Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion

Radiculopathy, Cervical Clinical Trial

Official title:

A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308122
• Other study ID #: 1.1 - 22-Apr-2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: The London Spine Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 30, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Undergoing multi-level (2- or more level), open, posterior cervical fusion which may extent into the second thoracic vertebrae (C1-T2)

2. Able to consent to inclusion in the study

3. 18 years of age and older

Exclusion Criteria:

1. Spinal cord injury

2. Primary cervical spine infection

3. Cervical spine tumor

4. Inability to comprehend patient rated outcome instruments

5. Substance abuse

6. Dementia

7. Psychosis

8. Previous surgery at same level

Related Conditions & MeSH terms

• Myelopathy Cervical
• Posterior Cervical Spinal Surgery
• Radiculopathy
• Radiculopathy, Cervical
• Spinal Cord Diseases
• Spinal Stenosis
• Spinal Stenosis Cervical
• Spondylosis
• Spondylosis, Cervical

Intervention

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.
• No Orthosis
The NO group will have no specific precautions applied to their neck range of motion.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Christopher Bailey

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain intensity	numerical rating scale, 0 to 10 with higher scores indicating more severe pain	Through study duration to 12 weeks
Secondary	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
Secondary	Arm pain intensity	numerical rating scale, 0 to 10 with higher scores indicating more severe pain	Through study duration to 12 weeks
Secondary	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
Secondary	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
Secondary	Time to meet discharge status (days)	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	day 2
Secondary	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
Secondary	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
Secondary	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
Secondary	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