Mechanical Neck PainNCT01620905
Development of a Clinical Prediction Rulefor Neck Manipulation
A study testing Manipulation in people with Mechanical Neck Pain, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18 to 60 years
- primary report of neck pain with or without unilateral upper extremity symptoms
- baseline neck disability index score of 10 points (out of 50) or greater
Who cannot join
- any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal
- diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form)
- bilateral upper extremity symptoms
- evidence of central nervous system involvement
- history of whiplash injury within 6 weeks of the examination
- pending legal action regarding their neck pain
- 2 or more positive neurologic signs consistent with nerve root compression (changes in sensation, myotomal weakness, or decreased deep tendon reflexes)
- any history of cervical spine surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise
Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.
- Conditions
- Mechanical Neck Pain
- Being tested
- Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManipulationProcedure or surgery
Single level cervical spine joint manipulation
| Study group | Role | What they receive |
|---|---|---|
| Cervical spine manipulation | Experimental | Subjects received cervical spine manipulation Receives: Procedure: Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating of Change Scale
15 point likert scale rating perceived recovery
Measured: 48 hours post intervention
Secondary outcomes (2)
Numeric Pain Rating Scale
Average pain scores (0 - no pain to 10 - worst imaginable pain) taken for current rating, best in last 24 hours and worst in last 24 hours
Measured: 48 hours and 96 hours post intervention
Neck Disability Index
10 item questionnaire measuring perceived disability (range 0 to 50)
Measured: 48 hours and 96 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startNov 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Neck PainStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- Franklin Pierce University, University of Colorado, Denver, International Spine Pain Institute, Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620905
- Sponsor's protocol ID
- UNLVPT08072806
- Status last verified
- May 2016
- First submitted
- 13 Jun 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise
- ClinicalTrials.gov ID
- NCT01620905
- Acronym / sponsor ID
- UNLVPT08072806
- Conditions
- Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- Franklin Pierce University, University of Colorado, Denver, International Spine Pain Institute, Universidad Rey Juan Carlos
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jun 2012 (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.
Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical spine manipulation | Experimental | Procedure: ManipulationSubjects received cervical spine manipulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18 to 60 years
- primary report of neck pain with or without unilateral upper extremity symptoms
- baseline neck disability index score of 10 points (out of 50) or greater
Key exclusion criteria (8 listed)
- any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal
- diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form)
- bilateral upper extremity symptoms
- evidence of central nervous system involvement
- history of whiplash injury within 6 weeks of the examination
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 |
|---|---|---|
| ManipulationSingle level cervical spine joint manipulation | Procedure or surgery | Cervical spine manipulation |
Primary outcome
Global Rating of Change Scale
Time frame: 48 hours post intervention
15 point likert scale rating perceived recovery
2 secondary outcomes
Numeric Pain Rating Scale
Time frame: 48 hours and 96 hours post intervention
Neck Disability Index
Time frame: 48 hours and 96 hours post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation in people with Mechanical Neck Pain, run by University of Nevada, Las Vegas 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 12 May 2016. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rating of Change Scale (time frame: 48 hours post intervention). 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 12 May 2016.