Neck PainNCT02552290
Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch
A study testing Upper Trapezius Stretch and Cervicothoracic manipulation in people with Neck Pain, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Upper Trapezius Stretch and Cervicothoracic manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 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
- 1. No current history or past history of neck pain; able to lie on back or stomach without difficulty
Who cannot join
- 'Red flag' items indicated in your 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 your 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 your 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 your 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 - Department of Physical Therapy
Las Vegas, Nevada, 89154
About this study
Official title: Effects of Cervicothoracic Manipulation and Passive Stretching to the Upper Trapezius Muscle on Pressure Pain Thresholds and Cervical Range of Motion on Healthy Individuals
The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain.
Read the detailed description
Not needed
- Conditions
- Neck Pain
- Being tested
- Upper Trapezius Stretch, Cervicothoracic manipulation, No intervention
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Trapezius StretchOther
Sustained stretch of upper trapezius muscle
Cervicothoracic manipulationOther
Manipulation to the cervicothoracic spine
No interventionOther
Wait
| Study group | Role | What they receive |
|---|---|---|
| Cervicothoracic manipulation | Active comparator | Description of a Right C7/T1 manipulation. The subject will lie prone. The therapist will stand on the L side of the subject facing in a cephalic direction (towards the patient's head). The therapist's right hand makes contact with the thumb on the right side of the spinous process of the first thoracic vertebra. The therapist left hand supports the head making contact on the temporal bone. The hand/neck is gently laterally flexed to the right, until slight tension is palpated in the tissues. A high-velocity low-amplitude thrust will be applied towards the subjects left side. If cavitation does not occur (an audible pop) the subject will be repositioned and the manipulation attempted a second time. A maximum of 2 attempts will be performed for each side of the neck. Receives: Other: Cervicothoracic manipulation |
| Upper trapezius stretch | Active comparator | The subjects will be in a supine position. A researcher will passively place the subject's head into flexion, side-bending away and rotation towards the side to be stretched until the muscle barrier is met. The researcher will depress the subject's shoulder with 100 Newtons of force measured with a Micro FET pressure dynamometer (Hoggan Health Industries, Salt Lake City, UT).) Once this pressure amount is achieved the stretch will be held for 30 seconds. This will be repeated two times on each side.
The subject will be asked to provide continuous feedback about the stretch felt and the degree of discomfort (if any) felt during the 30 second stretches. Receives: Other: Upper Trapezius Stretch |
| Control group | Other | Subjects assigned to the control group will receive no intervention. They will stay behind the curtained research area for approximately 3 minutes in a seated position. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Range of Motion
Cervical Range of Motion in each cardinal plane (sagittal, coronal and transverse) will be measured in angular degrees using a CROM device
Measured: Immediately after the intervention
Secondary outcomes (1)
Pain Pressure Threshold
Pain Pressure Threshold measured using a standard handheld algometer with 1 cm round tip
Measured: Two minutes and 5 Minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, 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, UNLV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552290
- Sponsor's protocol ID
- 1303-4412
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervicothoracic Manipulation and Passive Stretching to the Upper Trapezius Muscle on Pressure Pain Thresholds and Cervical Range of Motion on Healthy Individuals
- ClinicalTrials.gov ID
- NCT02552290
- Acronym / sponsor ID
- 1303-4412
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Sep 2015 (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 proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain.
Detailed description
Not needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervicothoracic manipulation | Active comparator | Other: Cervicothoracic manipulationDescription of a Right C7/T1 manipulation. The subject will lie prone. The therapist will stand on the L side of the subject facing in a cephalic direction (towards the patient's head). The therapist's right hand makes contact with the thumb on the right side of the spinous process of the first thoracic vertebra. The therapist left hand supports the head making contact on the temporal bone. The hand/neck is gently laterally flexed to the right, until slight tension is palpated in the tissues. A high-velocity low-amplitude thrust will be applied towards the subjects left side. If cavitation does not occur (an audible pop) the subject will be repositioned and the manipulation attempted a second time. A maximum of 2 attempts will be performed for each side of the neck. |
| Upper trapezius stretch | Active comparator | Other: Upper Trapezius StretchThe subjects will be in a supine position. A researcher will passively place the subject's head into flexion, side-bending away and rotation towards the side to be stretched until the muscle barrier is met. The researcher will depress the subject's shoulder with 100 Newtons of force measured with a Micro FET pressure dynamometer (Hoggan Health Industries, Salt Lake City, UT).) Once this pressure amount is achieved the stretch will be held for 30 seconds. This will be repeated two times on each side. The subject will be asked to provide continuous feedback about the stretch felt and the degree of discomfort (if any) felt during the 30 second stretches. |
| Control group | Other | Other: No interventionSubjects assigned to the control group will receive no intervention. They will stay behind the curtained research area for approximately 3 minutes in a seated position. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. No current history or past history of neck pain; able to lie on back or stomach without difficulty
Key exclusion criteria (9 listed)
- 'Red flag' items indicated in your 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 your 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 |
|---|---|---|
| Upper Trapezius StretchSustained stretch of upper trapezius muscle | Other | Upper trapezius stretch |
| Cervicothoracic manipulationManipulation to the cervicothoracic spine | Other | Cervicothoracic manipulation |
| No interventionWait | Other | Control group |
Primary outcome
Cervical Range of Motion
Time frame: Immediately after the intervention
Cervical Range of Motion in each cardinal plane (sagittal, coronal and transverse) will be measured in angular degrees using a CROM device
1 secondary outcome
Pain Pressure Threshold
Time frame: Two minutes and 5 Minutes after the 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 17 Sep 2015.
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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.
Emilio J Puentedura, PT, DPT, PhD principal investigator
UNLV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Trapezius Stretch and Cervicothoracic manipulation in people with 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 1 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 17 Sep 2015. 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?
Cervical Range of Motion (time frame: Immediately after the 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 17 Sep 2015.