Neurophysiological Mechanisms ManipulationNCT02081430
Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds
A study testing CT Manipulation and Upper trapezius stretch in people with Neurophysiological Mechanisms Manipulation, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The purpose of this study is to determine the immediate effects of cervicothoracic manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and cervical ROM. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurophysiological Mechanisms Manipulation
- What is being tested?
- CT Manipulation and Upper trapezius stretch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of current neck pain
- Aged 18 - 70 years
- Able to lie on stomach or back without difficulty
Who cannot join
- 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
- History of neck whiplash injury
- Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
- Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
- Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
- Prior surgery to neck or upper back
Show all 9Show fewer
- A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
- Diagnosis from physician of fibromyalgia syndrome
- Currently pregnant, or could be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: The Immediate Effects of Cervicothoracic Manipulation vs. Stretching on Upper Trapezius Pressure Pain Thresholds and Cervical Spine Range of Motion
The purpose of this study is to determine the immediate effects of cervicothoracic manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and cervical ROM.
- Being tested
- CT Manipulation, Upper trapezius stretch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ManipulationProcedure or surgery
Upper trapezius stretchProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CT Manipulation | Experimental | Prone cervicothoracic manipulation Receives: Procedure: CT Manipulation |
| Upper trapezius stretch | Active comparator | Passive sustained stretch to upper trapezius muscle Receives: Procedure: Upper trapezius stretch |
| Control | No intervention | 8 Minute wait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold
Using a standardized pain pressure algometer, subjects will have recordings of pressure at which onset of pain is noted
Measured: up to 10 minutes
Secondary outcomes (1)
Cervical Range of Motion
Using a CROM device, cervical spine range of motion will be measured in angular degrees
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurophysiological Mechanisms ManipulationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
- Investigators
- Emilio J Puentedura, PT, DPT, PhD, Principal investigator, UNLVWilliam J Hanney, PT, DPT, PhD, Principal investigator, UCF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081430
- Sponsor's protocol ID
- UNLVPT-1301
- Status last verified
- Nov 2014
- First submitted
- 4 Mar 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Cervicothoracic Manipulation vs. Stretching on Upper Trapezius Pressure Pain Thresholds and Cervical Spine Range of Motion
- ClinicalTrials.gov ID
- NCT02081430
- Acronym / sponsor ID
- UNLVPT-1301
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Mar 2014 (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.
The purpose of this study is to determine the immediate effects of cervicothoracic manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and cervical ROM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT Manipulation | Experimental | Procedure: CT ManipulationProne cervicothoracic manipulation |
| Upper trapezius stretch | Active comparator | Procedure: Upper trapezius stretchPassive sustained stretch to upper trapezius muscle |
| Control | No intervention | –8 Minute wait |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Absence of current neck pain
- Aged 18 - 70 years
- Able to lie on stomach or back without difficulty
Key exclusion criteria (9 listed)
- 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
- History of neck whiplash injury
- Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
- Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
- Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
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 |
|---|---|---|
| CT Manipulation | Procedure or surgery | CT Manipulation |
| Upper trapezius stretch | Procedure or surgery | Upper trapezius stretch |
Primary outcome
Pain Pressure Threshold
Time frame: up to 10 minutes
Using a standardized pain pressure algometer, subjects will have recordings of pressure at which onset of pain is noted
1 secondary outcome
Cervical Range of Motion
Time frame: up to 10 minutes
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 5 Nov 2014.
Related trials for Neurophysiological Mechanisms Manipulation
Recruiting
The METRIC Study Protocol
Chronic Low-back Pain
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.
Emilio J Puentedura, PT, DPT, PhD principal investigator
UNLV
William J Hanney, PT, DPT, PhD principal investigator
UCF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Manipulation and Upper trapezius stretch in people with Neurophysiological Mechanisms Manipulation, 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 9 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 5 Nov 2014. 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?
Pain Pressure Threshold (time frame: up to 10 minutes). 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 5 Nov 2014.