secondary Outcome Measures

Neck Disability Index
Disability
Cervical Range of Motion
Deep Neck Flexor Endurance
Numbness and Tingling Scale
Rating of distal paresthesia/numbness

Full Information

First Posted
December 16, 2011
Last Updated
December 19, 2011
Sponsor
Spine and Sport, Georgia
Collaborators
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT01495728
Brief Title
Thoracic Manipulation in Patients With Cervical Radiculopathy
Official Title
Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spine and Sport, Georgia
Collaborators
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Cervical Radiculopathy, Neck Pain, Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thrust Manipulation -Thoracic Spine
Arm Type
Experimental
Arm Description
Mid and Upper Thoracic Spine
Arm Title
Sham Manipulation
Arm Type
Placebo Comparator
Arm Description
Mid and Upper Thoracic Spine
Intervention Type
Procedure
Intervention Name(s)
Thrust Manipulation - Thoracic Spine
Intervention Description
Mid and Upper Thoracic Spine
Intervention Type
Procedure
Intervention Name(s)
Sham Manipulation
Intervention Description
Mid and Upper Thoracic Spine
Primary Outcome Measure Information:
Title
Global Rating of Change
Description
Perceived Improvement
Time Frame
Pre Treat, Immed, 48-72 hours
Title
Numeric Pain Rating Scale (Neck & Upper Extremity)
Description
Pain
Time Frame
Pre Treat, Immed, 48-72 hrs
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
Disability
Time Frame
Pre Treat, Initial, 48-72 hours.
Title
Cervical Range of Motion
Time Frame
Pre-treat, immediate post, 48-72 hours
Title
Deep Neck Flexor Endurance
Time Frame
Pre Treat, Immed, 48-72 hours
Title
Numbness and Tingling Scale
Description
Rating of distal paresthesia/numbness
Time Frame
Pre Treat, Immed, 48-72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian A Young, PT, DSc
Phone
912-443-1400
Email
youngian@spinesport.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian A Young, PT, DSc
Organizational Affiliation
Spine and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine and Sport
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian A Young, PT, DSc
Phone
912-443-1400
Email
youngian@spinesport.org
First Name & Middle Initial & Last Name & Degree
Ian A Young, PT, DSc

12. IPD Sharing Statement

Learn more about this trial

Thoracic Manipulation in Patients With Cervical Radiculopathy

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