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Use of cervical orthosis after instrumented posterior cervical spinal surgery is still widely practiced even though modern fusion techniques likely do not require additional stabilization from an external orthosis. This is a single, centre randomized, non-blinded equivalence trial. Patients undergoing multi-level posterior cervical fusion will be randomized to cervical orthosis (CO group) or no orthosis (NO group). 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. The NO group will have no specific precautions applied to their neck range of motion. Outcomes will be assessed prior to surgery, on the second day after surgery, and at 2, 4, 6 and 12 weeks after surgery. The primary outcome will be neck pain score on the numerical rating scale (ranging from 0-10 with higher scores indicating more severe pain) during the first 4 weeks after surgery with an equivalence margin of 2.0 points. Secondary outcomes will be neck disability, general health, treatment satisfaction, pain medication use, adverse events, neck range of motion, time meeting discharge status, and compliance in wearing the collar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Orthosis (CO) | Active Comparator | Cervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion |
|
| No Orthosis (NO) | Experimental | No cervical orthosis will be worn after posterior cervical fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Orthosis (CO) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neck pain intensity | numerical rating scale, 0 to 10 with higher scores indicating more severe pain | Through study duration to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index | 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. | Through study duration to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Bailey | London Health Science Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39167110 | Derived | Fernandes R, Thornley P, Urquhart J, Alahmari A, Alenezi N, Kelly S, Rasoulinejad P, Singh S, Siddiqi F, Gurr K, Bailey C. Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial. Eur Spine J. 2024 Oct;33(10):4002-4011. doi: 10.1007/s00586-024-08456-7. Epub 2024 Aug 21. |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D013122 | Spinal Diseases |
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|
| No Orthosis | Device | The NO group will have no specific precautions applied to their neck range of motion. |
|
| Arm pain intensity |
numerical rating scale, 0 to 10 with higher scores indicating more severe pain |
| Through study duration to 12 weeks |
| General health SF12 | 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. | Through study duration to 12 weeks |
| Treatment satisfaction (% of patients satisfied) | 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. | Through study duration to 12 weeks |
| Time to meet discharge status (days) | measured as the number of days it takes to meet all discharge criteria including:
| day 2 |
| Adverse Events rate (%) | 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. | Through study duration to 12 weeks |
| Pain medication usage | 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. | Through study duration to 12 weeks |
| Range of motion | Change in cobb angle in flexion-extension xrays and a goniometer to measure flexion-extension and rotation | Through study duration to 12 weeks |
| Compliance with wearing the collar (collar group only) | 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. | Through study duration to 12 weeks |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |