Neck Pain
Conditions
Keywords
Chronic Neck Pain, Occiflex, Computerized Mobilization
Brief summary
The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.
Interventions
DEVICEOcciflex 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.
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain
Exclusion criteria
* Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occiflex Device Safety | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Per the NDI-Neck Disability Index | 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. |
Countries
Israel
Participant flow
Recruitment details
From January 2012 to February 2012 twenty-three patients were screened and 10 were found to be eligible in the Physical Therapy Department of the Hillel Yaffe Medical Center.
Pre-assignment details
One recruited patient was dropped because of protocol violation.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Chronic Neck Pain Treated With Occiflex Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Patients With Chronic Neck Pain Treated With Occiflex |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 47 years STANDARD_DEVIATION 11.21 |
| Region of Enrollment Israel | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Occiflex Device Safety
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.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Chronic Neck Pain Treated With Occiflex | Occiflex Device Safety | 26 Number of adverse effects |
Secondary
Efficacy as Per the NDI-Neck Disability Index
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.
Time frame: 6 weeks