NCT01495728

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

10 months

First QC Date

December 16, 2011

Last Update Submit

December 19, 2011

Conditions

Cervical Radiculopathy

Keywords

Cervical RadiculopathyNeck PainManipulation

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Neck Disability Index

    Pre Treat, Initial, 48-72 hours.

  • Cervical Range of Motion

    Pre-treat, immediate post, 48-72 hours

  • Deep Neck Flexor Endurance

    Pre Treat, Immed, 48-72 hours

  • Numbness and Tingling Scale

    Pre Treat, Immed, 48-72 hours

Study Arms (2)

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

Thrust Manipulation - Thoracic SpinePROCEDURE

Mid and Upper Thoracic Spine

Thrust Manipulation -Thoracic Spine
Sham ManipulationPROCEDURE

Mid and Upper Thoracic Spine

Sham Manipulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs
  • out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine and Sport

Savannah, Georgia, 31401, United States

RECRUITING

MeSH Terms

Conditions

RadiculopathyNeck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ian A Young, PT, DSc

    Spine and Sport

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian A Young, PT, DSc

CONTACT

912-443-1400youngian@spinesport.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

December 20, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

US(1)