Thoracic Manipulation in Patients With Cervical Radiculopathy

Cervical Radiculopathy Clinical Trial

Official title:

Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01495728
• Other study ID #: jacki2006
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2011
• Last updated: December 19, 2011
• Start date: September 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2011
• Source: Spine and Sport, Georgia
• Contact: Ian A Young, PT, DSc
• Phone: 912-443-1400
• Email: youngian[@]spinesport.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Procedure:
• Thrust Manipulation - Thoracic Spine
Mid and Upper Thoracic Spine
• Sham Manipulation
Mid and Upper Thoracic Spine

Locations

Country	Name	City	State
United States	Spine and Sport	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Spine and Sport, Georgia	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Rating of Change	Perceived Improvement	Pre Treat, Immed, 48-72 hours	No
Primary	Numeric Pain Rating Scale (Neck & Upper Extremity)	Pain	Pre Treat, Immed, 48-72 hrs	No
Secondary	Neck Disability Index	Disability	Pre Treat, Initial, 48-72 hours.	No
Secondary	Cervical Range of Motion		Pre-treat, immediate post, 48-72 hours	No
Secondary	Deep Neck Flexor Endurance		Pre Treat, Immed, 48-72 hours	No
Secondary	Numbness and Tingling Scale	Rating of distal paresthesia/numbness	Pre Treat, Immed, 48-72 hours	No