Trial Outcomes & Findings for Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain (NCT NCT01518530)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 weeks

Results posted on

2013-10-29

Participant Flow

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.

One recruited patient was dropped because of protocol violation.

Participant milestones

Participant milestones
Measure	Chronic Neck Pain Patients Treated With Occiflex Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
Active Treatment Period STARTED	10
Active Treatment Period COMPLETED	9
Active Treatment Period NOT COMPLETED	1
Post-Treatment Follow-up STARTED	9
Post-Treatment Follow-up COMPLETED	9
Post-Treatment Follow-up NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Chronic Neck Pain Treated With Occiflex n=9 Participants Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	47 years STANDARD_DEVIATION 11.21 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Region of Enrollment Israel	10 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Neck Pain Treated With Occiflex n=9 Participants Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
Occiflex Device Safety	26 Number of adverse effects

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Chronic Neck Pain Treated With Occiflex

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With Chronic Neck Pain Treated With Occiflex n=9 participants at risk Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
Nervous system disorders Headache	44.4% 4/9 • Number of events 8
Ear and labyrinth disorders Dizziness	44.4% 4/9 • Number of events 8
Musculoskeletal and connective tissue disorders Neck Pain	55.6% 5/9 • Number of events 10

Additional Information

Dr. Yaron River

Hillel Yaffe Medical Center

Phone: 972-523-756-446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place