Manual Therapy, Exercise and Traction for Patients With C... | NCT00695006

Studies
Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT

NCT00695006

Sponsor

Rocky Mountain University of Health Professions

Status

Unknown status

Last Update Posted

Jun 25, 2008Estimated

Enrollment

81Actual

Phase

Not Applicable

Conditions

Cervical Radiculopathy

Interventions

Sham Traction
Traction

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Jul 2008Estimated

First Submitted Date

Jun 9, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 11, 2008Estimated

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

Jun 24, 2008

Last Update Posted Date

Jun 25, 2008Estimated

Description Module

Brief Summary

To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.

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

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
II	Sham Comparator	Sham Traction	Other: Sham Traction
I	Active Comparator	Traction	Other: Traction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sham Traction	Other	Traction <5lbs	II
Traction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neck Disability Index		2wk, 4wk, 3mo, 6mo
Patient Specific Functional Scale		2wk, 4wk, 3mo, 6mo
Numeric Pain Rating Scale		2wk, 4wk, 3mo, 6mo

Secondary Outcomes

Measure	Description	Time Frame
Global Rating Of Change		2wk, 4wk, 3mo, 6mo
Body Diagram		2wk, 4wk, 3mo, 6mo
Fear Avoidance Belief Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3 of 4 positive on CPR, 18-70yrs

Exclusion Criteria:

history of previous cervical or thoracic spine surgery
bilateral upper extremity symptoms
signs or symptoms of UMN disease
medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
cervical spine injections (steroidal) in the past two weeks
current use of steroidal medication prescribed for their radiculopathy symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ian A Young, PT	Advance Rehab at Fredericksburg Orthopaedics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advance Rehab at Fredericksburg Orthopaedics		Fredericksburg	Virginia	22401	United States

Condition Browse Module

MeSH Terms

ID	Term
D011843	Radiculopathy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014143	Traction

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided