- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02553759
Observed Actions in Chronic Neck Pain (ObACNPain)
September 17, 2015 updated by: Alfonso Gil Martínez, AG Clinic
Influence of the Actions Observed on Cervical Motion in Patients With Chronic Neck Pain. Randomized Controlled Trial
The aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP).
This study is a parallel-group double blind randomized clinical.
Outcome measures were CROM, and pressure pain detection thresholds (PPDT) with a digital algometer.
The follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
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 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non specific chronic neck pain
- Diagnosed by medical specialist
Exclusion Criteria:
- cervical osteoarthritis or polyarthrosis
- rheumatic disease
- history of cervical hernia
- whiplash syndrome
- surgery on the neck, face or shoulders,
- systemic disease, medical history of cancer
- significant trauma that the patient relates to their pain and/or refusal to participate
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Effective movement
This group will see a 1-minute video showing an individual performing a cervical rotation movement to each side, first 10 times towards the right and then 10 times towards the left.
The movement will be performed effectively over the entire course of the cervical path, approximately 80º
|
Patients observed movements without realize them.
After this actions, movements will be imagined by patients
|
|
Active Comparator: Ineffective movement
This group will see a 1-minute video showing an individual performing a cervical rotation movement ineffectively, without achieving the maximum cervical travel, performing approximately 40º.
First, 10 movements towards the right will be performed and then 10 towards the left
|
Patients observed movements without realize them.
After this actions, movements will be imagined by patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Range of motion degrees
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Alfonso Gil-Martínez, Master, Hospital Universitario La Paz
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
October 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
September 16, 2015
First Submitted That Met QC Criteria
September 17, 2015
First Posted (Estimate)
September 18, 2015
Study Record Updates
Last Update Posted (Estimate)
September 18, 2015
Last Update Submitted That Met QC Criteria
September 17, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ObActions
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.