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Status unknownNCT01495728Updated Dec 20, 2011

Thoracic Manipulation in Patients With Cervical Radiculopathy

An interventional study of Thrust Manipulation - Thoracic Spine and Sham Manipulation in Cervical Radiculopathy, sponsored by Spine and Sport, Georgia. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-12-20.

Sponsored by Spine and Sport, Georgia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cervical Radiculopathy

Keywords

  • Cervical Radiculopathy
  • Neck Pain
  • Manipulation
03

In context

Radiculopathy

498 studies on the registry are indexed under Radiculopathy; 144 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 385 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

This is the only study on the registry with Spine and Sport, Georgia as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Thrust Manipulation -Thoracic Spine

    Mid and Upper Thoracic Spine

    Procedure: Thrust Manipulation - Thoracic Spine

  • Placebo comparator
    Sham Manipulation

    Mid and Upper Thoracic Spine

    Procedure: Sham Manipulation

Interventions

  • ProcedureThrust Manipulation - Thoracic Spine

    Mid and Upper Thoracic Spine

  • ProcedureSham Manipulation

    Mid and Upper Thoracic Spine

06

What researchers measure

Primary outcomes

  1. Global Rating of Change

    Perceived Improvement

    Time frame: Pre Treat, Immed, 48-72 hours

  2. Numeric Pain Rating Scale (Neck & Upper Extremity)

    Pain

    Time frame: Pre Treat, Immed, 48-72 hrs

Secondary outcomes

  1. Neck Disability Index

    Disability

    Time frame: Pre Treat, Initial, 48-72 hours.

  2. Cervical Range of Motion

    Time frame: Pre-treat, immediate post, 48-72 hours

  3. Deep Neck Flexor Endurance

    Time frame: Pre Treat, Immed, 48-72 hours

  4. Numbness and Tingling Scale

    Rating of distal paresthesia/numbness

    Time frame: Pre Treat, Immed, 48-72 hours

07

Study locations

1 of 1 sites recruiting
  • Spine and Sport
    Savannah, Georgia 31401, United States
    • Ian A Young, PT, DSc · Contact · youngian@spinesport.org · 912-443-1400
    • Ian A Young, PT, DSc · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2011, a primary completion of Jul 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2011
First posted
Dec 20, 2011
Start
Sep 2011
Primary completionEst.
Jul 2012
CompletionEst.
Aug 2012
Last update
Dec 20, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01495728
Lead sponsor
Spine and Sport, Georgia
Collaborators
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Dec 20, 2011
Start date
Sep 2011
Primary completion
Jul 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Dec 20, 2011

Study contacts

Ian A Young, PT, DSc
Contact
youngian@spinesport.org
912-443-1400
Ian A Young, PT, DSc
principal investigator · Spine and Sport

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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