Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
|ClinicalTrials.gov Identifier: NCT01518530|
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : October 29, 2013
Last Update Posted : October 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain||Device: Occiflex Robotic Intervention System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Passive Mobilization Cervical Spine
Patients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome.
Device: Occiflex Robotic Intervention System
Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.
- Occiflex Device Safety [ Time Frame: 6 weeks ]A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.
- Efficacy as Per the NDI-Neck Disability Index [ Time Frame: 6 weeks ]The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518530
|Hillel Yaffe Medical Center|
|Hadera, Israel, 38100|