Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion
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|ClinicalTrials.gov Identifier: NCT04308122|
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Posterior Cervical Spinal Surgery Myelopathy Cervical Radiculopathy, Cervical Spinal Stenosis Cervical Spondylosis, Cervical||Device: Cervical Orthosis (CO) Device: No Orthosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Active Comparator: Cervical Orthosis (CO)
Cervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion
Device: Cervical Orthosis (CO)
Immediately following surgery patients in the CO group will be fitted with a Philadelphia collar prior to being transferred to the recovery room. On the patient ward a physiotherapist will fit the patient with a Cervimax/Aspen/Miami J collar which will be worn at all times for 6 weeks according the standard of care.
Experimental: No Orthosis (NO)
No cervical orthosis will be worn after posterior cervical fusion
Device: No Orthosis
The NO group will have no specific precautions applied to their neck range of motion.
- Neck pain intensity [ Time Frame: Through study duration to 12 weeks ]numerical rating scale, 0 to 10 with higher scores indicating more severe pain
- Neck Disability Index [ Time Frame: Through study duration to 12 weeks ]NDI is a self-administered questionnaire with 10 questions. Each question is scored from 0 to 5 for a maximum score of 50 and the score converted to a percentage score. The scale ranges from 0 to 100 with a higher score denoting worse disability.
- Arm pain intensity [ Time Frame: Through study duration to 12 weeks ]numerical rating scale, 0 to 10 with higher scores indicating more severe pain
- General health SF12 [ Time Frame: Through study duration to 12 weeks ]is a generic, multidimensional self-report health questionnaireQuestions are categorized into scales for general health, physical functioning, social functioning, role limitation-physical, role limitation-emotional, mental health, energy/fatigue, pain, comparative health. These are summarized into the SF12-physical component summary score (PCS) and mental component summary score (MCS). Scores range from 0 to 100 with higher scores impling better functioning.
- Treatment satisfaction (% of patients satisfied) [ Time Frame: Through study duration to 12 weeks ]Treatment satisfaction will be assessed by the following question: "Are you satisfied with the results of your spine surgery?" using a 5-category scale as follows: 1) extremely satisfied, 2) somewhat satisfied, 3) Neither satisfied nor dissatisfied, 4) somewhat dissatisfied, 5) extremely dissatisfied.
- Time to meet discharge status (days) [ Time Frame: day 2 ]
measured as the number of days it takes to meet all discharge criteria including:
- Ambulating safely and independently as assessed by the physiotherapist
- Pain controlled with oral analgesics
- Minimal wound drainage following drain removal
- For the CO group only: proficient donning and doffing the CO as assessed by physiotherapy/occupation therapy
- Adverse Events rate (%) [ Time Frame: Through study duration to 12 weeks ]The Spinal Adverse Events Severity Grading System (SAVES) form will be used to capture intra-operative, peri-operative, and post-operative adverse events and serious adverse events.
- Pain medication usage [ Time Frame: Through study duration to 12 weeks ]The total dosage of opioids and NSAID for the hospital length of stay will be calculated. The type of medication used (over the counter, NSAID, muscle relaxant, narcotics, anti-depressant, neuroeleptic and other) will be indicated as not taken, as needed, and daily at week 2, 4, 6, and 12 after surgery.
- Range of motion [ Time Frame: Through study duration to 12 weeks ]Change in cobb angle in flexion-extension xrays and a goniometer to measure flexion-extension and rotation
- Compliance with wearing the collar (collar group only) [ Time Frame: Through study duration to 12 weeks ]Patients will be asked they used the collar as prescribed. If not, they will be asked if they wore the collar at all, and if yes for how many hours per day. Compliance will be defined as prescribed, irregular or aborted. Patients will be compliant if they wear the collar for> 20 hours per day.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308122
|Contact: Jennifer Urquhart||5196858500||Jennifer.Urquhart@lhsc.on.ca|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Jennifer Urquhart 519-685-8500 ext 53062 firstname.lastname@example.org|
|Principal Investigator:||Chris Bailey||London Health Science Centre|