- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081430
Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds
November 3, 2014 updated by: Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89154
- University of Nevada Las Vegas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Absence of current neck pain
- Aged 18 - 70 years
- Able to lie on stomach or back without difficulty
Exclusion Criteria:
- '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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CT Manipulation
Prone cervicothoracic manipulation
|
|
|
Active Comparator: Upper trapezius stretch
Passive sustained stretch to upper trapezius muscle
|
|
|
No Intervention: Control
8 Minute wait
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
up to 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion
Time Frame: up to 10 minutes
|
Using a CROM device, cervical spine range of motion will be measured in angular degrees
|
up to 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emilio J Puentedura, PT, DPT, PhD, UNLV
- Principal Investigator: William J Hanney, PT, DPT, PhD, UCF
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 6, 2014
First Posted (Estimate)
March 7, 2014
Study Record Updates
Last Update Posted (Estimate)
November 5, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- UNLVPT-1301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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