Cervical RadiculopathyNCT04163939
Collar Use for Cervical Radicular Pain
A study testing Vista Therapy Collar in people with Cervical Radiculopathy, run by Rhode Island Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Vista Therapy Collar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- 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.
- Neck Disability Index (NDI) score >= 10 points
- VAS for neck pain >= 40
- Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted
- Subject is willing and able to attend visits as scheduled and to comply with the study protocol
Who cannot join
- Serious somatic or psychiatric disorder
- Previous Neck Surgery
- Whiplash as the primary incident
- History of spinal tumor or infection
- Cervical Instability per opinion of PI
- Morbid Obesity (BMI>40)
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- TMJ issues
- 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
- Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
- Subject is involved in Worker's Compensation litigation
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Spine Center, Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain
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.
Read the detailed 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Vista Therapy Collar, Placebo
- Keywords
- Neck pain
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vista Therapy CollarOther
The patient will wear the cervical collar
PlaceboOther
The patient will not wear the cervical collar
| Study group | Role | What they receive |
|---|---|---|
| Collar | Experimental | This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week Receives: Other: Vista Therapy Collar |
| Control | Placebo comparator | This group will not wear the cervical collar Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
Questionnaire used to measure how neck pain affects activities of daily living. Each of the 10 items are scored from 0-5, the maximum score is 50. Higher scores signify greater disability. A score over 34 signifies complete disability.
Measured: 90 days
SF-36 Quality of Life Survey
Questionnaire used to measure quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The total score is calculated as a percentage of the total points possible. A higher total percent signifies better outcomes.
Measured: 90 days
Visual Analog Scale (VAS)
Scale used to measure pain. The subject will mark their pain on a scale with a length of 100mm. The scale is scored by measuring (mm) from the left end of the scale to the subject's marking. The VAS is scored from 0-100, higher scores signify a greater amount of pain.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start30 Aug 2017
- Primary completion1 Apr 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the effectiveness of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to standard care.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Synovation Medical Group
- Responsible party
- Principal investigator, Alexios Carayannopoulos, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163939
- Sponsor's protocol ID
- 1426278
- Status last verified
- Jan 2023
- First submitted
- 1 Nov 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain
- ClinicalTrials.gov ID
- NCT04163939
- Acronym / sponsor ID
- 1426278
- Conditions
- Cervical Radiculopathy
- Keywords
- Neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Synovation Medical Group
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the effectiveness of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to standard care.
| Arm | Type | Receives |
|---|---|---|
| Collar | Experimental | Other: Vista Therapy CollarThis group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week |
| Control | Placebo comparator | Other: PlaceboThis group will not wear the cervical collar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than 18 years
- Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:
- Neck Disability Index (NDI) score >= 10 points
- VAS for neck pain >= 40
- Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted
Key exclusion criteria (11 listed)
- Serious somatic or psychiatric disorder
- Previous Neck Surgery
- Whiplash as the primary incident
- History of spinal tumor or infection
- Cervical Instability per opinion of PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vista Therapy CollarThe patient will wear the cervical collar | Other | Collar |
| PlaceboThe patient will not wear the cervical collar | Other | Control |
Primary outcome
Neck Disability Index (NDI)
Time frame: 90 days
Questionnaire used to measure how neck pain affects activities of daily living. Each of the 10 items are scored from 0-5, the maximum score is 50. Higher scores signify greater disability. A score over 34 signifies complete disability.
SF-36 Quality of Life Survey
Time frame: 90 days
Questionnaire used to measure quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The total score is calculated as a percentage of the total points possible. A higher total percent signifies better outcomes.
Visual Analog Scale (VAS)
Time frame: 90 days
Scale used to measure pain. The subject will mark their pain on a scale with a length of 100mm. The scale is scored by measuring (mm) from the left end of the scale to the subject's marking. The VAS is scored from 0-100, higher scores signify a greater amount of pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vista Therapy Collar in people with Cervical Radiculopathy, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.