Collar Use for Cervical Radicular Pain

Lifespan

Status: Completed

Conditions: Cervical Radiculopathy

Treatments: Other: Placebo; Other: Vista Therapy Collar

Study type: Interventional

Funder types: Other

Identifiers

NCT04163939

1426278

Details and patient eligibility

About

To evaluate the effectiveness of treatment in subjects with cervical radicular pain with Vista Therapy Collar, using a Visual Analog Scale, a Neck Disability Index and the SF-36 quality of life survey.

Full description

To evaluate the effective of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to a 'wait and see' approach.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age greater than 18 years

2. Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:

   • Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
   • Muscle weakness in one or more adjacent myotomes.

3. Neck Disability Index (NDI) score >= 10 points

4. VAS for neck pain >= 40

5. Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted

6. Subject is willing and able to attend visits as scheduled and to comply with the study protocol

Exclusion criteria

1. Serious somatic or psychiatric disorder
2. Previous Neck Surgery
3. Whiplash as the primary incident
4. History of spinal tumor or infection
5. Cervical Instability per opinion of PI
6. Morbid Obesity (BMI>40)
7. TMJ issues
8. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
9. Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
10. Subject is involved in Worker's Compensation litigation
11. Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups, including a placebo group

Collar

Experimental group

Description:

This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week

Treatment:

Other: Vista Therapy Collar

Control

Placebo Comparator group

Description:

This group will not wear the cervical collar

Treatment:

Other: Placebo