- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051478
Thoracic Manipulation and Mobilization for Neck Pain
January 30, 2014 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
CHANGES IN PRESSURE PAIN SENSITIVITY AND NECK PAIN AFTER THORACIC THRUST MANIPULATION OR NON-THRUST MOBILIZATION IN PATIENTS WITH MECHANICAL NECK PAIN
The purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
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
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
-
-
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
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mechanical idiopathic neck pain
- bilateral pain symptoms
- chronic pain (>3 months of duration)
Exclusion Criteria:
- whiplash injury
- previous spine surgery
- diagnosis of cervical radiculopathy or myelopathy
- diagnosis of fibromyalgia
- having undergone any physical therapy intervention in the previous year
- pregnancy
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thoracic manipulation
A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied.
|
A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied
|
Active Comparator: Thoracic mobilization
Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes
|
Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pressure pain thresholds
Time Frame: Change between baseline and 1o minutes immediate after the intervention
|
The amount of pressure applied for the pressure sensation to first change to pain will be assessed with an electronic algometer (Somedic AB, Farsta, Sweden) over the C5-C6 zygapophyseal joint, second metacarpal and tibialis anterior muscle
|
Change between baseline and 1o minutes immediate after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neck pain intensity
Time Frame: Change between baseline and 1o minutes immediate after the intervention
|
Participants will rate the intensity of their neck pain at rest on an 11-point numerical pain rate scale (NPRS, 0: no pain, 10: maximum pain)
|
Change between baseline and 1o minutes immediate after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jaime Salom.Moreno, PT, PhD, Universidad Rey Juan Carlos
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
September 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 28, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Estimate)
January 31, 2014
Last Update Submitted That Met QC Criteria
January 30, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- URJC2012/11
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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