Cervical RadiculopathyNCT01495728
Thoracic Manipulation in Patients With Cervical Radiculopathy
A study testing Thrust Manipulation - Thoracic Spine in people with Cervical Radiculopathy, run by Spine and Sport, Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Thrust Manipulation - Thoracic Spine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 yrs
- 3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Spine and Sport
Savannah, Georgia, 31401
Ian A Young, PT, DSc, 912-443-1400, youngian@spinesport.org
Ian A Young, PT, DSc
About this study
Official title: Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy
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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Thrust Manipulation - Thoracic Spine, Sham Manipulation
- Keywords
- Cervical Radiculopathy, Neck Pain, Manipulation
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust Manipulation - Thoracic SpineProcedure or surgery
Mid and Upper Thoracic Spine
Sham ManipulationProcedure or surgery
Mid and Upper Thoracic Spine
| Study group | Role | What they receive |
|---|---|---|
| Thrust Manipulation -Thoracic Spine | Experimental | Mid and Upper Thoracic Spine Receives: Procedure: Thrust Manipulation - Thoracic Spine |
| Sham Manipulation | Placebo comparator | Mid and Upper Thoracic Spine Receives: Procedure: Sham Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating of Change
Perceived Improvement
Measured: Pre Treat, Immed, 48-72 hours
Numeric Pain Rating Scale (Neck & Upper Extremity)
Pain
Measured: Pre Treat, Immed, 48-72 hrs
Secondary outcomes (4)
Neck Disability Index
Disability
Measured: Pre Treat, Initial, 48-72 hours.
Cervical Range of Motion
Measured: Pre-treat, immediate post, 48-72 hours
Deep Neck Flexor Endurance
Measured: Pre Treat, Immed, 48-72 hours
Numbness and Tingling Scale
Rating of distal paresthesia/numbness
Measured: Pre Treat, Immed, 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spine and Sport, Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Ian A Young, PT, DSc, Principal investigator, Spine and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495728
- Sponsor's protocol ID
- jacki2006
- Status last verified
- Dec 2011
- First submitted
- 16 Dec 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT01495728
- Acronym / sponsor ID
- jacki2006
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical Radiculopathy, Neck Pain, Manipulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spine and Sport, GeorgiaUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrust Manipulation -Thoracic Spine | Experimental | Procedure: Thrust Manipulation - Thoracic SpineMid and Upper Thoracic Spine |
| Sham Manipulation | Placebo comparator | Procedure: Sham ManipulationMid and Upper Thoracic Spine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 yrs
- 3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrust Manipulation - Thoracic SpineMid and Upper Thoracic Spine | Procedure or surgery | Thrust Manipulation -Thoracic Spine |
| Sham ManipulationMid and Upper Thoracic Spine | Procedure or surgery | Sham Manipulation |
Primary outcome
Global Rating of Change
Time frame: Pre Treat, Immed, 48-72 hours
Perceived Improvement
Numeric Pain Rating Scale (Neck & Upper Extremity)
Time frame: Pre Treat, Immed, 48-72 hrs
Pain
4 secondary outcomes
Neck Disability Index
Time frame: Pre Treat, Initial, 48-72 hours.
Cervical Range of Motion
Time frame: Pre-treat, immediate post, 48-72 hours
Deep Neck Flexor Endurance
Time frame: Pre Treat, Immed, 48-72 hours
Numbness and Tingling Scale
Time frame: Pre Treat, Immed, 48-72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian A Young, PT, DSc principal investigator
Spine and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust Manipulation - Thoracic Spine in people with Cervical Radiculopathy, run by Spine and Sport, Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian A Young, PT, DSc (912-443-1400, youngian@spinesport.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rating of Change (time frame: Pre Treat, Immed, 48-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011; AzTrials last refreshed its copy on 4 Nov 2026.